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Statement for the Record: The President’s 2026 Trade Policy Agenda

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May 6, 2026

The Honorable Jason Smith
Chairman
U.S. House Committee on Ways and Means
Washington, DC 20515

The Honorable Richard Neal
Ranking Member
U.S. House Committee on Ways and Means
Washington, DC 20515

Re: Statement for the Record – The President’s 2026 Trade Policy Agenda

 

Dear Chairman Smith and Ranking Member Neal:

Public Citizen, a nonprofit consumer advocacy organization with more than one million members and supporters, welcomes the opportunity to submit this statement for the record to the Ways and Means Committee hearing on the President’s 2026 Trade Policy Agenda.

For many years, U.S. trade policy rewarded companies for moving production to countries with lower wages, weaker labor protections, and weaker environmental rules. Those policies helped drive factory closures, diminish workers’ bargaining power, and increase inequality, while also contributing to environmental harm and migration pressures abroad. President Trump rose to power in part by promising to fix these problems.

The president’s trade agenda, released on March 2, 2026, makes several bold claims, focusing on the need to rebuild American industry. While in itself a laudable goal, the lack of substance in the policy indicates that this administration lacks a coherent plan to achieve any of its stated aims, including re-shoring manufacturing or advancing the interests of American workers. Additionally, Ambassador Jamieson Greer’s testimony before this Committee on April 22, 2026, cherry-picked facts to present an incomplete and false picture of the Trump administration’s disastrous trade policy. For example:

  • The administration has refused to acknowledge the 80,000 manufacturing jobs lost during Trump’s second term. Instead, Ambassador Greer pointed to a single quarter’s data (Q1 2026) to argue that Trump has “now reversed the trend of manufacturing job losses.” This ignores the thousands of Americans pushed out of work in Trump’s second term to date.[i]
  • Ambassador Greer claimed “our agricultural community is one of the largest beneficiaries” of America First policies, yet in 2025, global agricultural exports fell by $4.8 billion, some 6% from the previous year, and 23% less than in 2022.[ii] Soybean exports — the backbone of many farm economies — were among the hardest hit, falling over 30% in 2025, a decline directly related to a retaliatory trade war with China.[iii]
  • Ambassador Greer claimed that real manufacturing worker pay has increased by $2,400 in one year under President Trump. This statement is not supported by facts. Greer misquoted his own press release, incorrectly attributing figures from the mining sector, not manufacturing. The most recent Real Earnings release from the Bureau of Labor Statistics shows real average hourly earnings for all workers fell 0.6 percent in the last year (March 2025-March 2026) and production workers in manufacturing saw virtually no change in that time.[iv]

Simply put, working people are not benefiting from the administration’s chaotic approach to trade. Tariffs can be a useful tool when targeted to support critical industries, defend against unfair trade practices, and when linked to a broader plan to support domestic production and workers. However, this administration’s policy focuses on sweeping, unstrategic tariff threats, secretive pressure campaigns against other countries, and trade demands that place the interests of the biggest corporations over that of the public.

  1. Agreements on Reciprocal Trade

The 2026 Trade Policy Agenda identifies the Agreements on Reciprocal Trade (ART) as the centerpiece of this administration’s trade strategy. In his opening statement, Ambassador Greer boasted about concluding nine ARTs together with nine framework deals. However, the ARTs were based on illegally imposed tariffs, making it unsurprising that countries have already called into question the legality of these deals, which may not survive the test of time.

In addition, the terms of these deals make it clear that they constitute comprehensive and legally binding trade agreements. Yet, the deals were negotiated in complete secrecy, outside any formal delegation of congressional authority and without public participation. The USTR failed to publish negotiating drafts, undertake stakeholder consultations, or produce analyses of the elements and terms of the deals.

The unacceptable process under which the ARTs have been and continue to be negotiated is matched by concerning substantive rules. Several provisions in the ARTs target crucial public interest policies in the signatory countries that have been inappropriately labeled as “non-tariff barriers” in the administration’s 2025 and 2026 National Trade Estimate reports. These reports largely regurgitate a list of public-interest laws from around the globe that big corporations want removed, ranging from crucial digital economy regulations to climate and public health policies. The USTR must recognize that countries have a sovereign right to adopt measures in furtherance of public purposes, as done in the Biden administration’s NTE Report of 2024.

  1. An Agenda for Big Tech

Trump’s Trade Agenda, the provisions of ART texts to date, and the 2026 NTE Report make it clear that this administration will continue to target crucial digital economy regulations of foreign countries on behalf of Big Tech companies. We note, in particular, that the administration has sought to target:

  • Data protection and privacy regulations that seek to limit the ability of corporations to export data without implementing adequate privacy safeguards;[v]
  • Digital competition regulations that seek to promote a level playing field in the digital ecosystem and protect consumers from unethical practices of dominant enterprises;[vi]
  • AI regulations, like those in the EU, which impose safety and accountability obligations to AI systems, as well as regulatory measures to enhance transparency of AI systems by allowing regulators to access source code and algorithms prior to market access;[vii]
  • Digital taxation measures that seek to ensure Big Tech companies pay their fair share;
  • Online safety regulations that seek to prevent the spread of illegal content such as election misinformation, non-consensual intimate images, online violence, and hate speech;
  • Regulations that seek to protect traditional industries or local culture, such as Australia’s regulations requiring Big Tech companies to compensate news producers for reusing their content, or local content and language norms for online streaming services, as seen in Canada and Europe.

Targeting foreign digital regulations makes consumers of digital services the world over less safe, reduces the ability for smaller enterprises to compete in the digital economy, and concentrates power in the hands of Big Tech companies.

We caution the administration against conflating the profitability of Big Tech companies with the overall health of the U.S. economy or citizens’ economic well-being. Actions such as opposing foreign taxation of Big Tech companies, opposing regulatory action against anti-competitive and anti-privacy practices of Big Tech companies and so on, may appear to benefit the U.S. by boosting profits of Big Tech, but will ultimately reduce trust in U.S. technology companies and spur the development of local alternatives.

In addition, pursuing a deregulatory agenda abroad also harms U.S. consumers and small businesses. The last few years have seen increased debate over domestic regulation of technology in the U.S., particularly as the known and potential harms of digital platforms, AI systems, and unregulated data flows have become more apparent. Several domestic laws and policies — aimed at promoting a level playing field in the digital ecosystem, protecting user data, ensuring the safety of children online, and protecting vulnerable communities against harms caused by AI systems — are similar to the foreign laws targeted by the ARTs. It is, therefore, short-sighted and a clear abandonment of the national interest to attack the types of robust digital governance measures that should be adopted domestically.

Further, extreme free flow of data clauses in trade agreements are inconsistent with congressional and state-level actions to protect Americans’ data.[viii] Similarly, domestic online safety laws as well as AI regulations — including those imposing transparency and accountability requirements on AI companies in fields such as insurance, employment, and healthcare, or laws that seek to protect the public from harm caused by chatbots, intimate deepfakes, and election deepfakes — could be threatened by broadly worded anti-discrimination, source code secrecy, platform immunity and other provisions in digital trade chapters of trade agreements.

Rather than seeking to deregulate the digital ecosystem through undemocratic and unaccountable trade processes, digital trade chapters in trade agreements should, if included at all, focus solely on issues concerning the digitization of trade (e.g., improving customs facilitation). Trade negotiations are not a suitable venue for making binding decisions on how to regulate various aspects of the digital ecosystem, particularly when this could have significant implications on the ability of Congress or states to regulate risks posed by emerging technologies, and ensure a safer and more competitive digital economy.

Digital chapters in trade agreements should also include labor-related provisions that reduce dependence on forced or other forms of coercive labor in technology supply chains and do away with laws that enable technology companies to escape domestic liability for violations of labor, environmental, and other public interest laws.

  1. An Agenda for Big Pharma

A clear objective of this administration’s trade policy agenda, though not explicitly mentioned in the report, is to return the U.S. to a maximalist approach to intellectual property protections, even at the expense of public health. The use of ARTs and reciprocal tariffs to target foreign countries’ pharmaceutical pricing practices is a blatant attempt to push Big Pharma’s profit maximization agenda.[ix] Forcing other countries to pay more for medicines will not result in lower prices in the United States.[x] Americans pay high prices due to monopolistic pricing and weak domestic controls.

Instead of attacking policies that we ourselves should be emulating, the administration should take steps to maintain the availability and access to medicines by supporting stronger, more diversified supply chains, including through targeted approaches to bolster domestic capacity.

  1. USMCA and North American Trade

The 2026 trade agenda states that the ongoing review of the U.S.-Mexico-Canada Free Trade Agreement (USMCA) is a priority. Yet information provided to date provides no assurances that the administration will secure the serious, substantive improvements needed to fix the agreement to support working people across North America.

