House committee unanimously advances FDA user fee legislation with accelerated approval tweaks
The House Energy and Commerce Committee on Wednesday offered a rare show of bipartisan support for a bill that would provide the FDA with user fees for the next five years.
The committee voted 55-0 to advance the quinquennial user fee bill to the full House floor, which if approved, will allow the FDA to use biopharma funds to hire new reviewers, and hit new marks as outlined in the user fee deals that the FDA and biopharma companies forged over the past several years.
While the reauthorization of these fees usually sticks to just the FDA-industry agreements, the bill that advanced out of the House committee on Wednesday features multiple new provisions, including accelerated approval reforms, manufacturing inspection tweaks at the FDA, and others.
On the accelerated approvals, committee chair Frank Pallone (D-NJ) said at the markup Wednesday that he heard from FDA officials that some drugs approved via the accelerated pathway take years to start their confirmatory trials, and if the sponsor fails to show benefit, it can take even more time to pull the drugs from the market.
Examples of both scenarios can be seen with Sarepta’s DMD drug eteplirsen, which took almost 4 years to begin its confirmatory trial after its accelerated approval, and the controversial preterm birth drug Makena, which the FDA is still trying to pull from the market after its failed trial in 2018.
But the Senate draft of its own user fee bill, unveiled yesterday, did not include many of these same provisions like the accelerated approval reforms, and instead looks to ramp up FDA regulation of cosmetics, nutritional supplements, and in vitro diagnostics.
Both Indiana Republican Larry Bucshon and Colorado Democrat Diana DeGette said Wednesday that they’re pleased to see the Senate included the VALID Act in its user fee reauth bill, but DeGette said she would prefer to work with Pallone to include this diagnostic testing regulation into the House bill.
“The time is now to answer the call and address the pitfalls that exist in the current regulatory framework surrounding laboratory developed tests,” Bucshon said.
Without revealing whether he would budge on LDTs, Pallone responded with, “Whenever the Senate takes action on anything, we have to take notice.”