This bill ensures the FDA can continue reviewing human drug and device submissions during government shutdowns by allowing applicants to defer required fees until after the funding lapse ends.
Kevin Mullin
Representative
CA-15
The **Getting Innovations to Patients During Shutdowns Act** ensures that the FDA can continue processing critical human drug and medical device submissions during federal government shutdowns. By allowing applicants to defer required fees until after a funding lapse ends, the bill prevents administrative delays and ensures that life-saving medical innovations remain under review.
New FDA Rule Keeps Drug and Device Reviews Moving During Government Shutdowns: 7-Day Grace Period for Fees Established
When the federal government hits a funding stalemate and shuts down, the gears of bureaucracy usually grind to a halt. For the FDA, this often means hitting the pause button on reviewing the next life-saving drug or medical device because the paperwork fees—which fund the review process—can’t be processed. The 'Getting Innovations to Patients During Shutdowns Act' changes the rules of the game by allowing the FDA to keep the lights on for new applications even when the budget is in limbo. Under this bill, the Secretary can accept complete drug and device submissions without the immediate required fee during a lapse in appropriations. This ensures that a political standoff in D.C. doesn’t become a bottleneck for medical progress.
No Pay, No Problem (For Now)
In the real world, this works like a 'buy now, pay later' system for pharmaceutical companies and medical tech startups. Usually, if you don't send the check with the application, the FDA won't even look at it. Sections 736(e) and 738(f)(1) of the Federal Food, Drug, and Cosmetic Act are being tweaked so that during a shutdown, the FDA can start the clock on reviewing a new heart stent or a breakthrough cancer treatment immediately. For a biotech startup with limited runway, this prevents a three-week government shutdown from turning into a three-month delay in getting their product to market. The bill gives these companies a specific window: they must settle their tab within 7 days after the government officially reopens.
The Catch at the Finish Line
While the bill is designed to keep the assembly line moving, it includes a hard stop at the end of the process. Even if the FDA finishes its review while the government is still figuring out its budget, it cannot officially clear, authorize, or approve the product until that fee is paid in full. Think of it like a restaurant that lets you order and eat your meal while the credit card machine is down, but won't let you leave the building until you've settled the bill once the power comes back on. If a company misses that 7-day post-shutdown deadline, the FDA will treat the submission as incomplete and essentially act like it never happened. This ensures that while the review process is faster, the agency doesn't lose out on the critical funding it needs to operate in the long run.