Public Citizen has joined nearly 700 civil society organizations in calling for the following changes to the USMCA:

  • The Rapid Response Mechanism (RRM) must be significantly strengthened and broadened to encompass all sectors of the economy, including agriculture.
  • Environmental rules must be enforceable in real time and with meaningful penalties. Environmental enforcement should include facility-specific tools modeled on the labor Rapid Response Mechanism to end social dumping or incentivize offshoring to avoid domestic safeguards.
  • Rules of origin and related provisions should be strictly revised to enhance real production in North America rather than allowing third countries backdoor access.
  • The agreement’s extreme digital trade rules should be revised or removed, as they limit Congress’s and states’ power to regulate large technology firms and protect consumers. Congress should reject rules that lock in Big Tech-friendly provisions concerning cross-border transfers of data, source code secrecy, broad platform liability protections, or that undermine antitrust or domestic taxation policies.
  • The USMCA’s intellectual property (IP) provisions that require patent term extensions, market exclusivity, patent linkage, and TRIPS-plus enforcement mechanisms should be removed to improve access to affordable, lifesaving medicines. The USMCA should affirm governments’ right to use compulsory licensing to address public health needs and to negotiate lower prescription medicine prices.
  • Certain Investor State Dispute Settlement (ISDS) provisions remain in the USMCA and should be fully removed.[xi] While the USMCA made significant progress by eliminating ISDS between the U.S. and Canada and restricting its application between the U.S. and Mexico, ISDS rights are preserved for companies with covered government contracts in Mexico in certain sectors.
  1. Critical Minerals Trade

As the United States seeks to build out a critical minerals supply chain, Congress should reject any trade agenda that treats resource-rich countries merely as a raw-materials store for U.S. industry.

Recent administration efforts, such as in the so-called “strategic partnership agreement” with the Democratic Republic of Congo, prioritize investor access and geopolitical advantage.[xii] Similarly, the ART with Indonesia commits Indonesia to remove key industrial policy tools that allow for value addition in its minerals supply chain, to facilitate U.S. coal imports, and to purchase $15 billion in fossil fuels.[xiii]

Both instances follow a similar pattern: the United States bullies a country to sign onto an ART that allows U.S. corporate interests to access and control mineral wealth, without implementing enforceable labor and environmental safeguards, or acknowledging indigenous rights. Thus, workers, communities, and producing countries bear the social and environmental costs while profits are exported to the U.S.

Congress should not accept a critical minerals policy built on secrecy, coercion, and corporate privilege. Any minerals agreement should be subject to full congressional review and approval, shaped through meaningful public participation, and conditioned on binding labor, environmental, human, and indigenous rights standards backed by strong enforcement mechanisms.

  1. Climate and the Environment

The America First Trade Policy wholly ignores “climate change” in the 2025 and 2026 agendas, even as other nations accept reality and advance forward-thinking measures such as the EU’s Carbon Border Adjustment Mechanism. Such policies address genuine cross-border risks, and U.S. trade policy should adopt and defend the space for such public-interest rules.

Despite some lip service to environmental protection in the ARTs, these agreements lock in a fossil fuel infrastructure that hastens climate harm.[xiv] The 2026 NTE report also attacks a host of climate-friendly policies the world over, including:

  • Policies to boost the clean energy transition, such as the EU’s Carbon Border Adjustment Mechanism (CBAM), the Renewable Energy Directive, the Deforestation-Free Supply Chain Regulation, the Eco Design for Sustainable Products Regulation, and the Sustainable Aviation Fuel Regulation
  • Green certification and local content policies, such as the UAE’s green certification program and India’s domestic content requirements for renewable energy government procurement contracts.
  • Policies to tackle plastic pollution, including Canada’s Zero Plastic Waste Agenda; United Arab Emirates ban on some single-use styrofoam products; Dominican Republic’s regulations prohibiting import of non-biodegradable straws and cutlery; Oman’s regulation on single-use plastic bags; and Cote d’Ivoire’s regulations on import of plastic bags.

Policies that aim to preserve biodiversity, prevent pollution, and protect the environment should not be attacked as trade barriers. To this end, we urge the administration not just to support the adoption of a Climate Peace Clause — a binding commitment by governments to refrain from using dispute settlement mechanisms in the WTO or other trade and investment agreements to challenge each other’s climate policies — but to implement such terms in its domestic trade policies, including future NTE reports.

  1. The Path Forward

The United States still lacks a strong industrial policy to rebuild domestic production and reduce dangerous supply chain weaknesses. Contrary to the Trump administration’s claims, a worker-centered trade policy cannot and should not rest on tariffs alone. A truly modern industrial strategy would commit to building durable new productive capacity, creating stable and resilient high-road supply chains, and implement the public investment, procurement rules, sector strategies, and worker protections needed to sustain industrial revival over time. In fact, the Trump administration has moved in the opposite direction by systematically dismantling the Inflation Reduction Act and public investment, including in critical scientific research.[xv]

Resilient domestic production requires targeted investment, stronger labor and environmental standards, diversified sourcing, and trade rules that support domestic capacity rather than simply reacting to trade imbalances after the fact. By contrast, this administration’s trade agenda remains legally precarious, democratically deficient, and economically punishing for American families.

The administration’s refusal to provide justification memos, rationale, or otherwise act with transparency further undermines its claims that the current tariff strategy is a serious step towards rebuilding American industry. We note, for instance, that the administration (both the White House and Office of the U.S. Trade Representative) has failed to release the full “Report to the President on the America First Trade Policy,” despite the public interest in disclosure of the reasons behind the implementation of “reciprocal tariffs” by this administration in April 2025. A Freedom of Information Act request seeking disclosure of this crucial report has also been left unanswered. Congress must demand full transparency into the administration’s tariff strategy, particularly given multiple reports indicating the possibility of insider trading, preferential exemptions, and other unethical practices.

Congress should reclaim its Article 1 Constitutional trade authority and hold the Trump administration accountable for its illegal tariffs and the secretive deals with other countries. All ARTs must be submitted for congressional approval.

Congress should also conduct oversight to ensure that investigations conducted by the USTR (including under Section 301) are not used as a political tool.[xvi] The misuse of these powers threatens the legitimacy of genuine investigations conducted by the USTR and could invite unwanted reciprocal action by foreign countries.

Meaningful Congressional oversight should extend to:

  • terminating President Trump’s emergency tariffs;
  • mandating full transparency in ART, critical minerals agreements, and other negotiations;
  • scrutinizing the tariff refund processes, to prevent mismanagement and abuse; and
  • investigating the administration’s tariff setting processes as well as the rationale for providing various exemptions. To date, the USTR and Trump have provided no clear guidance on tariff exemptions, their process, criteria, or oversight. Numerous reports indicate that certain companies, or their products, received tariff exemptions following political contributions, lobbying, and personal outreach with the Trump administration.[xvii]

The question before Congress in 2026 is not whether to go back to the old trade model or simply accept Trump’s shifting tariff policy. Trade policy should support industrial rebuilding, protect governments’ power to regulate in the public interest, center enforceable labor and environmental standards, reject new giveaways for Big Tech and Big Pharma, dismantle corporate courts, and improve transparency. U.S. trade policy should defend the space for those public-interest rules, not trade them away.

To that end, Congress must reject President Trump’s 2026 trade agenda. The country needs a worker-centered trade policy tied to industrial strategy, strong enforcement, public health, climate responsibility, fair competition, and democratic control over the rules that shape the economy.

 

[i] Adding insult to injury, those displaced workers no longer have access to federal retraining safety nets like the Trade Adjustment Assistance program, which Congress has failed to reauthorize since 2022.

[ii] Info accessible from International Trade Administration, U.S. Exports by Partner for NAICS code 111 – Agricultural Products in 2025.

[iii] Info accessible from International Trade Administration, U.S. Exports by Partner for HS code 1201: Soybeans.

[iv] Average Hourly Earnings of Production and Nonsupervisory Employees, Manufacturing

[v] The 2026 NTE report lists 27 jurisdictions allegedly imposing unfair restrictions on cross-border data transfers. A majority of the laws being targeted are data protection or privacy regulations that seek to ensure personal data is protected from unethical commercial exploitation.

[vi] The 2026 NTE report targets antitrust regulation in 10 jurisdictions, with the ARTs including sweeping “anti-discrimination” provisions that could be used against diverse digital economy regulations on the false basis that such laws or regulatory actions target or discriminate against U.S. entities.

[vii] The 2026 NTE Report lists the EU’s AI Act as a trade barrier (similar to last year) and also includes AI-related policies from five other jurisdictions as trade barriers, largely to oppose attempts to develop local AI ecosystems.

[viii] At the federal level, the U.S. restricts foreign data transfers under the Protecting Americans’ Data from Foreign Adversaries Act of 2024, Cybersecurity requirements for U.S Cloud Computing Contractors, and Executive Order 14117 – Preventing Access to Americans’ Bulk Sensitive Personal Data, and United States Government Related Data by Countries of Concern. At the state level, cross-border data transfers are restricted by laws such as Montana’s Genetic Information Privacy Act, and the 2023 Amendment to California’s Confidentiality of Medical Information Act. Refer Rethink Trade, The Digital Trade Data Heist, February 2025.

