'Practically clean' FDA user fees reauth will be included in spending bill wrapping up next week
The long and winding road to reauthorizing FDA’s quinquennial user fees for prescription drugs, generics, biosimilars and medical devices finally has a light at the end of it.
While negotiations are still ongoing on which policy riders (accelerated approval reforms, et. al.) may be included, a senior GOP committee aide confirmed to Endpoints News Thursday that at the very least, an agreement has been reached for the FDA user fee deals, which are good through 2027, to be included in the continuing resolution.
An aide to Sen. Patty Murray (D-WA), the chair of the Senate Health Committee, told Endpoints via email:
Senator Murray has reached a deal on a practically clean reauthorization that ensures Congressional inaction won’t force FDA to send out pink slips along with some additional policies. But even after we have addressed this immediate challenge before the looming deadline she believes we can’t, and she won’t, stop pushing for the kind of reforms families need to see from the drug industry and this critical agency.
That CR, or short-term spending bill to keep the government going, needs to get done by the end of next week, and some of the pieces to that puzzle are finally moving forward.
While FDA commissioner Rob Califf has remained confident that such a deal would emerge, the agency previously noted that if Congress doesn’t follow through on its promises, ongoing PDUFA dates would disappear, and, “More than 3,500 PDUFA-funded employees would be impacted, leaving fewer than 1,000 full-time employees at CDER and half that many at CBER,” an FDA spokesperson said.
A PhRMA spokesperson also offered a sigh of relief, telling Endpoints that it’s encouraging to see movement towards getting this done before Sept. 30. There were prior discussions that the FDA might have to dip into reserve funds to keep operations and drug reviews going for another month or so.
