May 22, 2022
The Honorable Patty Murray
Chair, Committee on Health, Education, Labor and Pensions
United States Senate
428 Dirksen Senate Office Building
Washington, DC 20510
The Honorable Richard Burr
Ranking Member, Committee on Health, Education, Labor and Pensions
United States Senate
428 Hart Senate Office Building
Washington, DC 20510
Dear Chair Murray and Ranking Member Burr,
As members of the Patient, Consumer, and Public Health Coalition, we appreciate the opportunity to submit comments and feedback on the draft legislation, the Food and Drug Administration Safety and Landmark Advancement Act of 2022, which will reauthorize the Food and Drug Administration (FDA) user fee programs. We thank you for your hard work on this critical piece of legislation. We support your efforts to improve the safety of cosmetic products. In addition, we strongly urge you to include the recommendations below to further strengthen the bill and ensure the medical products approved by the FDA are safe and effective for all patients and consumers.
- Accelerated Approval – Reform to the accelerated approval pathway must be included in the final legislation. Too often, drug manufacturers are granted approval based solely on surrogate endpoints and fail to complete confirmatory trials demonstrating clinical effectiveness. Any reform to this pathway should include the mandatory requirement that confirmatory trials provide proof of meaningful clinical benefit and manufacturers provide evidence of active enrollment of patients in post-market confirmatory trials prior to granting approval. Reforms should also include provisions to give the FDA authority to quickly remove ineffective or unsafe drugs from the market, rather than relying on manufacturers to do this voluntarily.
- Post-market surveillance of medical devices – The current draft of the legislation fails to provide any post-market surveillance of medical devices. This omission places patients at an increased risk of being harmed by unsafe or ineffective devices. The vast majority of regulated medical devices continue to be approved through the 510(k) pathway, which research shows, rarely requires evidence of safety or effectiveness.1 While the highest risk devices are required to submit clinical data, these are rarely randomized trials, often lack appropriate comparison groups, and are almost never blinded. When post-market studies are mandated, they are often delayed and, in many cases, not implemented or completed as “required” by the FDA. User fees should be used to ensure the FDA has the resources needed to improve oversight of post-market surveillance, such as clinical trials, adverse event monitoring, implementation and notification of the public of device recalls, and facility inspections.
- VALID Act – We strongly support the inclusion of the VALID Act and the regulation of lab-developed diagnostic tests in the final user fee legislation, however we have a number of concerns with provisions in the current draft to ensure these tests are accurate. As currently drafted, approximately 100,000 tests would be grandfathered in and exempted from review. The developers would not be required to submit evidence demonstrating the clinical and analytical validity of their tests, regardless of the risk to patients from an inaccurate result. Additionally, we are very concerned about the definitions of low, moderate, and high risk tests, with the low risk category being very expansive and the high risk category being overly restrictive, apparently excluding many genetic tests. Finally, the draft legislation fails to provide any additional resources to the FDA to support the regulation of these tests. Without adequate resources, the FDA will be unable to successfully implement these provisions, resulting in the down classification of tests to reduce burden on the FDA staff.
- Clinical trial diversity – The draft legislation fails to include any provisions to increase clinical trial diversity. A recent report from the National Academies of Sciences, Engineering and Medicine found current voluntary efforts to improve clinical trial diversity have failed across Health and Human Services (HHS) agencies.2 The final legislation must include enforceable provisions to increase diversity in clinical trials to ensure medical products approved by the FDA are safe and effective for all patients.
We look forward to continuing to work with you and your staff to improve the Food and Drug Administration Safety and Landmark Advancement Act of 2022. Please contact Thomas Eagen (te@center4research.org) at the National Center for Health Research with any questions or to discuss these recommendations in more detail.
Sincerely,
American Medical Student Association (University of Wisconsin chapter)
Breast Cancer Action
Breast Implant Safety Alliance
DES Action
Doctors for America
Jacobs Institute of Women’s Health
Medical Device Problems
MedShadow Foundation
MISSD
Mothers Against Medical Error
MRSA Survivors Network
National Center for Health Research
National Women’s Health Network
Our Bodies Ourselves
Patient Safety Action Network
SCAD Alliance (Spontaneous Coronary Artery Dissection)
TMJ Association
USA Patient Network
Washington Advocates for Patient Safety
Woodymatters
- 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.
- National Academies of Sciences, Engineering and Medicine (2022). Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups.