Senators grill industry groups over FDA user fee agreements to fund the agency through 2027
Members of the Senate health committee on Tuesday fired off questions at drug industry reps in the first of two hearings to deal with the latest five-year funding agreements that Congress has to re-authorize by the end of September and that the FDA relies on to review new drug, generic drug, biologic and biosimilar applications.
Committee Chair Patty Murray (D-WA) made clear in her opening remarks that the FDA has done a superior job, particularly when it’s come to the pandemic, living up to its “gold standard” tagline, but “FDA doesn’t run on gratitude.”
Now in its seventh iteration, Prescription Drug User Fee Act or PDUFA has morphed into a way to provide additional revenue to the agency so it can hire more staff, improve its systems and establish a better-managed, more reliable review process to make important drugs available to patients sooner.
While the FDA’s remit doesn’t include drug pricing, Murray stressed the need to fight skyrocketing health costs and stop companies from denying generics and biosimilars access to the market.
But on the other side of the aisle, ranking member Richard Burr (R-NC) questioned the need for these ever-expanding user fee agreements, which provide for the majority of the FDA’s total funding. In 1993, he noted, PDUFA was first authorized and included only about $35 million for FDA. Today, the agreement is worth more than $1 billion.
Burr stressed that the FDA has continued to see increases in funding with each new -UFA reauthorization, even as the FDA has struggled to meet certain agreed-to goals, including those around scheduling meetings and staffing up.
Much of this round’s new funding will go toward hiring more FDA staff, Burr noted, and while the FDA is committing to 884 new hires over the next 5 years, the agency still has around 700 vacancies outstanding.
CDER Director Patrizia Cavazzoni yesterday also called on Congress to provide more funds for additional hires after a spike in staff losses last summer.
“The FDA is increasingly removing itself from Congress’ reach and my colleagues should be concerned about this,” Burr said, stressing that the agency should be held accountable for its commitments.
Sens. Tim Kaine (D-VA) and Susan Collins (R-ME) also questioned industry group BIO’s rep regarding the FDA’s plans for a new pilot program to support efficacy endpoint development for rare disease drugs by offering additional engagement opportunities.
BIO CSO Cartier Esham said the pilot will build off work the FDA has done on pilots related to model-informed drug development and complex innovative trial designs, and help the FDA and sponsors connect on what’s needed to support the utilization of a new endpoint.
Meanwhile, Pew’s health care director Liz Richardson told the committee that while her NGO supports the reauthorization of these user fee agreements, the FDA needs more resources to protect public health, and should be accountable to the public, not just the industry it regulates.
Other senators raised smaller, more pointed concerns regarding the FDA’s progress in certain areas.
For instance, Sen. Chris Murphy (D-CT) lamented the lack of new drugs to tackle mental health conditions over the past 8 years, while Sen. Mike Braun (R-IN) called for more of a focus on the patient voice.
David Gaugh, SVP at the generic drug industry group, also explained to Sen. Maggie Hassan (D-NH) how the latest GDUFA will help increase generic drug approvals as it includes a provision that will allow the FDA to take an “imminent action” route so as to avoid issuing a complete response letter when a generic drug could be approved, but the agency may need an additional 60 days to review the app.