FDA says user fees could run through February, as patient orgs raise alarm
- As Food and Drug Administration leaders say they expect to run out of money in weeks to review new prescription drugs, more than 40 patient and research groups have raised alarm to U.S. political leaders that the partial government shutdown's effect on the FDA has begun impacting safety and science.
- FDA Commissioner Scott Gottlieb told an agency town hall meeting Tuesday the U.S. regulator may be able to stretch the timeline on leftover funds from the Prescription Drug User Fees Act, or PDUFA, to carry the agency through Feb. 28. The agency confirmed these details, flagged by a blog run by law firm Hyman, Phelps and McNamara, to BioPharma Dive on Wednesday.
- More than 40 health groups, such as the American Society of Clinical Oncology and Patient for Affordable Drugs, signed onto a letter led by Friends of Cancer Research that pressures U.S. leaders to restore FDA funding.
As the partial government shutdown has continued, becoming the longest in U.S. history, pharma and biotech have begun to notice its effects on regulators like the FDA. All the while, the agency continues to devise plans to persist with limited resources.
The latest PDUFA timeline that Gottlieb gave to staff estimated the funding could stretch to Feb. 28, a longer timeframe than previously given.
Kurt Karst, a lawyer for Hyman, Phelps & McNamara, said in an interview Wednesday he was "a little surprised" that the agency thinks they can go that long into February. Earlier this month, Gottlieb ballparked PDUFA running out in early- to mid-February and has called it the agency's "most vulnerable program" on Twitter.
"That's good news," Karst said. "On the opposite side, that's not too far off."
Karst said it's unclear to him how the agency has decided to spend its limited resources, and if the shutdown will impact upcoming decision dates for drug candidates. Some drugmakers expecting regulatory decisions in the next few weeks include Novartis, Sanofi and Alkermes.
User fee programs for generic drugs and medical devices still have months of funding remaining, the FDA confirmed to BioPharma Dive.
And as the U.S. regulator hobbles forward amid the shutdown, dozens of research and patient organizations wrote Tuesday to President Donald Trump and congressional leadership from both parties to "raise alarm" on the risks the FDA's funding lapse poses to safety and science.
The groups argued the shutdown is forcing the agency to "make difficult choices" on deciding which essential functions receive the FDA's limited resources.
"These are decisions that never should have to be made — the health and safety of Americans today should never be weighed against the prospect of new life-saving therapies for patients," the letter stated. "Tragically, that is what is happening."
Despite meetings between the White House and Democrats over the past month, there have been few signs of a potential path forward to restoring funding and reopening the government.
An agreement between Senate Majority Leader Mitch McConnell, R-Ky., and Chuck Schumer, D-N.Y., could offer an opening, with competing votes set to be held Thursday on President Trump's proposal to spend $5.7 billion on a border wall and a continuing resolution to fund the government through Feb. 8. It's not clear if either measure has enough votes to advance.