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Cures for the 21st Century: Five Simple Ideas Congress Has Ignored

Health Letter, April 2015

Sarah Sorscher, J.D., M.P.H.

Last year, as Congress was getting very little done in terms of passing new legislation, members of the House of Representatives quietly were laying the groundwork to introduce some dangerous new laws that would reshape the way the Food and Drug Administration (FDA) regulates the drug and medical device industry.

The 21st Century Cures initiative, launched last year by Republican Rep. Fred Upton of Michigan and Democratic Rep. Diana DeGette of Colorado, bore its first fruit in January in the form of a “discussion document” draft of a nearly 400-page bill.

Unfortunately, there is little to be excited about in the new legislation. While the 21st Century Cures initiative was presented as a bipartisan effort to “accelerate the pace of cures and medical breakthroughs in the United States,”[1] the discussion draft released in January consists of little more than a grab bag of unseemly giveaways to the pharmaceutical and medical device industries.

Too often, attempts to speed the pace of so-called “medical innovation” have come in one of two forms: pressing for faster approvals from the FDA, or granting stronger and longer patents and other intellectual property protections to new drugs in order to further hike the brand-name drug industry’s already obscene profits. The draft 21st Century Cures proposal does both: It speeds up approvals of new drugs and devices by undermining the FDA’s ability to require high-quality testing and offers an ironclad package of intellectual property protection that triples the length of time many drugs can be sold at monopoly prices after entering the U.S. market.[2]

The legislation pays little attention to ensuring that the drugs being developed and marketed are actually high quality, targeted toward the most important health problems and marketed in a way that will ensure they are used appropriately.

Faster FDA approvals and higher corporate profits do not pave the way to better health care. If Congress wants to transform the drug and medical device regulatory landscape for the 21st century, it should expand its vision beyond what has been tried in the past. Here are five simple ideas that have not received enough attention from Congress, aimed at improving the quality and use of drugs and medical devices in the future.

  1. Lower the costs of research by publishing clinical data.

    Vast amounts of clinical data are submitted to the FDA with each new drug approval application. Disclosure of this information not only would enhance understanding of how to use FDA-approved drugs safely and effectively, but also would help accelerate the discovery of new drugs, giving researchers more information about which drugs worked and which did not in clinical trials.

    Currently, the FDA cannot publish the detailed clinical trial reports submitted by companies because these reports are considered confidential and protected from disclosure. The reports contain detailed information about how each subject reacted to the drug during clinical testing, information that can be hugely valuable to researchers, for both understanding the approved drug and identifying new areas for research.

    Congress could change this limitation by requiring that clinical trial reports be published (with all identifying information about individual trial subjects removed to protect privacy). Similar efforts are well underway in Europe, where the European Medicines Agency will soon implement a policy to make available to certain researchers detailed clinical trial reports submitted to regulators.[3]


  2. Make antibiotics last longer by limiting overuse and misuse.

    Excessive use of antibiotics is a major problem contributing to the rise of antibiotic-resistant “superbugs.” The 21st Century Cures proposal actually fuels this problem: It contains a provision that would encourage overuse of new antibiotics in order to boost drug profits by paying hospitals a cash bonus through Medicare for every patient treated with a new antibiotic approved by the FDA under the bill.[4] Such a provision will likely lead to faster development of bacterial resistance to these new antibiotics.

    A truly innovative bill for the 21st century would find ways to curb overuse, rather than adding fuel to the fire. Congress could slow antibiotic resistance and preserve the effectiveness of new antibiotics by requiring the FDA to order a Risk Evaluation and Mitigation Strategy (REMS) for all antibiotics to ensure appropriate use. A REMS is a plan to control when and how a drug is used. Such plans already are used for many high-risk drugs and can include special required training and certification for health care providers who prescribe the drug, as well as a process for monitoring patients.[5]


  3. Create smart incentives to encourage rational drug development and use.

    The 21st Century Cures initiative has focused on strengthening and lengthening patents and intellectual property protection,[6] which has the effect of making drug development more profitable. However, this approach puts industry profits over patients and public health. One alternative that has received far too little attention is that of a large financial prize that could be offered for bringing a valuable new drug to market. Such a prize would focus on a high-value product, such as a drug for antibiotic-resistant infections.[7] Once approved, the drug could be sold by generic manufacturers, who compete based on pricing to keep costs low rather than spending money on marketing to press doctors to overprescribe.

