November 05, 2019

Senators Warren and Murray Raise New Questions About FDA Proposal to Weaken Approval Pathway for Certain Medical Devices

Lawmakers are concerned with how the FDA plans to maintain device safety and efficacy, particularly as the FDA cites device needs for children’s health as justification for the proposal

Boston, MA - United States Senator Elizabeth Warren (D-Mass.), member of the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee and U.S. Senate HELP Committee Ranking Member Patty Murray (D-Wash.) sent a letter to Acting Food and Drug Administration (FDA) Commissioner Brett Giroir and FDA Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren calling for clarity and raising new concerns about the agency’s legislative proposal for a “progressive approval” pathway for medical devices.

In July 2018, then-FDA Commissioner Scott Gottlieb committed that the agency would not expand to human medical products the “conditional approval” pathway currently available to manufacturers of certain animal drugs. The conditional approval pathway allows manufacturers to make certain animal drugs available after demonstrating a “reasonable expectation of effectiveness” rather than the higher “substantial evidence of effectiveness” standard required for full drug approval. But in April 2019, the FDA proposed the creation of a progressive approval pathway for medical devices, which appeared strikingly similar to the conditional approval pathway. Progressive approval would weaken initial approval standards and allow certain medical devices onto the market before manufacturers completely demonstrated the device’s safety and effectiveness, potentially placing the American public at risk.

In June 2019, Senators Warren and Murray opposed this proposal and requested the FDA clarify its stance. In its August 2019 response to the lawmakers, released publicly today, the FDA stated that while it “continues to believe that such a [conditional approval] pathway would be unsuitable for human drugs and biologics,” the agency’s views on medical device oversight “have continued to evolve.” The FDA cited the unmet needs for children’s medical devices in justifying the agency’s proposal for progressive approval. In the new letter released today, Senators Warren and Murray raise further questions about how the FDA’s new proposal would actually address these needs while maintaining FDA’s safety and efficacy standards for medical devices.

“We are disappointed by FDA’s clarification that the agency no longer fully stands by former-Commissioner Gottlieb’s commitment that the ‘FDA does not believe this…pathway would be suitable for human medical products,’” wrote the lawmakers. “[W]e continue to have questions regarding the eligibility criteria the FDA envisions for this proposal; the FDA’s ability to ensure the quality and completeness of post-market data collection; and the agency’s ability to exercise its authority to remove medical products from the market once they have been approved under an accelerated approval pathway.”

The lawmakers’ letter asks a series of follow-up questions requesting detailed information about the FDA’s intentions with the pathway, and requested responses no later than November 13, 2019.