[ix] For example, the Trade Policy Agenda TPA states that Argentina committed to an ART that would “address long-standing intellectual property (IP) issues identified in previous Special 301 Reports … to repeal restrictive patentability criteria.” Patentability criteria are exactly the policy tools that governments use to prevent pharmaceutical evergreening and preserve access to affordable generics.

[x] See for example, the U.S.-UK Pharmaceutical Pricing Arrangement, which commits the UK to raising its spending on prescription drugs, an outrageous giveaway to Big Pharma, while doing nothing to lower prices in the U.S.

[xi] This mechanism has empowered foreign investors to sue governments in secretive, private arbitration panels, undermining democratic governance and critical public-interest regulation.

[xii] The DRC deal, for example, gives U.S. firms preferential access to mineral assets and a right of first offer over select mining sites while bullying its way into Congolese mineral governance by establishing a Joint Steering Committee stocked with U.S. Cabinet and IDFC representatives. U.S. State Department, Strategic Partnership Agreement Between the Government of the United States of America and the Government of the Democratic Republic of the Congo

[xiii] Indonesia also made significant concessions across digital policy, agriculture, health standards, and critical minerals, in exchange for a 19% “reciprocal” tariff rate. The White House, Trump Administration Finalizes Trade Deal with Indonesia, February 19, 2026

[xiv] For example, the ART with Indonesia requires the country to facilitate the importation of U.S. coal, including highly polluting metallurgical coal, and to purchase $15 billion in Liquefied Petroleum Gas and other fossil fuels. Agreement Between The United States Of America And The Republic Of Indonesia On Reciprocal Trade

[xv] In fact, it should be a matter of serious concern that China has surpassed the U.S. in research spending.

[xvi] For example, President Trump announced 50% punitive tariffs on Brazil via a social media post on July 9, 2025 in an attempt to interfere in Brazil’s domestic judicial processes on behalf of his long-time friend and ally, Jair Bolsonaro, while also seeking to help out his Big Tech buddies including Elon Musk, who were facing regulatory action in Brazil. Public Citizen, Written Testimony of Public Citizen to the U.S. Trade Representative Hearing on its Section 301 Investigation of Acts, Policies, and Practices of Brazil, September 2, 2025

[xvii] For example, the CBP reduced enforcement, rescinding a Withhold Release Order, following million-dollar donations to Trump-aligned committees. In another eyebrow raising example, the U.S. lowered tariffs on Swiss imports from 39% to 15% after Swiss billionaires gifted Trump a Rolex desk clock and a gold bar engraved with the numbers 45 and 47 valued at $130,000. New York Times, https://www.nytimes.com/2025/03/19/business/economy/trump-sugar-forced-labor-ban-lifted.html; The Guardian, Swiss gold and Rolex gifts to Trump arouse ‘disgust’ in Europe, November 21, 2025

Senate: Stop Trump’s Crypto Grift

Senate Banking Committee considers digital market legislation

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The Honorable Tim Scott, Chair
The Honorable Elizabeth Warren, Ranking Member
Honorable Members
U.S. Senate Banking Committee
Washington, D.C. 20510

Re: Ethics Requirements in Digital Asset Market Structure Legislation

Dear Chair, Ranking Member, and Members of the Committee,
On behalf of more than one million members and supporters of Public Citizen, we ask the Senate Banking Committee to establish strict ethics guardrails in digital market legislation. This must include prohibitions on federally elected officials, including the president, from engaging in any cryptocurrency venture. President Trump’s expansive ventures into crypto already violate several existing laws. Approving a bill that fails to confront these violations would explicitly declare that lawmakers countenance such infractions.
Specifically, we ask that any bill must include the following:
• Ban any form of crypto issuance, ownership, sponsorship, promotion, endorsement, and/or profiteering by a federally elected official, including the president and any family members.
• Require divestiture from any existing crypto venture. All proceeds must be disgorged and deposited in the U.S. Treasury or returned to investors.
• Establish civil and/or criminal monetary penalties for future infractions that must be two times the value of profits. The Attorney General shall bring a civil action against an individual in violation of these bans.
• Penalize crypto quid-pro-quo. Any federally elected official, including the president, who, directly or indirectly, corruptly demands, seeks, receives, accepts, or agrees to receive or accept anything of value personally, including crypto-related transactions, in return for the performance of any official act, shall be fined for at least two times the monetary equivalent of the thing of value, whichever is greater, or imprisoned for not more than five years, or both.

Trump’s crypto abuses include violations of anti-bribery statues, conflicts-of-interest laws, along with acts prohibited by the U.S. Constitution. Promotion of his meme coin constitutes a solicitation of a gift, which is a violation of 18 U.S.C. § 201. Trump pardoned a confessed money launderer after that individual transferred millions of dollars to one of the president’s crypto ventures. The president may neither solicit nor receive a bribe under 18 U.S.C. § 201. Trump accepted hundreds of millions of dollars from more than one foreign government for his crypto ventures, including his meme coin venture and a stablecoin. Four days before Trump took office, an entity controlled by the national security adviser of the United Arab Emirates purchased a 49% stake in a fledgling Trump crypto venture, putting $187 million into the coffers of the Trump family. The Constitution’s emoluments clause (Article 1, Section 9) prohibits acceptance of anything of value from a foreign government. These count as only a few of Trump’s illegal corruptions. Public Citizen recently documented Trump’s byzantine conflicts involving Binance, the world’s largest crypto exchange, which admitted to ignoring anti-money-laundering laws in 2023. Binance, however, has continued to help Iranian crypto traders skirt sanctions, according to recent media reports. Yet, at the same time Trump exposes American soldiers to the perils of war in Iran, his crypto venture is looking to increase its relationship with Binance.
By his own disclaimers, Trump’s crypto ventures do not fall within his official acts as president, and therein do not enjoy immunity provided by a Supreme Court decision.
An independent Attorney General (AG) would assign a special counsel to examine Trump’s corruption, paving the way for a post-presidential prosecution. This Department of Justice does not operate independent of Trump’s bidding. A clear-eyed Congress would impeach and convict Trump for these massive infractions. The current congressional majority remains blindered.
But responsible members of this committee cannot abdicate their obligation to prohibit this or any president from illegal profiteering as it considers any legislation.
Recently, the Senate unanimously approved a ban on its members participating in bets on prediction markets. Sen. Bernie Moreno (R-Ohio), the principal sponsor, explained, “United States senators have no business engaging in speculative activities like prediction markets while collecting a taxpayer-funded paycheck, period.”
Such laudable standards must also apply to the president and his crypto abuses.

For questions, please contact Bartlett Naylor at bnaylor@citizen.org.

Sincerely,

Public Citizen

Public Citizen Testimony to the Texas House State Affairs Committee Regarding Microgrids and Distributed Energy Resources

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To: The Honorable Ken King, Chair, House Committee on State Affairs; The Honorable Ana Hernandez, Vice-Chair, House Committee on State Affairs; Members, House Committee on State Affairs

From: Kaiba White, Public Citizen’s Texas office, kwhite@citizen.org

Microgrids and Distributed Energy Resources

Public Citizen appreciated the opportunity to provide information and policy recommendations relevant to the deployment of distributed energy resources

Distributed energy resources offer unique opportunity to provide kilowatt-hours to the electric grid, alleviate transmission needs, and improve grid and community resilience. Distributed energy resources can be deployed more quickly than utility scale resources or transmission infrastructure and thus offer an opportunity to avoid more costly transmission projects. Yet, even as Texas has excelled at deploying utility-scale resources, distributed energy resource deployment lags far behind. Key policy changes could unlock distributed energy potential in Texas.

Fair Compensation for Distributed Energy Resources

Utilities across Texas systematically discourage the use of distributed energy resources by establishing rate policies that dramatically undervalue energy provided to the grid. Texas has never had a statewide net metering or other distributed energy resource compensation policy beyond an ill-defined requirement to pay avoided cost. Thus, utilities have had broad latitude to assign avoided cost values with little or no analysis to support the validity of those values.

In 2024, Public Citizen released a study of rates and fees specific to residential customers with customer-sited distributed energy generation at all non-competitive Texas electric utilities to inform policymakers.[1] This scope included all 141 municipal and cooperative electric utilities in Texas, and monopoly investor-owned electric utilities that serve Texas customers outside of ERCOT. This research complemented an assessment by Solar United Neighbors (SUN) of distributed energy compensation policies offered by retail electric providers that serve customers in ERCOT’s competitive markets. We found that only 28 of the utilities offered net metering or a distributed generation rate that was comparable. The average avoided cost rate paid for energy sent to the grid from distributed energy systems was 43% of the retail rate charged for consumption from the grid. The avoided cost rates ranged down to just 17% of the retail rate. In the two years since we released this study, we have continued to track distributed generation compensation policies and have seen additional degradation of the value provided to customers through rates.  Some utilities that offered net metering when we first did this research have now replaced those policies with lower avoided cost rates.

