Patient, Consumer, and Public Health Coalition Letter to Senate HELP on the Updated Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA)

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 write to express our appreciation for your efforts to reauthorize the Food and Drug Administration (FDA) user fee programs. Members of our Coalition submitted written comments and feedback regarding your discussion draft for the Food and Drug Administration Safety and Landmark Advancement Act of 2022. While pleased with many of the changes in the updated bill introduced on May 26, we continue to have serious concerns regarding a number of provisions, including: lack of sufficient post-market surveillance of medical devices; several weaknesses regarding accelerated approval reform; lack of bill language to improve the diversity of patients in clinical trials used as the basis of FDA approval decisions; and the lack of post-market surveillance activities in the VALID Act. As you continue your work on this legislation in the Senate as well as with Chairman Pallone and Ranking Member Rodgers, we strongly urge you to take the following comments and recommendations into consideration.

Medical Device Post-Market Surveillance

The legislation continues to fail to provide any funding or requirements to improve post-market surveillance of medical devices, such as support for the analyses of adverse event reports or notifying physicians and patients about Class I recalls. These omissions place 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 has found   rarely requires evidence of safety or effectiveness.1 While the highest risk devices are required to submit clinical data to the FDA, 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 are not implemented or completed as “required” by the FDA. Since user fees are speeding up the approval and clearance of medical devices, user fees should also be required to help 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. It is imperative that you act now to ensure adequate monitoring of medical devices, which have become more and more complex.

Accelerated Approval Reform

We were very pleased to see language included in the updated bill to improve the accelerated approval pathway and hold companies accountable. This reform is critical given the number of drugs that have continued to be prescribed for years after failing to confirm that they are effective, as well as a recent study that showed the median price for accelerated approval drugs was over $168,000 per patient per year (more than 7 times the cost of other newly approved drugs).2 We appreciate the inclusion of language to allow the Secretary to require that drug applicants demonstrate that post-market confirmatory studies are underway prior to granting approval; however, this language should specify that the Secretary “shall” impose these requirements, rather than “may.”  It is even more problematic that the Secretary may waive any requirement for post-market studies for accelerated approval. Post-market studies that require evidence of clinically meaningful outcomes are essential because accelerated approval is often based on short-term surrogate end points that do not necessarily benefit patients’ survival or quality of life, such as tumor shrinkage during the first months of treatment. We oppose allowing real-world evidence to replace clinical trial confirmatory studies; real world evidence can be helpful in augmenting clinical trial data but should not replace it. We also have concerns regarding the members and composition of the Council, some of whom are responsible for previous controversial approval decisions.

Clinical Trial Diversity

We continue to have concerns that the Senate bill fails to include any provisions to address the issue of clinical trial diversity. The bill that was voted on and passed unanimously out of the House Energy and Commerce Committee included provisions to improve clinical trial diversity. We have seen numerous examples of patients being seriously harmed when diversity is not addressed. For example, a recent study of pulse oximetry devices among patients with COVID-19 found that these devices worked poorly for individuals with darker skin, resulting in inaccurate oxygen readings, delayed treatment, and higher COVID-19 mortality rates in people of color. Diversity must be addressed throughout the span of product development, including data submitted to the FDA for applications for approval.

VALID Act

We appreciate the overall improvements to the VALID Act, specifically regarding post-market surveillance activities and authorities. The bill makes use of newly articulated postmarket authorities and preserves FDA’s ability to invoke other currently available authorities if needed. However, the resources section of this bill contains several provisions that could hamper FDA’s ability to carry out this important work in the long term. In particular, it would not allow FDA to apply user fees to postmarket activities—and since most tests won’t be reviewed premarket, this would create an insurmountable barrier to the agency’s enforcement of the statute. We strongly recommend you allow user fees to be used for postmarket activities to ensure patients and consumers are safe from unreliable and inaccurate diagnostic tests.

The five-year cycle to reauthorize the FDA user fee programs provides you and all Members of Congress with the responsibility to review the current operations at this essential public health agency and set the course for the next five years. We respectfully urge you to act now to address known deficiencies and protect all patients and consumers from harmful and ineffective medical products.

Please contact Thomas Eagen (te@center4research.org) at the National Center for Health Research with any questions.

 

Sincerely,

American Medical Student Association (University of Wisconsin chapter)

Breast Implant Safety Alliance

DES Action USA

Doctors for America

Jacobs Institute for Women’s Health

Medical Device Problems

MedShadow Foundation

Mothers Against Medical Error

MRSA Survivors Network

MISSD

National Center for Health Research

National Women’s Health Network

Patient Safety Action Network

The Society for Patient Centered Orthopedics

TMJ Association

USA Patient Network

U.S. PIRG

Washington Advocates for Patient Safety

Woodymatters

  1. 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.
  2. Rome, B., Egilman, A. & Kesselheim, A. (2022). Trends in Prescription Drug Launch Prices, 200802921. JAMA, 327(21), 2145-2147.