- Top Senate Democrats are pressing FDA to explain a recent budget proposal that seeks to grant the agency a two-step approval for medical devices for life-threatening conditions despite former Commissioner Scott Gottlieb's stance such stepwise approval is inappropriate for human medical products.
- Expanding a conditional approval framework to medical devices does not align with FDA's Medical Device Safety Action Plan, Massachusetts Sen. Elizabeth Warren and HELP Committee Ranking Member Patty Murray of Washington wrote in a recent letter to the agency. The two senators said they have "serious concerns" with the proposed progressive approval program for devices.
- An FDA spokesperson told MedTech Dive the proposal was cleared by Gottlieb, FDA's medical product centers, HHS and the Trump administration prior to being published in the agency's budget justification.
The agency "will be responding directly" to the senators, according to FDA spokesperson Allison Hunt, but it is unclear if it will meet the July 8 deadline. A Murray spokesperson told MedTech Dive Monday the office has not yet received a response from FDA.
Hunt said the proposal would maintain appropriate safeguards for patient safety, noting a conditional approval would automatically sunset if data assuring a "reasonable assurance of safety and effectiveness" is not gathered during the interim approval phase.
"FDA cleared this proposal because Progressive Approval would provide a new lifeline between patients and promising technology under a controlled infrastructure with safeguards and oversight," Hunt said in an email.
But Warren and Murray raised concern FDA's plan to include an automatic sunset for a device's approval under the proposed program would not comply with requirements of procedural due process.
During negotiations over animal drug user fee legislation in July 2018, Gottlieb and FDA Center for Veterinary Medicine Director Steve Solomon wrote to HELP Committee Chairman Lamar Alexander, R-Tenn., and Murray assuring the lawmakers a proposal for conditional approval for animal drugs is not "suitable for human medical products."
"We were very clear that we thought this was a construct that made sense in the context of animal drugs," Gottlieb told MedTech Dive after his final testimony to Congress in April. "It wouldn't make sense in other product areas. We're not looking to do that, that's a concept that was narrowly tailored for the purpose of animal drug approvals."
Warren and Murray wrote they strongly object to any expansion of the conditional approval pathways under the Animal Drug User Fee Act to human medical products. The senators asked FDA to explain if the agency stands behind Gottlieb's statement that conditional approval for animal drugs is not suitable for human medical products. "If not, please explain why not," they wrote.
"As written, this 'provisional approval' seems hardly distinguishable from the 'conditional approval" that former-Commissioner Gottlieb had assured Congress and the public that the FDA 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."
In their letter, the senators also requested FDA to provide details on what staff were involved with the decision to include the progressive approval program in the budget proposal, including a request for "a list of any and all outside organizations or individuals who contacted or were contacted by FDA."