These low distributed energy compensation rates play a significant role in slowing the deployment of these resources by lengthening the pay-back time for these resources. A customer’s energy usage patterns determine how sensitive they are to low compensation rates. Customers who are able to self-consume the energy they produce when it is produced are insulated from low compensation rates. They are, however, impacted by additional monthly fees and other discriminatory charges that at least 35 of the utilities levy on customers with distributed energy resources.  Customers who self-consume less of the energy they produce at the moment it is produced – which is often the case for those who work outside of the home during the day – are significantly impacted by low compensation rates. Rate policies at some utilities are so unfavorable that a customer who exports 50 percent of the energy produced from their distributed solar energy system wouldn’t pay back their investment for longer than 25 years (which is the typical warranty for sola panels). This is a clear discouragement to investing in distributed energy resources.

Not only are the distributed energy tariffs low, but the values assigned are often based on faulty assumptions and little or no expert analysis. Electric cooperatives and municipally owned electric utilities are often able to get rate changes approved by their boards of directors without substantial analysis or customer engagement. Avoided cost is frequently defined as the average cost of wholesale electricity for the utility. The monopoly vertically integrated utilities that must get rates approved by the Public Utility Commission of Texas (PUCT) aren’t held to a higher standard either.

For example, the PUCT recently overturned a recommendation from an administrative law judge (ALJ) in the El Paso Electric rate case and approved a discriminatory demand charge for residential customers with distributed energy resources. The ALJ recommended against this demand charge because El Paso Electric provided little evidence to support inaccurate assumptions about the costs and benefits of distributed energy generation to the utility. Also, demand charges are common for commercial customers, but are generally viewed as inappropriate for residential customers, who are less sophisticated and may have less ability to adjust demand patterns – especially for those who are at home during the day, including many retirees and parents with small children.

The situation in the competitive markets isn’t any better. There used to be several retail electric providers (REPs) that provided rate packages that included full net metering. That changed several years ago and there are now no full net metering options available in the competitive market. It is our understanding that this is in large part because of the REPs are charged by the transmission and distribution utilities (TDUs) in a way that doesn’t accurately value the avoided costs provided by distributed generation. This is a problem that could be remedied by the PUCT, but hasn’t been.

Instead of haphazardly guessing at the value of distributed energy resources, utilities should be required to conduct a thorough analysis of the costs and benefits, based on real data. The National Standard Practice Manual (NSPM) for Benefit-Cost Analysis of Distributed Energy Resources[2] provides a framework to do just that. The NSPM was developed by leading experts on distributed energy resource valuation and has been utilized in assessing the value of distributed energy resources in over a dozen jurisdictions. Factors that the NSPM framework identifies that apply to utilities and the grid include:

  • Generation benefits: avoided costs of energy generation, capacity, environmental compliance, and ancillary services and reduced market prices
  • Transmission benefits: conserving transmission capacity and avoiding transmission system losses.
  • Distribution system benefits: conserving distribution system capacity, avoiding distribution system losses, reducing distribution system operations and maintenance costs, and maintaining distribution system voltage.
  • Other benefits, including improved reliability and resilience, reduced risks, and reduced bad debt and disconnections.

In 2024, the Texas Solar Energy Society commissioned a study of the value of distributed solar energy to the ERCOT grid.[3] The study was conducted utilizing the NSPM and included an analysis of values to the ERCOT grid and some additional societal benefits. The study revealed that the generation, transmission, and distribution values provided by distributed solar energy resources total 15¢ per kilowatt-hour. Even though this calculation doesn’t account for the full avoided transmission costs that a utility can realize with distributed energy resources, it is more than triple what many Texas utilities are offering their customers for energy provided to the grid from distributed energy resources.

The Texas Legislature should pass legislation to establish a clear and comprehensive minimum standard for all Texas utilities to use when calculating compensation or avoided cost rates for energy exported to the grid from distributed energy resources, while allowing utilities to go beyond the minimum standard if they wish. A version of the methodology should be established for the TDUs as well. We recommend that the NSPM framework be the reference for these minimum standards.

Plug-In Solar

Plug-in solar systems typically range from 200 to 1,600 watts. They can plug into a wall outlet and don’t require professional installation. They are in widespread use in Germany and other parts of Europe, where there are several million systems in use.

Pug-in solar offers significant opportunity to expand access to distributed solar for residents who live in multifamily properties, are renters, or simply cannot afford to purchase a larger permanent solar installation for their homes. These small systems can yield several hundred dollars in annual savings on an electric bill and can also be paired with batteries to provide resilient back-up power for select appliances.

The states of Utah and Maine have passed laws setting standards for plug-in solar systems and establishing residents’ right to use compliant systems. Another 32 states, including Oklahoma, Wyoming and Idaho are considering legislation to enable the use of plug-in solar. The Texas Legislature should pass legislation to allow Texans to access these affordable and effective distributed energy systems.

Public Citizen welcomes the opportunity to work with members of the committee to advance these policy recommendations.

Colombia obtiene fallo favorable en el Tribunal Andino por la licencia obligatoria del dolutegravir — pero la batalla jurídica interna continúa

GHP Corp, Medicinas para la Gente Latinoamérica, Acción International para la Salud (AIS Peru), Public Citizen

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El Tribunal de Justicia de la Comunidad Andina declaró infundada la demanda de dos farmacéuticas multinacionales contra la licencia obligatoria del medicamento de primera línea para el VIH, en una decisión histórica para el acceso a medicamentos en la región. Sin embargo, siguen pendientes tres procesos judiciales ante tribunales colombianos.

Bogotá, Colombia — En una decisión de trascendencia regional, el Tribunal de Justicia de la Comunidad Andina falló a favor de Colombia el 27 de abril de 2026, declarando infundada la demanda presentada por las compañías ViiV Healthcare y Shionogi & Co., que alegaban un incumplimiento por parte del país ante la declaratoria de interés público del medicamento dolutegravir.

El fallo establece precedentes claros y concretos para la región latinoamericana:

  1. Las flexibilidades del ADPIC son defendibles. Los gobiernos que usen licencias obligatorias para proteger la salud pública cuentan ahora con un respaldo jurisprudencial supranacional sólido frente a posibles litigios de la industria farmacéutica.
  2. Los derechos de patente tienen límites frente a la salud pública. El fallo confirma que ninguna patente es absoluta cuando está en juego el acceso a tratamientos esenciales para poblaciones vulnerables.
  3. El uso gubernamental no comercial es una modalidad válida. La licencia colombiana fue otorgada exclusivamente para uso del Estado, lo que el Tribunal validó como una herramienta proporcionada y legítima.
  4. La temporalidad de una licencia debe estar condicionada a la realidad epidemiológica. No es necesario fijar una fecha rígida si las razones de salud pública persisten — una interpretación que abre espacio para políticas de salud más flexibles y adaptadas a contextos cambiantes.

El Tribunal concluyó que Colombia no incumplió la Normativa Andina ni las obligaciones derivadas de la Comunidad Andina, al considerar que la licencia obligatoria se ajustó a las reglas vigentes. Señaló además que el país había incorporado tanto las condiciones como los límites de vigencia de la medida, incluyendo un plazo determinado, y que los argumentos de las farmacéuticas no desvirtuaban la legalidad del proceso.

Una licencia obligatoria, el origen de la disputa

Una licencia obligatoria permite a un gobierno autorizar la producción o importación de versiones genéricas de un medicamento patentado, sin el consentimiento del titular de la patente, por razones de interés público. Esta herramienta está reconocida en el derecho internacional y forma parte de las flexibilidades del Acuerdo sobre los Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio (ADPIC) de la Organización Mundial del Comercio. Su uso permite reducir significativamente los costos de los medicamentos y ampliar el acceso a las poblaciones que más los necesitan.

En octubre de 2023, el gobierno colombiano inició el proceso de declaratoria de interés público sobre el dolutegravir, un fármaco de primera línea para el tratamiento del VIH, recomendado por la Organización Mundial de la Salud por su eficacia y menor tasa de efectos secundarios. Esta medida permite al Estado autorizar la compra o producción de versiones genéricas sin exclusividad del titular, reduciendo así los costos del medicamento.

En abril de 2024, la Superintendencia de Industria y Comercio otorgó la primera licencia obligatoria sobre el medicamento, y en junio ratificó esa medida al resolver los recursos presentados por ViiV Healthcare y Shionogi & Co., confirmando que el Estado puede autorizar la producción o importación de versiones genéricas aun cuando existe una patente vigente. Posteriormente se llevó a cabo el proceso de implementación de dicha licencia.

