FDA User Fee Bill Deadline Passes; FDA Reviewers May Be Laid Off

FDA User Fee Bill Deadline Passes; FDA Reviewers May Be Laid Off

July 17th, 2022 // 6:54 pm @

The fight over what should be included in the latest round of FDA user fee legislation – the money from the pharma industry that pays for drug and biologic reviews at the agency that must be reauthorized every five years – is reaching a climax this month.

Congress is attempting to meet a recess deadline for August before the agency has to send warnings to thousands of drug reviewers that they may be laid off this year. Not only would FDA have to fire these employees; all PDUFA deadlines would be dead in the water as FDA wouldn’t have the staff onhand to meet the required deadlines.

North Carolina Republican and Senate health committee ranking member Richard Burr last week introduced a new and blank version of the legislation as a way to start over without any policy riders that got out of the congressional committee. One of them was the accelerated pathway approval updates that would allow the agency to require drug companies to start postmarketing safety studies before doing the sped-up drug approvals.

Burr told the media that the user fee package that came out of the committee would undermine the idea of the user fee bill. The policies in the bill, Burr said, risk the development of pharmaceuticals for rare diseases and could threaten citizens’ access to innovative cures and treatments.

Senate health committee chair Patty Murray (D-WA) responded that laying off FDA workers is unacceptable to her and the committee shouldn’t back out of the negotiations now.

Burr, who is not up for reelection this year, has said during the user fee legislation reauthorization process that Congress may not be able to meet the deadline at the end of September that are needed to keep user fees going for drugs, generics and medical devices.

However, some industry experts think the reauthorization bill will proceed on schedule. After all, this is legislation that must pass, and it’s understood that the members on the committee are usually responsible to deadlines.

That said, there are major gaps between the bills that have come out of the House and Senate. The House version has new clinical trial diversity directives, and the Senate version contains things FDA could do to better regulate dietary supplements and cosmetics.

FDA commissioner Rob Califf recently said that getting the user fee bill reauthorization is very important.

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