- The Food and Drug Administration could require drugmakers seeking speedy approvals of new treatments to begin confirmatory testing before gaining the agency’s clearance under legislation before Congress. Released Tuesday, the legislation would also expedite the process for withdrawing conditionally approved drugs.
- Contained in a massive, year-end federal spending bill, the provisions instruct the FDA to convene a seven-member council of agency officials to develop consistent policies and practices around accelerated approvals.
- The FDA has been under pressure over accelerated approvals, as numerous drugs cleared via the program haven’t been confirmed to benefit patients in follow-up testing. Withdrawing products that don’t can be a lengthy process, too, as demonstrated by the back-and-forth over Covis Pharma’s preterm birth drug Makena. The agency also used a conditional approval to controversially clear Biogen’s Alzheimer’s treatment Aduhelm.
The spending bill is expected to face votes first in the Senate and then in the House later this week.
Some lawmakers pushed reforms to the accelerated review process throughout the year, intending for them to be included in a five-year bill reauthorizing the FDA’s powers to collect funding from industry. Those provisions were left out of the final bill that President Joe Biden signed in September, however.
Under the language included in the so-called “omnibus” spending bill, the FDA will have the power to specify the design of confirmatory trials, and drugmakers will be required to report every 180 days on their progress toward completion of the confirmatory trials.
These provisions could help prevent “dangling” accelerated approvals, which describes drugs that remain on the market under conditional clearances for years without confirmatory proof they work.
Mandatory withdrawals following failed trials, a rarely used tool, could also be faster under the legislation. The bill lays out a procedure for notice and public comment on withdrawals, meetings with the FDA and opportunities for companies to appeal and ask for a meeting of outside advisers.
The current withdrawal pathway, by comparison, is long and cumbersome. Makena is still on the market four years after a failed trial, and could be on for months more as agency officials review an advisory committee vote in favor of withdrawal.
The accelerated approval advisory council, meanwhile, would be made up of the directors of FDA’s major drug review centers, and would meet at least three times a year to develop policy as well as provide guidance to agency staff.
This legislation doesn’t include some tougher rules on accelerated approvals that were proposed in Congress. For example, Rep. Frank Pallone (D-N.J.) put forward legislation that would have sunset all accelerated approvals after five years.