Antes de llegar al Tribunal, la Secretaría General de la Comunidad Andina ya había emitido en octubre de 2024 el Dictamen N° 004-2024, concluyendo que Colombia no había violado la normativa andina. Las farmacéuticas insistieron y escalaron el caso ante el Tribunal de Justicia de la Comunidad Andina en enero de 2025, cuestionando la legalidad de la licencia. Entre sus argumentos señalaron que la medida no definía con claridad su duración, que se otorgó sin criterios suficientes de temporalidad y que desdibujaba el carácter excepcional de este tipo de licencias.

Colombia argumentó que la licencia obligatoria se ajusta a la normativa andina y que su duración puede depender de las condiciones que dieron origen a la declaratoria de interés público, sosteniendo que se trata de una herramienta legítima de salud orientada a garantizar el acceso a tratamientos esenciales.

La batalla jurídica interna continúa:

No obstante la relevancia de este fallo, es importante precisar que la victoria ante el Tribunal Andino no cierra el expediente jurídico en su totalidad, siguen activos tres procesos judiciales ante tribunales colombianos:

  1. En el Consejo de Estado, bajo el radicado 11001032400020240006100, cursa una demanda de nulidad contra las resoluciones No. 1579 del 2 de octubre de 2023 y No. 2024 de 2023 expedidas por el Ministerio de Salud y Protección Social. El proceso se encuentra en el despacho
  2. En el Tribunal Administrativo de Bogotá, radicado 25000234100020240123400, cursa una demanda de nulidad y restablecimiento del derecho contra esas mismas resoluciones ministeriales. El proceso también se encuentra en el despacho.
  3. Un tercer proceso, radicado 250002341000202500159 00, cuestiona ante el Tribunal Administrativo de Bogotá las resoluciones No. 20049 del 23 de abril de 2024 y No. 34716 de 2024, emanadas de la Superintendencia de Industria y Comercio. En los tres procesos, diversas organizaciones de la sociedad civil, entre ellas PMA LAC y GHP Corp., intervienen como coadyuvantes en la defensa de la licencia.

Las actuaciones judiciales actualmente en trámite representan una oportunidad para que las autoridades nacionales continúen consolidando el marco institucional que respalda esta política pública. La decisión que se adopte contribuirá a fortalecer la seguridad jurídica, la coherencia entre instancias y la confianza en los mecanismos previstos por el ordenamiento jurídico.

Una resolución oportuna permitirá reafirmar el compromiso del Estado con la protección del derecho a la salud y con la implementación responsable de las herramientas disponibles en el derecho internacional para promover el acceso equitativo a medicamentos esenciales.

Si bien la patente del principio activo dolutegravir relacionada con la licencia obligatoria acaba de expirar (abril 28 de 2026), en otros países de la región y en Colombia continúan vigentes otras patentes relacionadas con este medicamento, particularmente en combinaciones terapéuticas utilizadas en los programas de VIH. Por tanto, este asunto no se cierra con el vencimiento de la patente base. El precedente fijado por el Tribunal Andino es relevante y debe servir como guía para Colombia y para otros países de la región al momento de evaluar el uso de las flexibilidades del ADPIC cuando persistan barreras derivadas de derechos exclusivos. La decisión reafirma que, ante tensiones entre intereses comerciales y la protección de la salud pública, los Estados conservan la facultad —y la responsabilidad— de priorizar el acceso oportuno y asequible a medicamentos esenciales.

Colombia wins favorable ruling at the Andean Tribunal on the dolutegravir compulsory license — but the domestic legal battle continues

GHP Corp, Medicinas para la Gente Latinoamérica, Acción International para la Salud (AIS Peru), Public Citizen

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The Andean Community Court of Justice dismissed as unfounded the complaint filed by two multinational pharmaceutical companies against the compulsory license for the first-line HIV medication, in a historic decision for access to medicines in the region. However, three legal proceedings before Colombian courts remain pending.

Bogotá D.C., Colombia — In a decision of regional significance, the Andean Community Court of Justice ruled in favor of Colombia on April 27, 2026, dismissing as unfounded the complaint filed by ViiV Healthcare and Shionogi & Co., which alleged that Colombia had violated its obligations under the public interest declaration for dolutegravir.

The ruling sets clear and concrete precedents for the Latin American Region:

  1. TRIPS flexibilities are defensible. Governments that use compulsory licenses to protect public health now have solid supranational jurisprudential backing against potential litigation by the pharmaceutical industry.
  2. Patent rights have limits when public health is at stake. The ruling confirms that no patent is absolute when access to essential treatments for vulnerable populations is at stake.
  3. Non-commercial government use is a valid modality. The Colombian license was granted exclusively for State use, which the Court validated as a proportionate and legitimate tool.
  4. The duration of a license must be conditioned on epidemiological reality. It is not necessary to set a rigid end date if the public health reasons persist — an interpretation that opens space for more flexible health policies adapted to changing contexts.

The Court concluded that Colombia did not breach Andean regulations or its obligations under the Andean Community, finding that the compulsory license was consistent with applicable rules. It further noted that Colombia had incorporated both the conditions and the duration limits of the measure, including a defined term, and that the pharmaceutical companies’ arguments did not undermine the legality of the process.

A compulsory license: the origin of the dispute

A compulsory license allows a government to authorize the production or importation of generic versions of a patented medicine, without the consent of the patent holder, for reasons of public interest. This tool is recognized under international law and forms part of the flexibilities of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization. Its use can significantly reduce drug costs and expand access for the populations that need them most.

In October 2023, the Colombian government initiated the process of public interest declaration for dolutegravir, a first-line HIV treatment drug recommended by the World Health Organization for its efficacy and lower rate of side effects. This measure allows the State to authorize the purchase or production of generic versions without the patent holder’s exclusivity, thereby reducing the cost of the medication.

In April 2024, the Superintendency of Industry and Commerce granted the first compulsory license for the medication, and in June confirmed that measure when resolving the challenges filed by ViiV Healthcare and Shionogi & Co., affirming that the State may authorize the production or importation of generic versions even where a patent is in force. The implementation process of the license subsequently took place.

Prior to reaching the Court, the General Secretariat of the Andean Community had already issued in October 2024 Dictamen N° 004-2024, concluding that Colombia had not violated Andean regulations. The pharmaceutical companies persisted and escalated the case before the Andean Community Court of Justice in January 2025, challenging the legality of the license. Among their arguments, they contended that the measure did not clearly define its duration, that it was granted without sufficient temporal criteria, and that it blurred the exceptional nature of such licenses.

Colombia argued that the compulsory license complies with Andean regulations and that its duration may depend on the conditions that gave rise to the public interest declaration, maintaining that it is a legitimate health tool aimed at ensuring access to essential treatments.

The domestic legal battle continues:

Notwithstanding the significance of this ruling, it is important to note that the victory before the Andean Tribunal does not fully close the legal docket — three judicial proceedings before Colombian courts remain active:

  1. Before the Council of State, under case number 11001032400020240006100, there is a nullity action against Resolutions No. 1579 of October 2, 2023 and No. 2024 of 2023 issued by the Ministry of Health and Social Protection. The case is currently pending before the chamber.
  2. Before the Administrative Court of Bogotá, case number 25000234100020240123400, a nullity and rights-restoration action has been filed against those same ministerial resolutions. This case is also pending before the chamber.
  3. A third proceeding, case number 250002341000202500159 00, challenges before the Administrative Court of Bogotá Resolutions No. 20049 of April 23, 2024 and No. 34716 of 2024, issued by the Superintendency of Industry and Commerce. In all three cases, several civil society organizations — including PMA LAC and GHP Corp. — are participating as intervening parties in defense of the license.

The ongoing judicial proceedings represent an opportunity for national authorities to continue strengthening the institutional framework that underpins this public policy. Whatever decision is reached will contribute to reinforcing legal certainty, coherence across branches of government, and confidence in the mechanisms provided by the legal order.

A timely resolution will allow the State to reaffirm its commitment to protecting the right to health and to the responsible use of tools available under international law to promote equitable access to essential medicines.

Although the patent on the active ingredient dolutegravir related to the compulsory license has just expired (April 28, 2026), other patents related to this medication remain in force in Colombia and in other countries in the region, particularly in therapeutic combinations used in HIV programs. Therefore, this matter is not closed by the expiration of the base patent. The precedent set by the Andean Tribunal is relevant and should serve as a guide for Colombia and for other countries in the region when evaluating the use of TRIPS flexibilities where barriers arising from exclusive rights persist. The decision reaffirms that, when tensions arise between commercial interests and the protection of public health, States retain the authority — and the responsibility — to prioritize timely and affordable access to essential medicines.

Comments on the Maryland PDAB Draft Proposed Regulations on an Upper Payment Limit for Ozempic

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Maryland is working to support affordability through its Prescription Drug Affordability Board (PDAB). On April 22, 2026, the PDAB released draft proposed regulations for an Upper Payment Limit for Ozempic.

