The Honorable Patty Murray The Honorable Richard Burr
Chair Ranking Member
Senate Health, Education, Senate Health, Education,
Labor & Pensions Committee Labor & Pensions Committee
Washington, DC 20515 Washington, DC 20515
The Honorable Frank Pallone The Honorable Cathy McMorris Rodgers
Chair Ranking Member
House Energy & Commerce Committee House Energy & Commerce Committee
Washington, DC 20515 Washington, DC 20515
Dear Chair Murray, Ranking Member Burr, Chair Pallone, and Ranking Member Rodgers:
As members of the Patient, Consumer, and Public Health Coalition, we write to urge you to expeditiously consolidate the two pieces of legislation to reauthorize the Food and Drug Administration (FDA) user fee programs for medical products. This includes the Food and Drug Amendments Act of 2022 (H.R. 7667), which passed the House of Representatives on June 8, and the Food and Drug Administration Safety and Landmark Advancements Act (S. 4348), which passed the Senate Health, Education, Labor, and Pensions (HELP) Committee on June 15. In 2021, the user fee programs accounted for approximately 65%, 42%, and 35% of the FDA budget for review and regulation of drugs, biologics, and devices, respectively.1 As you know, it is critically important for Congress to act quickly as the current programs will expire at the end of the current fiscal year.
There are significant differences between H.R. 7667 and S. 4348 with respect to policies added in addition to the user fee program reauthorization. This includes reform to the accelerated approval pathway, clinical trial diversity, and new oversight of dietary supplements, cosmetics, and lab-developed diagnostic tests. As you consider how to reconcile these differences to provide FDA with the tools, authorities, and resources needed to keep patients and consumers safe, while also ensuring medical products are able to reach patients quickly, we request your consideration of the following comments and recommendations.
We appreciate the efforts from both chambers to reform the accelerated approval program. While this is an important pathway for new drug development, there is a need for safeguards to keep patients protected from harmful and possibly ineffective treatments. A recent article published in JAMA found that the average launch price of accelerated approval drugs in the last two decades was $168,344 per person per year, compared to only $12,912 for other newly approved drugs.2 This makes it even more urgent to ensure the pathway is not abused and every step is taken to guarantee the drugs are safe and effective for patients. We agree with the approach of the two bills to require post-market studies to be underway prior to approval being granted. However, we have concerns regarding the roles and responsibilities of the Accelerated Approval Council included in S. 4348 sec. 506(f). Several of the individuals who would serve on the Council have had a major role regarding the accelerated approval program during the time where numerous cancer drugs retained approval for years after it was clear that their risks outweighed the unproven benefits. Moreover, several of these same FDA officials were responsible for controversial approvals counter to recommendations from advisory committee members (i.e., Aduhelm). There is no reason to believe that codifying their role would improve the accelerated approval program. We therefore recommend that you strike the Council provision in the final user fee reauthorization bill.
Clinical trial diversity
We support the provisions included in H.R. 7667 to improve clinical trial diversity and recommend inclusion in the final bill. Lack of clinical trial diversity has resulted in the approval of treatments that are ineffective or inaccurate in some populations, further expanding inequities across the healthcare system. A recent congressionally mandated report published from the National Academies of Sciences, Engineering, and Medicine calls for urgent actions to improve representation of racial and ethnic minority groups in trials and research.3 In addition, lack of older patients in many studies used as the basis of FDA approval has resulted in very expensive Medicare coverage for treatments that are unsafe or ineffective for our nation’s elderly. Diversity must be addressed across the product lifespan and the provisions included in H.R. 7667 are an important first step by requiring drug and device manufacturers to submit diversity actions plans. Although, an enforcement mechanism would be needed to ensure goals included in the plans are met.
Lab-developed diagnostic tests
We strongly support several provisions included in S. 4348 to improve the regulation and oversight of lab-developed diagnostic tests. The revised language of the VALID Act in S. 4348 will provide the FDA with the authority and resources necessary to ensure that the highest-risk diagnostic tests are valid and reliable. We have seen the importance of diagnostic tests throughout the COVID-19 pandemic and the potential harm from an inaccurate result. In addition, increasing numbers of patients make life-altering decisions based on diagnostic tests, which can be used to predict cancer or fetal abnormalities. Physicians often incorrectly assume FDA has evaluated all of these diagnostic tests, not realizing that FDA does not regulate lab-developed tests. The provisions of the VALID Act in S. 4348 will help give physicians the necessary assurances that the tests they are using on their patients are accurate. However, it is essential that the definition of high-risk tests include genetic testing that could result in life-altering decisions, and that the provision that would grandfather all lab-developed tests currently on the market would be modified to require vetting of high-risk tests.
Post-market surveillance of medical devices
We are extremely disappointed by the lack of post-market surveillance of medical devices at the FDA, and the fact that neither the House nor Senate bills improve that situation except for lab-developed tests. Millions of Americans have been seriously injured from harmful and ineffective medical devices approved by the FDA. This potential for harm has continued to increase as these devices grow in complexity. Experts estimate that more than 95% of regulated medical devices continue to be cleared for market through the 510(k) pathway, and research has found that FDA rarely requires evidence of safety or effectiveness for that pathway, despite the claim that they do so.4 The House and Senate bills would continue to place patients at risk by specifying that funds collected from device user fees cannot be used for post-market surveillance activities. Rather than focusing on patient safety, the FDA continues to cater to the medical device industry to review devices as quickly as possible by focusing user fee funds only to meet pre-market performance goals, as defined by speed, not safety. None of these funds can be used for post-market surveillance. There must be a better balance between speed and safety. Adverse event reporting systems are outdated and not used in a timely manner. Recall notices are often delayed, and too many patients do not receive critical information about recalled implants and products that their lives depend on. Registries for implanted devices are owned and operated by medical associations, and their safety data are often not made available to the FDA, healthcare professionals, or public health advocates. Technology advances in medical devices have increased the possibility of cybersecurity threats, yet the true impact is unknown. There are numerous post-market surveillance activities that could be greatly improved through the use of user fees. We strongly recommend the inclusion of post-market surveillance activities in the final user fee reauthorization bill as supplemental report language or any other form.
We greatly appreciate the bipartisan efforts on these critical pieces of legislation. We urge you to continue to work together to carefully finalize the reauthorization legislation. It must provide the FDA with the tools and authorities to keep patients and consumers safe while continuing to bring new medical products to the market that are proven to be effective.
American Medical Student Association (University of Wisconsin chapter)
Breast Cancer Action
DES Action USA
Jacobs Institute of Women’s Health
Medical Device Problems
MRSA Survivors Network
National Center for Health Research
National Women’s Health Network
Patient Safety Action Network
The Society for Patient Centered Orthopedics
USA Patient Network
Washington Advocates for Patient Safety
1. Food and Drug Administration (2021). Regulated Products and Facilities. Fact Sheet: FDA at a Glance. https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance
2. Rome, B.N., Egilman, A.C., & Kesselheim, A.S. (2022). Trends in Prescription Drug Launch Prices, 2008-2021. JAMA, 327(21), 2145–2147. doi:10.1001/jama.2022.5542
3. National Academies of Sciences, Engineering, and Medicine. 2022. Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. Washington, DC: The National Academies Press. https://doi.org/10.17226/26479.
4. Zuckerman, D., Brown, P., & Das, A. (2014). Lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices. JAMA Intern Medicine, 174(11), 1781-7. doi: 10.1001/jamainternmed.2014.4193.