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Senators question proposed device approval changes

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CREDIT: This post was originally published on this site

U.S. Senators Patti Murray (left) and Elizabeth Warren

U.S. Senators Patti Murray (D-Wash.) and Elizabeth Warren (D-Mass.) are challenging an FDA budget proposal that would ease the approval process for certain medical devices.

In a June 24 letter to Acting Commissioner Dr. Ned Sharpless and Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health, Murray and Warren target the “progressive approval for devices” program included in the agency’s fiscal year 2020 budget that would expand the conditional approval pathway for animal drugs to human medical products. Former FDA Commissioner Scott Gottlieb had “assured us” this expansion would not take place, the senators wrote.

“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,” the letter says.

The FDA established the conditional approval pathway for animal drug development in 2004, allowing drugs for “minor species” or for “minor uses in a major species” to bypass the traditional FDA approval process without fully demonstrating their effectiveness. They have five years to meet the “substantial evidence” of effectiveness standard.

In August 2018, the Animal Drug User Fee Act (ADUFA) further expanded the conditional approval pathway by creating a 10-year pilot program that allows other animal drugs to qualify, as long as the drug is “intended to treat a serious or life-threatening disease or addresses an unmet animal or human health need and for which the Secretary determines that a demonstration of effectiveness would require a complex or particularly difficult study or studies.”

“We strongly objected to any expansion of the conditional approval pathways in ADUFA that would have applied to human medical products, and we remain committed to ensuring that the FDA does not extend this approval pathway to human drugs or medical devices,” the senators wrote.

The FDA’s FY 2020 budget proposal includes references a proposed “progressive approval for devices” that would allow certain devices to ”be eligible for provisional approval based on a demonstration of safety and performance plus additional risk mitigations.” Devices approved this way could remain on the market “after an established tin1e period only after a demonstration of reasonable assurance of safety and effectiveness.”

The provisional approval process seems “hardly distinguishable” from the conditional approval that Gottlieb said the agency would not pursue, the senators wrote. “Whether ‘progressive,’ ‘provisional’ or ‘conditional,’ the proposal is particularly alarming, given the FDA’s already-lenient regulatory framework guiding medical device approval standards. While new drug sponsors must show “substantial evidence” of effectiveness, new device sponsors must only show a “reasonable assurance of … safety and effectiveness.”

Shuren has long advocated for the expansion of approval pathways and has indicated that provisional and conditional approval are the same, the senators added. Warren and Murray, a ranking member of the Senate Committee on Health, Education, Labor, and Pensions, asked Sharpless and Shuren to respond to their general concerns and to specific questions by July 8.

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