Ozempic (semaglutide) is manufactured by Novo Nordisk and approved by the FDA to help control blood sugar levels, reduce the risk of cardiovascular disease, and reduce the risk of worsening kidney disease in patients with type 2 diabetes. 

The pharmaceutical industry often fights efforts to rein in prescription drug costs by claiming that attempts to make drugs more affordable will harm the ability to invest in research and development for new medicines. In reality, pharmaceutical companies do not set prices based on a drug’s research and development cost. Rather, insulated from competition by monopoly protections, companies set prices based on what the market will bear and reap large profits in the process.

Novo Nordisk’s pricing and revenues for Ozempic cannot be explained by research and development (R&D) spending. The company has made over $69.5 billion in sales revenue from Ozempic since the drug’s launch in 2018. These revenues are an order of magnitude higher than even the most generous estimates of research and development costs that take into account failed candidates and a reasonable return on investment. Since Novo Nordisk launched Ozempic, the company has spent over $56.3 billion on share repurchases and shareholder dividends—1.7 times as much as it spent on R&D across its entire portfolio ($32.6 billion).[1]

Novo Nordisk sells the same drug at much lower prices in comparable countries and still makes a profit at those prices. Based on net price estimates, Ozempic is as much as five times as expensive in the U.S as in peer countries. Meanwhile, researchers estimate that the drug could be profitably manufactured for as little as around $3 for a monthly supply. 

Novo Nordisk’s patenting tactics could stave off generic competition — a proven way to lower prices — keeping prices higher for longer. Follow-on patents for semaglutide, many of which cover minor modifications, provide patent protections until 2042, ten years after the patent covering the drug substance expires.

We encourage the PDAB to act to reduce Ozempic costs and ensure Novo Nordisk cannot put profits over the needs of everyday Americans.

 

[1] Public Citizen analysis of company financial reports 2018–2025.

Outrage of the Month: The FDA, Peptides and RFK Jr.

Health Letter, May 2026

By Robert Steinbrook, M.D.
Director, Public Citizen's Health Research Group

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If you’re not outraged, you’re not paying attention!

Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.

On July 23 and July 24, 2026, the Food and Drug Administration (FDA) will hold a public meeting of the Pharmacy Compounding Advisory Committee to discuss easing restrictions on seven peptides that the agency removed three years ago from a list of bulk drug substances that compounding pharmacies can use. At a later meeting, the committee will consider wider access to an additional five peptides that were also banned in 2023.

Peptides are a favorite of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr, who has used them to treat his own injuries. They are also championed by many health and wellness influencers. They are short chains of amino acids, usually administered by injection (under the skin or into a vein). Since pressure to broaden access to peptides comes directly from the HHS secretary, the FDA will have to decide whether to stand up for science or acquiesce to Kennedy’s wishes.

There is no credible reason to believe that peptides deemed unproven or unsafe in 2023 are now miraculously safe and effective. If convincing data on the safety and effectiveness of any of the 12 peptides had emerged in recent years, such findings would already be widely known.

Unapproved peptides are touted for wound healing, inflammation, insomnia and many other uses. Some are approved as drugs based on clinical research, including insulin and glucagon-like peptide-1 (GLP-1) receptor agonists that are frequently used for Type 2 diabetes and weight management. However, the FDA has previously found that the unapproved peptides are either unproven, unsafe or both, and frequently are contaminated with other substances.

When the FDA banned the compounding of many peptides in 2023, it cited risks related to immune reactions (immunogenicity) for certain routes of administration, impurities and a lack of “sufficient information to know whether the drug would cause harm when administered to humans.” For one peptide, KPV, the FDA said it had “not identified any human exposure data on drug products containing KPV administered via any route of administration.”

On July 23, the committee will discuss BPC-157-, KPV-, TB-500- and MOTS-c-related bulk drug substances. The FDA has reviewed these substances for ulcerative colitis (BPC-157), wound healing and inflammatory conditions (KPV), wound healing (TB-500), and obesity and osteoporosis (MOTS-c). TB-500 is a synthetic version of a protein fragment known as thymosin beta-4, and the substances are used interchangeably.

On July 24, the committee will discuss emideltide, semax and epitalon. The FDA has reviewed these drug substances for opioid withdrawal, chronic insomnia and narcolepsy (emideltide); cerebral ischemia, migraine and trigeminal neuralgia (semax); and insomnia (epitalon).

At a later meeting, to be held before the end of February 2027, the committee will discuss cathelicidin (LL-37), GHK-Cu, Dihexa acetate, Melanotan II and mechano growth factor.

At present, the Pharmacy Compounding Advisory Committee has six vacancies, including the chairperson and a consumer representative. The committee has only three voting members and one industry representative. With new appointees before the July meeting, the committee could be filled with members who would rubber stamp Kennedy’s wishes, as has been the case with vaccine recommendations from the Advisory Committee on Immunization Practices at the Centers for Disease Control and Prevention.

Consistent with FDA and state regulations, compounding pharmacies can use bulk drug substances to make customized versions of medications and to mix drugs when there is a shortage of an approved version. However, compounded drug products are not approved by the FDA and are subject to lower regulatory standards than approved drugs. Public Citizen’s Health Research Group recommends that they not be used except in unusual situations when a patient’s medical needs cannot be met by an available FDA-approved drug.

The forthcoming Pharmacy Compounding Advisory Committee meeting and the subsequent FDA decisions about the 12 peptides under reconsideration are a key test of the agency’s credibility and its commitment to public health, rather than Kennedy’s ill-advised directives. All these peptides, like any new drugs, should go through the FDA’s standard approval process, not a more lenient workaround alternative pathway that defeats the agency’s purpose.

Product Recalls: March 11, 2026 – April 15, 2026

Health Letter, May 2026

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Note: Never stop taking a drug that appears on the product recall list without first talking to your doctor or pharmacist. Most recalls are limited to a single manufacturer and may not be related to the version of a particular drug you are taking. If a recall does relate to the version of the drug you are taking, you should not stop taking the drug until you discuss an alternative treatment with your doctor or pharmacist.

For Class 1 recalls, there is a potential for serious injury or death.

For Class 2 recalls, there is a potential for serious adverse events but a lower chance of the drug causing serious injury or death than in a Class 1 recall.

CLASS I

CLASS II

Children’s Ibuprofen oral suspension, 100 mg per 5 mL, 120 mL bottle. Manufactured for: Taro Pharmaceuticals, U.S.A, Inc. Lots #7261973A, 7261974A, exp. date: 01/27.

Cinacalcet Hydrochloride tablets, 30 mg, 60mg and 90 mg, 30 tablets per bottle. Manufactured by: Cipla Ltd. Manufactured for: Cipla USA, Inc. Lots #4PB0526, 4PB0527, 4PB0528, exp. date: 09/26; Lot #5PB0173, exp. 01/27; Lots #4PB0215, 4PB0216, exp. date: 03/26; Lots #4PB0515, 4PB0516, exp. 09/26; Lot #4PB0517, exp. 09/26; Lot #5PB0167, exp. 01/27; Lot #4PB0224, exp. date: 03/26; Lots #4PB0505, 4PB0506, 4PB0507, exp. date: 09/26; Lot #5PB0564, exp. date: 04/27.

Clonidine Transdermal System, 0.1 mg/day, 0.2 mg/day and 0.3 mg/day, cartons of 4 systems and 4 adhesive covers. Manufactured by: Actavis Laboratories UT Inc. Distribute by: Actavis Laboratories UT Inc. Lot #100060315, exp. 04/26; Lot #100068644, exp. 01/27; Lot #100060002; exp. date: 07/26; Lot #100066802, exp. date: 05/27; Lot #100053892, exp. date: 04/26; Lot #100057899, exp. date: 05/26; Lot #100062704, exp. date: 02/27.

Icosapent Ethyl capsules, 1 gram, 120 capsules per bottle. Manufactured by: Softgel Healthcare Pvt. Ltd., India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Lots #S2520249, S2520250, S2520267, exp. date: 01/27; Lots #S2520303, S2520305, S2520332, exp. date: 02/27; Lots #S2540208, S2540209, exp. date: 04/27.

Isotretinoin capsules, 30 mg and 40mg, 10 count prescription pack. Manufactured for: Teva Pharmaceuticals, USA. Lot#100055426, exp. date: 02/26; Lot #100071518, exp. date: 04/27; Lot #100072450, exp. date: 07/27; Lot #100075305, exp. date: 06/27; Lot #100075512, exp. date: 07/27; 100076103, exp. date: 07/27.

Levothyroxine Sodium tablets, 150 mcf, 1000 tablets bottle. Manufactured for: Macleods Pharma USA, Inc. Lot #16240062A, exp. date: 03/26.

Meclizine Hydrochloride tablets, 12.5 mg, 50-count (5X10 unit-dose blister packs). Distributed by: American Health Packaging. Lot #1213748, exp. date: 09/26; Lots #1215076, 1215077, exp. date: 10/26.

