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Civil Society Letter: Advance the March-in Review Without Delay

More than 30 Organizations Write to Secs. Raimondo and Becerra

civil society letter re march-in review

On October 16, 2023, Public Citizen and allies wrote to Sec. Raimondo and Sec. Becerra, urging them to advance the interagency review of march-in rights without delay.

The groups’ letter comes after earlier this year, Secs. Raimondo and Becerra announced a whole-of-government review of march-in rights, including when to exercise them based on prices. This review has the potential to reorient administration policy to help put an end to big pharma price gouging of prescription drugs invented with the support of taxpayer dollars and to instead make these medicines affordable to everyone.

The full content of the letter is available below:

Dear Secretary Raimondo and Secretary Becerra,

The undersigned organizations, representing patients, consumers, health care providers are committed to ensuring patients have access to the medicines they need. We are grateful for the tireless work that Department of Health and Human Services employees are undertaking to enact Medicare drug price negotiations and other Inflation Reduction Act reforms that will provide patients long sought relief from excessive drug prices. We implore you to advance without delay the interagency review of march-in authority announced by your departments earlier this year.[i]

Taxpayers, through the federal government, spend more than $50 billion annually to undergird research and development (R&D) of prescription drugs.[ii] NIH funding has contributed to basic and applied research underlying virtually every new FDA-approved drug in recent years.[iii] In addition to this fundamental upstream support, increasingly, public sector research institutions and spin-off companies from these institutions provide key late-stage research contributions.[iv]

Despite the integral role in prescription drug R&D of the U.S. government and institutions it supports, drug corporations routinely charge U.S. patients multiple times the price they charge in other large, wealthy countries.[v] Even in cases of medicines that NIH scientists helped to invent, U.S. taxpayers almost always pay more than other patients around the world.[vi] These exorbitant prices strain family and health program budgets alike, and in the worst cases lead to patients rationing treatment due to unaffordable costs.[vii]

Your departments have indicated to congressional policymakers that it is the intent of the Interagency Working Group for Bayh-Dole to have published a final framework by the end of the year.[viii] We agree that publishing a final framework before the year is over is of utmost importance. Our groups hope that a successful resolution of this process will lead to your administration subsequently using Bayh-Dole authorities to confront drug corporations’ excessive pricing of taxpayer-funded drugs, thus any delay in this process could mean a delay in patients receiving relief from high drug prices.

Yet more than six months have passed since the interagency review was announced, and since then there has been no public update on the working group membership, process, timeline, or scope of work. We share lawmakers’ concerns that little time remains to publish a draft framework, provide stakeholders opportunity to comment in response, convene a workshop, and revise the framework to meet the goal of publishing a final framework before the end of the year.

Please proceed with the urgency in publishing the march-in rights framework that the lives of patients impacted by unaffordable prescription drug prices demand.


ACA Consumer Advocacy
AIDS Healthcare Foundation
American Family Voices
Be a Hero
Center for Popular Democracy
Consumer Action
Doctors for America
Families USA
Health Care Voices
Health GAP
Iowa Citizens for Community Improvement
Knowledge Ecology International
Labor Campaign for Single Payer
Metro New York Health Care for All
NETWORK Lobby for Catholic Social Justice
North Carolina Medicare For All Coalition
Our Revolution
People’s Action
Progressive Democrats of America
Progressive MD
Public Citizen
Rise Up WV
Salud Y Farmacos
Social Security Works
T1International, USA
Tennessee Health Care Campaign
The Revolving Door Project (RDP)
Unity Fellowship of Christ Church-NYC
Universities Allied for Essential Medicines
West Virginia Citizen Action Group
Yale Global Health Justice Partnership

[i] Department of Health and Human Services. “HHS and DOC Announce Plan to Review March-In Authority”. March 21, 2023. https://www.hhs.gov/about/news/2023/03/21/hhs-doc-announce-plan-review-march-in-authority.html

[ii] U.S. Senate Health, Education, Labor, and Pensions Committee Majority Staff. “Public Investment, Private Greed.” June 12, 2023. https://www.sanders.senate.gov/wp-content/uploads/Public-Medicines-Report-updated.pdf

[iii] Ekaterina Galkina Cleary, PhD; Matthew J. Jackson, PhD; Edward W. Zhou, PharmD. “Comparison of Research Spending on New Drug Approvals by the National Institutes of Health vs the Pharmaceutical Industry, 2010-2019. JAMA. April 28, 2023. https://jamanetwork.com/journals/jama-health-forum/fullarticle/2804378

[iv] Rahul K Nayak, resident physician; Jerry Avorn, professor of medicine; and Aaron S. Kesselheim, professor of medicine. “Public sector financial support for late stage discovery f new drugs in the United States: cohort study.” JAMA. October 23, 2019. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6812612/

[v] Andrew W. Mulcahy, Christopher M. Whaley, Mahlet Gizaw, Daniel Schwam, Nathaniel Edenfield, Alejandro Uriel Becerra-Ornelas. “International Prescription Drug Price Comparisons, Current Empirical Estimates and Comparisons with Previous Studies.” RAND Corporation. 2021. https://www.rand.org/pubs/research_reports/RR2956.html

[vi] U.S. Senate Health, Education, Labor, and Pensions Committee Majority Staff. “Public Investment, Private Greed.” June 12, 2023. https://www.sanders.senate.gov/wp-content/uploads/Public-Medicines-Report-updated.pdf

[vii] Berkeley Lovelace Jr. “1 in 5 older adults skipped or delayed medications last year because of cost”. NBC News. May 18, 2023. https://www.nbcnews.com/health/health-news/1-5-older-adults-skipped-delayed-medications-last-year-cost-rcna84750

[viii] Letter to Sec. Raimondo and Sec. Becerra from Rep. Doggett, Sen. Warren, and Sen. King. September 19, 2023. https://doggett.house.gov/sites/evo-subsites/doggett.house.gov/files/evo-media-document/bayh-dole-wg-follow-up-9.19.23.pdf