FDA user fee reauthorizations turn into rare bipartisan lovefest at House hearing
Leaving any hint of partisanship to the dust, the subcommittee on health of the House’s energy and commerce committee came together across both sides of the aisle to support not only the user fee reauthorizations that provide for the majority of FDA’s budget, but also the add-on bills that would reform the agency’s accelerated approval pathway among other measures.
On the accelerated approval front, the bill, which advanced to the full committee next week by a unanimous vote of 30-0, would allow the FDA to require confirmatory trials to be underway prior to granting these approvals as part of reforms to shore up companies that drag their feet on such trials. It would also streamline the FDA’s ability to withdraw accelerated approvals when confirmatory trials fail, and it requires the agency to explain itself when not requiring a confirmatory trial.
Kicking off with an upbeat tone at Wednesday’s markup, subcommittee chair Anna Eshoo (D-CA) said that the House can pass these user fee reauthorizations and the additional bills “with plenty time” before the final September deadline.
Like colleagues on both side of the aisle, Eshoo praised the clinical trial diversity rider provisions in the bill, as well as others that the FDA needs to catch up with its 2-year inspection backlog, and on leveling the playing field for US and foreign inspections.
However, one of the few groups taking issue with the current riders in the House is the industry lobbying group PhRMA.
“As the legislation moves forward, it is important that the integrity of the reauthorization of these critical programs not be undermined by the inclusion of extraneous policies that would slow the reauthorization process and jeopardize the US Food and Drug Administration’s (FDA) timely review and approval of critical new medicines,” PhRMA said in a statement.
But other than some questions Eshoo raised about a provision that would also reverse a decision from a hotly-contested court case, Republicans and Democrats spent nearly all of their time praising the various benefits of the provisions included in the bill.
For instance, Rep. Angie Craig (D-MN) praised one new rider that will allow a generic drug to be approved even if its proposed labeling differs from that of the brand drug (previously not allowed).
Republicans’ top member on the subcommittee, Brett Guthrie, (KY) said he looks “forward to make sure this gets signed into law” as it will help the US supply chain, increase biopharma innovation and help those with unmet needs. While pledging more cures will come to market sooner and at lower costs, he also praised the inclusion of the bill’s requirement that FDA issue further guidance on how RWE can help get more drugs approved, Guthrie said.
Rep. Cathy McMorris Rodgers (R-WA) also offered her support for the bill, saying that it will push FDA to embrace change and use novel ways to develop drugs instead of animal models.
Chair of the full E&C committee Rep. Frank Pallone (D-NJ) also said the committee wants to move quickly so the FDA doesn’t have to send out pink slips when the industry funds dry up.
He also noted that while Cures 2.0 was not a part of today’s markup, he’s pleased with the progress on several of the priorities. He also noted that today’s bill includes provisions “on shared priorities such as advancing real world evidence, developing endpoints for rare diseases, and increasing diversity in clinical trials. We are also going to continue to seek technical assistance from the Administration and work on a bipartisan basis to advance the rest of the CURES 2.0 legislation.”