Memantine Hydrochloride extended-release capsules, 7mg, 100 capsules. Packaged and distributed by: Major Pharmaceuticals. Lot #N02425, exp. 05/27.

Pantoprazole Sodium delayed-release tablets, 40 mg, 1000-count bottle. Manufactured for: Camber Pharmaceuticals, Inc. Batch #FD253967, exp. date: 06/27.

Prazosin Hydrochloride capsules, 1 mg, 2mg and 5mg, 100-count bottle. Manufactured for: Biocon Pharma Inc. Manufactured for: Biocon Pharma Inc. Manufactured by: Appco Pharma LLC. Lot #2404160C, exp. date: 03/26; Lot #2404160C, exp. date: 03/26; Lot #2406253C, exp. date: 05/26; Lot #2407311C, exp. date: 07/26; Lot #2407312C, exp. date: 07/26; Lot #2408350C, exp. date: 07/26; Lot #2505172C, exp. date: 05/27; Lot #2506191C, exp. date: 06/27; Lot #2404153UC, exp. date: 03/26; Lot #2404154UC, exp. date: 03/26; Lot #2502055UC, exp. date: 01/27; Lot #2505173UC, exp. date: 05/27; Lot #2505175UC, exp. date: 05/27; Lot #2406255UC, exp. date: 05/26; Lot #2406256UC, exp. date: 07/26; Lot #2407313UC, exp. date: 07/26; Lot #2408351UC, exp. date: 07/26; Lot #2408352UC, exp. date: 07/26; Lot #2509311UC, exp. date: 09/27.

TraMADol Hydrochloride tablets, 50 mg, 500-count bottles. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Distributed by: Amneal Pharmaceuticals LLC. Lot #AM230987, exp. date: 05/26; Lot #AR232387, exp. date: 12/26.

Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 tablet bottles. Distributed by: Viatris Specialty LLC. Lot #8177156, exp. date: 02/27.

For more information about the drug recalls listed above, please visit http://www.accessdata.fda.gov/scripts/ires/index.cfm.

CONSUMER PRODUCTS

For a list of recent recalls of consumer products, please visit the Consumer Product Safety Commission website at http://www.cpsc.gov/en/Recalls/.

Public Citizen Comments Regarding the Draft Guideline on Implementation of Patent Linkage for Pharmaceutical Products in Malaysia

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Thank you for the opportunity to provide written comments to the National Pharmaceutical Regulatory Agency regarding the proposed implementation of the patent linkage mechanism in Malaysia.[1]

Public Citizen is a nonprofit consumer advocacy organization with over one million members and supporters. Public Citizen’s Access to Medicines Program works with partners across the United States and around the world to make medicines available for all through tools in policy and law.

We understand that the Patent Linkage Guideline (hereinafter the “Guideline”) aims to implement Malaysia’s commitments under the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) to provide a notification mechanism to patent holders, opportunity to seek legal remedies, and procedures to resolve patent disputes before marketing of an allegedly infringing pharmaceutical product.[2] We also understand that the Guideline’s objective is to balance regulatory efficiency with patent protection while ensuring continued access to medicines.[3] However, Public Citizen is concerned that the Guideline as currently proposed will adversely impact access to affordable medicines in Malaysia.

CPTPP provides two options for implementing “patent linkage.” The first option provides that a Party must either create a system to provide notice to a patent holder or allow for notification prior to the marketing of a competing product, or a product for an approved use, claimed under a patent. A Party also needs to provide adequate time and opportunity for a patent holder to seek remedies. The second option provides for a “hard” linkage system which prevents generics companies from receiving marketing approval during the patent term unless by consent or acquiescence of the patent holder. To comply with the CPTPP, Malaysia only needs to provide anotification system and availability of judicial remedies.

The Guideline goes beyond the minimum requirements in the CPTPP, proposing a system that requires a 45-day hold on a registration decision for a generic application containing a list of patents and pending patents and an automatic 12-month suspension of approval if the patent holder initiates court action within the 45-day period. This would allow patent holders to block the registration of generic medicines for marketing approval, even for spurious patents.

Evidence shows that patent linkage delays generic entry and can facilitate abuse, since the financial benefits to patent holders of deterring generic market entry may outweigh the risks of penalties. For example, a study by Mexico’s Federal Economic Competition Commission found the patent linkage system encourages legal disputes and abuse by patent holders seeking to delay competition. The Commission found that generic drugs entered the market on average two years after patent expiration, indicating barriers to competition and lost savings as spending is maintained on higher-priced patented products.[4]  Additionally, the U.S. Federal Trade Commission has noted the harmful impacts of improperly listed patents within the U.S. “hard” linkage system, stating that “[w]hen [the] stay [on approval of a generic application] is triggered by a patent that is improperly filed and does not meet the statutory listing criteria, the stay may improperly delay consumer access to a competing product that might reduce prices, improve quality and access, or both. Given the high cost of many drugs, even a short delay in competition can have enormous consequences for consumers in accessing cost-effective medications.”[5] Notably, the European Commission strictly prohibits patent linkage systems, finding that linkage creates unnecessary delays in generics market entry and unjustifiably blocks healthy competition and access to affordable medicines.[6]

We urge you to withdraw the proposed Guideline and to pursue meaningful consultations with civil society experts and patient organizations on the implementation of Article 18.53 of the CPTPP.

[1] https://upc.mpc.gov.my/main/user/view-consultations/232

[2] CPTPP, Article 18.53

[3]https://upc.mpc.gov.my/main/user/consultations/documents/view/consultations/documents/Vx0gJAiuAMcSRiigxHGEAzV3l9QVXegKfrPDf875.pdf

[4] https://www.cofece.mx/wp-content/uploads/2017/11/Studies-drugmarkets_vF-BAJA.pdf

[5] https://www.ftc.gov/news-events/news/press-releases/2023/11/ftc-files-amicus-brief-outlining-anticompetitive-harm-caused-improper-orange-book-listings

[6] https://www.medicinesforeurope.com/wp-content/uploads/2021/03/Medicines%20for%20Europe%20Position%20Paper%20On%20Patent%20Linkage%20-%20May%202019.pdf

Big Tech Keeps Selling AI. The Public Still Isn’t Buying It.

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After years of warning that artificial intelligence could pose catastrophic risks without safeguards, disrupt labor markets, strain energy systems, and even openly questioning whether data centers or humans are worthy of energy resources, major AI companies are now attempting to win the public over through massive lobbying spending and even setting up phony “coalitions” to trick advocates. These attempts at influencing politicians and the American public only come after years of public statements and product rollouts that have emphasized disruption first and little care for public impact.

Americans remain unconvinced.

Public Citizen’s new polling memo shows that across party lines, the public continues to distrust AI, support stronger regulation, and reject the idea that industry promises alone should guide deployment. Voters consistently express concern that AI will weaken job security, increase corporate power, outpace meaningful oversight, and expose children and consumers to new harms before adequate safeguards exist. Far from embracing Silicon Valley’s new sales pitch, polling shows sustained demand among Democrats, Independents, and Republicans for stronger public guardrails and accountability before AI becomes more deeply embedded in everyday life.


Across Parties, the Public Agrees AI Must be Regulated

Almost all Americans (97%) Agree That AI Safety and Security Should Be Subject to Rules and Regulations (Gallup / Special Competitive Studies Project: Sept. 2025).

  • 80% of U.S. adults believe the government should maintain rules for AI safety and data security, even if it means developing AI capabilities more slowly. This view is held by 88% of Democrats and 79% of Republicans and Independents.
  • More than seven in 10 (72%) say independent experts should conduct safety tests and evaluations of AI products and services.
  • Six in 10 Americans distrust AI somewhat (40%) or fully (20%).
  • Only 2% of U.S. adults fully trust AI’s capability to make fair and unbiased decisions, a figure within the poll’s margin of error.

AI is the Industry Americans Most Want to Regulate (YouGov: Sept. 2024).

  • 72% of Americans want more regulation of the AI industry, a 15-point increase since a similar poll a year earlier. This includes 83% of Harris supporters and 66% of Trump supporters.
  • Across the 40 industries asked about in the poll, AI is the industry that Americans in general and Trump supporters specifically are most eager to regulate.

Two Thirds of Americans Want AI Regulation (Center Square Voters’ Voice / Noble Predictive Insights: April 2025).

  • 64% of registered voters want the government to regulate AI.

On a Bipartisan Basis, Voters Overwhelmingly Favor Candidates Who Support AI Regulation (Artificial Intelligence Policy Institute: Jan. 2024).

  • 76% of voters, including 71% of Republicans, prefer a candidate running in their district who supports regulating AI because the risks it poses are so large.
  • 77% of voters, including 75% of Republicans, say government should do more to regulate AI.

By a 6-1 Margin, Americans Reject Tech Industry Self-Regulation of AI Risks (YouGov / Artificial Intelligence Policy Institute: Aug. 2023).

