June 25, 2019

Senators Warren, Murray Question FDA Proposal to Weaken Approval Standards for Medical Devices


Text of the Letter (PDF) | July 2018 Letter from Gottlieb (PDF)


Washington, DC - United States Senators Elizabeth Warren (D-Mass.) and Patty Murray (D-Wash.), Ranking Member of the Senate Committee on Health, Education, Labor, and Pensions, sent a letter to Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless and Center for Devices and Radiological Health Director Jeffrey Shuren questioning whether the FDA has plans to weaken approval standards for medical products—a change that former FDA Commissioner Scott Gottlieb said would not take place.


Senators Warren and Murray are raising these questions after identifying language included in the FDA’s Fiscal Year 2020 budget justification that references an FDA proposal called “progressive approval for devices.” According to the budget justification, this proposal would allow certain medical devices to initially “be eligible for provisional approval based on a demonstration of safety and performance plus additional risk mitigations.” Devices awarded “provisional approval” could then “remain on the market after an established time period only after a demonstration of reasonable assurance of safety and effectiveness.” This language indicates that the FDA is considering making standards for medical devices more lenient by allowing the marketing of devices that have not met FDA’s gold standard for safety and effectiveness.


This proposal appears strikingly similar to the “conditional approval” pathway available to manufacturers of certain animal drugs, which former Commissioner Gottlieb assured senators would not be expanded to human medical products. As written, the proposal appears to directly contradict former Commissioner Gottlieb’s assertions that the FDA’s “conditional approval” pathway for animal drugs “wouldn’t make sense in other product areas” and would “not…be suitable for human medical products.”


This news is especially alarming, given the FDA’s already-lenient regulatory framework for medical devices.


“Assuring patient safety and device effectiveness must be the primary goal of any approval system managed by the FDA,” wrote the lawmakers. “[Lowering standards for] medical devices, however, does not align with the critical goal of keeping Americans safe from harm.”


The lawmakers requested assurances that the FDA intends to uphold former Commissioner Gottlieb’s commitment to medical device safety, and requested clarification on what actions the FDA intends to take with its “progressive approval for devices” proposal no later than July 8, 2019.