In a recent letter to US Food and Drug Administration (FDA) officials, Sens. Elizabeth Warren (D-MA) and Patty Murray (D-WA) opposed the idea of FDA’s using a conditional approval pathway for medical devices.
The 24 June letter questions the “progressive approval for devices” FDA described in its budget justification
for Fiscal Year 2020. The senators argue that FDA’s proposal seems to expand the conditional approval pathway available for certain animal drugs to also include human medical products.
in a July 2018 letter that it “believes conditional approval offers a unique pathway to address specific challenges of certain aspects of veterinary medicine that human medicine does not face” so, the agency “does not believe this pathway would be suitable for human medical products.” The senators cite this letter in questioning whether FDA stands by its commitments.
“We strongly oppose the expansion of the conditional approval pathway to human drugs and devices, and we are seeking clarification on whether the FDA is pursuing this policy despite then-Commissioner Gottlieb's commitments to the contrary,” Warren and Murray write
The senators also cite media reports
where Gottlieb reaffirmed the intention not to expand the conditional approval approach to other product areas, while Center for Devices and Radiological Health (CDRH) Director Jeff Shuren touted leveraging additional postmarket data via such a pathway.
FDA has been exploring ways to expand access to devices through different mechanisms. These include the Breakthrough Device Program’s expansion
and the creation
pathways. Yet whether FDA is now pursuing a policy on provisional, conditional or progressive approval of devices remains unclear.
The provisional approval description in the agency’s budget justification “seems hardly distinguishable from the ‘conditional approval’ that then-former Commissioner Gottlieb has assured Congress and the public that the FDA would not pursue,” the senators say. “Whether ‘progressive,’ ‘provisional,’ or ‘conditional,’ the proposal is particularly alarming given the FDA’s already-lenient regulatory framework guiding medical device effectiveness,” the senators add.
With an 8 July deadline, the senators pose six questions to FDA Acting Commissioner Ned Sharpless and Shuren. The senators ask whether FDA stands by its July 2018 commitments, if there is a difference between “progressive approval” and “conditional approval” and if the proposed approach to sunset approval complies with due process requirements. They request a list of contacts used to develop a progressive approval program for devices as well as updates on FDA efforts to implement such a program, including relevant new policies and procedures.