FDA User Fee Reauthorizations Supported By Both Sides Of The Aisle On Capitol Hill

FDA User Fee Reauthorizations Supported By Both Sides Of The Aisle On Capitol Hill

May 12th, 2022 // 2:22 pm @

The subcommittee on health in the House’s energy and commerce committee made an agreement across the aisle this week to not just stay behind user fee reauthorization that give the FDA most of its annual budget. They also supported various add-on bills that would improve FDA’s accelerated approval steps for new drugs.

Regarding accelerated product approvals, the bill would let the agency require confirmatory clinical trials to be going before allowing those drug approvals as part of new reforms to support companies that delay these critical trials. This also would improve FDA’s ability to pull accelerated approvals if the confirmatory trial fails. It also requires FDA to explain itself when it does not mandate a confirmatory trial.

Subcommittee chair Anna Eshoo (D-CA) said the House of Representatives can easily pass the user fee reauthorization and the other bills with ample time before the deadline in the fall.

Eshoo had good things to say about the clinical research diversity riders in the bill, as well as others encouraging FDA to catch up on its cGMP inspection backlog going back two years from the pandemic.

However, the powerful industry lobbying group PhRMA took issue with some of the riders in the bill. They said as the legislation proceeds, it’s vital for the integrity of reauthorization of these programs that they are not diluted by less important process that would delay the reauthorization process and slow the ability of FDA to review and approve new drugs.

But there were a lot of positive comments from both parties on the bill’s provisions. One is a rider that allows a generic medicine to be approved even if the proposed label is different from the brand drug. This wasn’t allowed before.

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