  • 72% percent of voters said they preferred slowing down the development of AI.
  • 82% of voters said they don’t trust tech company executives to self-regulate, and 56% said they would support a federal agency to regulate AI.

Americans Losing Faith in AI’s Potential for the Economy

There is a Large Lack of Trust in AI (IPSOS: March 2026).

  • Almost 75% of Americans believe there needs to be action taken by the government to prevent job loss from AI.
  • 66% of Americans agreed that the development of AI needs to slow down, while 76% feel that people need to keep up with the advancement of AI.
  • Only 11% of corporate communicators believe existing ethical policies are sufficient for widespread AI adoption.

Voters Increasingly Think AI Is Likely to Hurt the Economy (Data For Progress: February 2026).

  • 46% of voters think AI will likely hurt the economy, rising nine points from December 2025.
  • Only 28% of voters think AI will likely help the economy, down eight points from December 2025.

Advancements in AI Will Likely Lead to Decreased Job Opportunities According to 70% of Americans (Quinnipiac: March 2026).

  • These views are shared among Americans regardless of work environment, with 71% of white-collar workers and 73% of blue-collar workers believe AI will lead to a decrease in job opportunities.
  • Gen Z is the most concerned, with 81% thinking there will be a decrease.
  • Americans are overwhelmingly unwilling (80%) to work in a job where their direct supervisor was an AI program.

Americans Overwhelmingly Reject the Idea that Competition with China Justifies Leaving AI Unregulated (Artificial Intelligence Policy Institute: July 2024).

  • Three out of four American voters are skeptical of the argument that the U.S. should race ahead to build ever more powerful artificial intelligence, unconstrained by domestic regulations, in an effort to compete with China.
  • 75% of Democrats and 75% of Republicans believe that “taking a careful, controlled approach” to AI by preventing the release of tools that terrorists and foreign adversaries could use against the U.S. is preferable to “moving forward on AI as fast as possible to be the first country to get extremely powerful AI.”

Americans Reject Federal Preemption of State AI Regulation

Americans Overwhelmingly Oppose Federal Preemption of State AI Regulations (YouGov / Institute for Family Studies: Nov. 2025).

  • American voters oppose adding artificial intelligence preemption provisions to the National Defense Authorization Act by a decisive 3-to-1 margin. 57% of Americans oppose congressional efforts to block states from regulating AI through military spending legislation, while only 19% support such measures.
  • Among Trump voters, 43% oppose preemption compared to just 25% who support it. Among Harris voters, 70% oppose the provision.

By a Greater Than 2-1 Margin, Voters Overwhelmingly Reject Federal Preemption of State AI Regulation (Echelon Insights / Common Sense Media: May 2025).

  • Nearly three out of five likely voters oppose a moratorium on state-level AI regulation, including half of Republicans. A majority (53%) of likely voters said they trusted state and local leaders more than politicians in Congress when it comes to regulating AI appropriately.
  • By a more than three-to-one margin, voters trust states to regulate AI over the federal government.
  • 81% of likely voters agree that Congress should not ban states from enacting or enforcing their own laws when it comes to protecting kids’ safety and privacy online. 87% agree that states should be able to enforce laws and regulations around social media, including requiring warning labels for children.

Americans Are Demanding Stronger AI Regulation

80% of Voters Say Go Slow on AI Development (Fox News: Dec. 2025)

  • 8 in 10 voters favor a careful approach to developing AI to manage potential risks to the U.S.
  • Only 1 in 10 voters think the president should regulate AI.

Americans Overwhelming Support (73%) “Slow, Heavily Regulated” Development of AI (Future of Life Institute: Oct. 2025).

  • 57% of adults reject the development of “expert-level AI” under current conditions; 17% feel it should never be developed; and 40% think it should be halted until proven controllable and safe. Shockingly, only 5% of adults agree that AI should be developed “as quickly as possible.”
  • Almost three-in-four Americans support regulation “like pharmaceuticals with extensive testing before deployment.” Two-thirds (64%) of adults would like to see an “immediate pause” on the development of advanced AI until the technology is proven to be safe.

Public Worries About Inadequate AI Regulation (Pew Research Center: April 2025).

  • Both the public and experts worry the U.S. government will not go far enough in regulating AI. About six in ten U.S. adults and 56% of experts surveyed say they’re more concerned about this than about the government going too far.
  • Majorities in both parties – 64% of Democrats and 55% of Republicans – are concerned about insufficient AI regulation.
  • 59% of the public and 55% of surveyed experts have little or no confidence in U.S. companies to develop and use AI responsibly.

Americans Agree the Country Needs More AI Regulation (Quinnipiac: April 2025).

  • 73% of Americans think that businesses are not doing enough to be transparent about their use of AI.
  • 69% of Americans think that the government is not doing enough to regulate AI.
  • 86% of Americans are either very or somewhat concerned about political leaders using AI to distribute fake or misleading information.

Americans Are Worried About AI Risks (Pew Research Center: Sept. 2025)

  • A majority of Americans (57%) rate the risks of AI for society as high. Far fewer (25%) see high benefits. 

Americans Support a Wide Range of Specific AI Regulations

Americans Support Required Pre-Approval of New AI Technologies (AI Policy Institute for Transformer: Jan. 2025).

  • 73% of Americans support requiring companies to implement safety measures and security standards for advanced AI models, and mandatory pre-deployment approval from a government board that certified companies have properly accounted for extreme risks. Democrats and Republicans gave this proposal identical levels of support.
  • Only 7% of Americans want no regulation of AI.

Americans Overwhelmingly Favor Requiring Disclosure of Deepfake Political Ads (Tech Policy Press / YouGov: Aug. 2024).

  • 87% of voters back a disclosure requirement for generative AI in political ads.
  • 78% of voters want a ban on deceptive AI-generated content on social media that targets a candidate for federal office with the intent of influencing an election or soliciting funds.
  • 77% of voters want candidates for federal office to be able to sue to take down content when their voice or likeness is used in deceptive AI-generated content.

Voters Overwhelmingly Believe in Regulating Deepfakes and the Use of Artificial Intelligence (Data for Progress / Accountable Tech: Feb. 2024)

  • 85% of Democrats, 84% of Independents, and 81% of Republicans believe AI companies should be required to label AI-generated content when it’s used to influence an election.

Americans Favor Regulation to Protect Creators from AI Training (Artificial Intelligence Policy Institute: May 2024).

  • 60% of respondents said AI companies should not be able to train freely on public data, and nearly three out of four respondents said companies should be required to compensate the creators of that data.
  • 78% said there should be regulations on the use of public data to train AI models.
  • 61% favored taxing AI companies’ high energy use to support and upgrade the electrical grid infrastructure.

Parents Want More Guardrails on AI for Their Children (Echelon Insights: February 2026).

  • 79% of parents want to be involved in decisions relating to AI tools at their children’s schools.
  • Parents overwhelmingly (86%) believe AI chatbots should be required by law to provide warnings to minors before displaying text or content related to violence, self-harm, or abuse.
  • 85% of parents think it should be required by law to alert a minor’s parents if their child discusses something harmful or illegal with a chatbot.
  • 84% of parents would prefer having parental controls over AI chatbots, allowing them to limit what topics their children can discuss with chatbots.
  • 79% of parents feel minors need permission from a parent before using chatbots.

There is Massive Public Concern About Impact of AI Chatbots and Companions on Kids (Echelon Insights / Common Sense Media: May 2025).

  • 85% of registered voters are concerned about the effect of AI chatbots and AI companions on kids and teenagers.
  • 92% of registered voters are concerned about the impact of deepfakes.
  • 93% of registered voters are concerned about kids being exposed to AI-generated sexualized content.

Americans Worried About AI Deployment in Transportation, Job Decisions, Lending Decisions (Axios / Illinois Institute of Technology: Dec. 2021).

  • More than 70% of respondents distrust the use of AI for self-driving buses and airplane autopilot systems.
  • 69% percent said they would limit the use of AI for hiring decisions.
  • Nearly 60% distrust AI for loan applications and mortgage rates.
  • More than seven in ten liberals and conservatives overwhelmingly agree that there should be public or government oversight of the use of algorithms.
  • Three-quarters of those polled said tech companies are too big (80% of liberals and 83% of conservatives).
  • 81% think the government should be doing more to protect online privacy.

About 79% of Americans Say a Human Being Should Always Make The Final Decision Before Any Use of Lethal Force (Information Technology and Innovation Foundation: Feb. 2026).

  • 81% of Republicans and Democrats believe humans should always make the final decision before any use of lethal force.
  • About 75% feel that AI technology isn’t reliable enough to be trusted with life-or-death military decisions.
  • A little over half (54%) of adults are very concerned about AI-controlled weapons that select and fire on targets without human involvement.
  • Only 21% of Americans support developing and deploying AI-controlled weapons.