HEALTH CARE BRIEFING: House Vote Set on FDA User Fees Revamp

The House plans to consider sweeping bipartisan legislation that would reauthorize the drug and medical device industry user fees that will help fund the Food and Drug Administration from fiscal years 2023 through 2027.

User fees make up nearly half of the agency’s total budget, and are considered must-pass legislation. The package (H.R. 7667) includes proposals to improve the FDA’s medical product review process. It would also revamp the accelerated approval pathway, including by giving the agency the authority to remove from the market any drugs that obtained fast-track approval if they fail to show a clinical benefit.

The package would also allow the FDA to require drug and device companies to submit diversity action plans for their clinical trials and includes provisions to speed up the approval of generic drugs.

House leaders plan to hold a vote under an accelerated suspension of the rules, which requires a two-thirds majority.

The Senate Health, Education, Labor and Pensions Committee is scheduled to mark up its own version of the user fee package Wednesday. The proposal from Sens. Patty Murray (D-Wash.) and Richard Burr (R-N.C.) doesn’t include provisions on clinical trial diversity and a House amendment that would help boost pediatric cancer research.

For more, see the BGOV Bill Summary by Christina Banoub.

Happening on the Hill

Doctors, Nurses Plead for ATF Chief Bottled Up by GOP Objections: A coalition of doctors, hospitals and nurses called on the Senate to confirm Biden’s nominee to lead the Bureau of Alcohol, Tobacco, Firearms and Explosives, with some arguing the agency is an urgent priority following a string of horrific mass shootings.

Eight medical organizations issued endorsements for the nominee, Steve Dettelbach, on Monday in letters obtained by Bloomberg News. But the ATF has long gone without a Senate-confirmed leader because of political disputes over guns between Republicans and Democrats. Josh Wingrove has more.

Covid Talks Stall: Covid funding aid talks have stalled, Sen. Richard Burr (R-N.C.) said in a hallway interview yesterday, Jack Fitzpatrick reports. The Biden administration hasn’t followed up with any further information, and there haven’t been conversations about how to offset the cost of the spending bill.

Senators previously agreed to a $10 billion bill to provide domestic Covid resources, including rescissions of previously appropriated stimulus funds to offset the bill’s cost. But after progress stalled, some of the money marked as offsets was spent. Lawmakers would have to renegotiate the bill in order to pass a Covid funding measure. Read more.

The Coronavirus Pandemic

Health Worker Vaccine Rule Case Poised to Go Back to Lower Court: The Fifth Circuit signaled it will vacate and send back a lower court decision to block the Biden administration’s health worker vaccine mandate across the country after the US Supreme Court allowed the rule to take effect.

“We’re going to remand, no question about that. On a preliminary injunction, you gotta send it back,” Judge Catharina Haynes said Monday during arguments in a case that tests the Medicare agency’s power to mandate health and safety conditions for health-care workers. Read more from Allie Reed.

More Headlines:

• Moderna Shield Argument on Vaccine Royalties Rejected by Rivals

What Else to Know

US Nursing Homes Face Closure Risks From Staffing Shortages: Almost three quarters of nursing homes say they’re at risk of closing due to staff shortages, with more than half operating at a loss, according to a survey. If things don’t improve, most fear that resources won’t be enough to keep them in business for more than a year.

Expenses are 41% higher than a year ago, and more than half of those polled said finding workers is even more difficult this year, according to a study from the American Health Care Association released Monday. The staff shortfalls are forcing homes to turn away potential residents at a time when occupancy rates are already far lower than before the pandemic. Lauren Coleman-Lochner has more.

More Headlines:

• USDA Offers Nationwide Waiver for Infant Formula
• Bristol-Myers Gets First Nod for $11 Million HIV Drug Settlement
• Connecticut Law Requires Medical Device Makers to Report to FDA

To contact the reporters on this story: Giuseppe Macri in Washington at gmacri@bgov.com; Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editor responsible for this story: Andrew Small at asmall@bgov.com