    A nonprofit organization in the United Kingdom already has created one such large prize. The Longitude Prize offers 10 million British pounds, or about $15 million, to the first team to develop a new test for diagnosing infections and finding the right antibiotic to treat them.[8]


  4. Institute true medical device reform.

    Currently, too many moderate- and high-risk medical devices — including complex, permanently implanted devices such as spinal screw systems,[9] artificial joints and nerve stimulators[10] — are approved based on the determination that they are “substantially equivalent” to products already on the market, usually without any clinical testing to show the devices are safe and effective. This process creates unacceptable risks for patients. Approval safeguards are so deficient that a 2011 report by the Institutes of Medicine recommended that the entire system be scrapped and replaced with a new framework that could ensure safety and effectiveness throughout a device’s life cycle.[11] Such changes could positively transform device regulation and are long overdue.


  5. Give the FDA better tools to remove unsafe drugs from the market.

    The FDA must have the tools to quickly remove unsafe drugs from the market and punish bad actors when problems arise. The agency currently lacks two very basic powers for effectiveness in these areas: the authority to require a drug recall and the power to issue civil fines for most drug-related regulatory violations.

    The FDA can issue civil fines for tobacco violations, and it can require recalls for medical devices, biological products (such as blood, blood components and human tissue), tobacco, infant formula and food — but not for drugs.[12],[13] Instead, the agency does most of its policing of drug manufacturers by making requests, issuing warning letters, withdrawing marketing approval and, in extreme cases, pursuing criminal fines and jail time (usually when a patient is injured).

    While most drug companies respond well to these strategies, some do not. The power to issue civil fines and require a mandatory recall would be useful in cases where warnings are ineffective and criminal penalties are not appropriate.

    “21st Century Cures” is a title with promise for the future, but what Congress has offered so far seems to be more of the same: faster FDA approval and greater profits for pharmaceutical companies, without assurances that new products will actually serve patients’ needs. Truly innovative strategies, including the five outlined above, should have a bigger focus in the national conversation.

References

[1] Congresswoman Diana DeGette. 21st Century Cures: A bipartisan initiative to accelerate the pace of cures and medical breakthroughs in the 21st century. http://degette.house.gov/21stCenturyCures. Accessed December 30, 2014.

[2] 21st Century Cures discussion document. January 26, 2015. http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/114/Analysis/Cures/20150127-Cures-Discussion-Document.pdf. Accessed March 3, 2015.

[3] European Medicines Agency. European Medicines Agency agrees policy on publication of clinical trial data with more user-friendly amendments. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/06/news_detail_002124.jsp&mid=WC0b01ac058004d5c1. Accessed December 30, 2014.

[4] 21st Century Cures discussion document. January 26, 2015. http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/114/Analysis/Cures/20150127-Cures-Discussion-Document.pdf. Accessed March 3, 2015.

[5] Food and Drug Administration. Guidance for industry: Format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications (Draft Guidance). September 2009. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm184128.pdf. Accessed December 30, 2014.

[6] Congresswoman Diana DeGette. DeGette calls for new incentives to spur drug innovation. June 11, 2014. http://degette.house.gov/media-center/press-releases/degette-calls-for-new-incentives-to-spur-drug-innovation. Accessed December 30, 2014.

[7] Testimony of Kevin Outterson, Boston University School of Law, to the House Energy and Commerce Committee, September 19, 2014. http://docs.house.gov/meetings/IF/IF14/20140919/102692/HHRG-113-IF14-Wstate-OuttersonK-20140919.pdf

[8] Longitude Prize 2014. http://longitudeprize.org/. Accessed December 30, 2014.

[9] 21 CFR § 888.3070.

[10] 21 CFR § 882.5870.

[11] Institute of Medicine. Medical devices and the public’s health: The FDA 510(K) clearance process at 35 years. National Academy of Sciences; 2011. (Brian Wolfman, former director of Public Citizen’s Litigation Group, served on the committee that oversaw production of the IOM report.) A brief summary of the highlights of this report is available here: http://www.iom.edu/~/media/Files/Report%20Files/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years/510k%20Clearance%20Process%202011%20Report%20Brief.pdf

[12] Congressional Research Service. The FDA’s authority to recall products. August 4, 2010. http://new.nationalaglawcenter.org/wp-content/uploads/assets/crs/RL34167.pdf. Accessed December 30, 2014.

[13] Food Safety Modernization Act. Public Law 111-353. http://www.gpo.gov/fdsys/pkg/PLAW-111publ353/pdf/PLAW-111publ353.pdf. Accessed December 30, 2014.

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