HEALTH CARE BRIEFING: Impasse on Funding Imperils Reforms at FDA

As the Senate Appropriations Committee gathers today to hear from FDA Commissioner Robert Califf on his agency’s fiscal 2023 budget, former officials and policy watchers warn an impasse still remains among congressional leaders over industry fees that could force the agency to let go of thousands of employees and lose out on changes to its fast-track drug pathway.

Legislation reauthorizing the user fees that help fund the Food and Drug Administration came into question last week when Sen. Richard Burr (R-N.C.), the ranking Republican on the Senate health committee, seemingly walked away from months of negotiations. The deadline to reauthorize the fees is Sept. 30.

Burr introduced his own, stripped-down measure that omits several additions from the version (S. 4348) that the Health, Education, Labor, and Pensions Committee advanced last month, particularly a proposed overhaul to the accelerated approval pathway that gained renewed scrutiny after Biogen‘s Alzheimer’s drug approval.

House and Senate leaders previously said they wanted to have an agreement done by August, but Burr’s break from his fellow negotiators has made reaching that goal unlikely. But former senior agency officials, industry groups, and policy analysts say a compromise is still doable. Celine Castronuovo and Alex Ruoff have more.

Also on Lawmakers’ Radars

Democrats Move to Delay Obamacare Premium Rise, Create New Cliff: Democrats eyeing a permanent extension of the Obamacare subsidies to avoid creating another deadline now say they’re willing to take what they can get to avoid premium increases for 2023 and a rise in the uninsured rate. Senate Democrats are preparing a partisan bill to direct the federal government to demand lower prices for certain medicines and extend for at least two years expanded premium subsidies for people who get their insurance through the Affordable Care Act’s individual marketplace. Read more from Alex Ruoff and Tony Pugh.

Post-Roe Medical Care Delays Worry Democrats: Senate Democrats will try to get passage via unanimous consent Thursday on a measure to inject billions of dollars into federal family planning programs. The move is another effort by Democrats to pressure Republicans on pregnancy and abortion issues following the Supreme Court’s decision last month to overturn Roe v. Wade.

“If Republicans are serious about their promises to support women, protect their health, and invest in policies to lift families up, they will join us,” Patty Murray (D-Wash.), chairwoman of the Senate Health, Education, Labor and Pensions Committee, told reporters Tuesday, Alex Ruoff reports. Read text of the legislation here.

• The overturning of Roe v. Wade has fueled medical uncertainties for miscarriage care as well as procedures intended to treat chronic or life-threatening illness, Democratic lawmakers said Thursday. Patients are facing long delays in miscarriage health care, and medical professionals are deferring to hospital attorneys to make treatment calls, doctors told members of the House Energy and Commerce Committee’s oversight panel at a hearing Tuesday. Read more from Maia Spoto.
• Across the street from the Capitol, more than a dozen lawmakers—most from the Democratic Women’s Caucus—were arrested by US Capitol Police at an abortion-rights rally at the Supreme Court. Democratic Reps. Alexandria Ocasio-Cortez (N.Y.), Carolyn Maloney (N.Y.), and Nydia Velazquez (N.Y.) were among those detained and removed. Read more from Ella Ceron.
• Related: Legal Fight for Abortion in Mississippi Ends With Clinic’s Sale

Senate Eyes Research Tax Break in Chips Bill: The US Senate voted by a 64-34 margin to begin debate on legislation to provide more than $52 billion in grants and incentives for the American semiconductor industry, Daniel Flatley and Erik Wasson report. Meanwhile, a bipartisan Senate group is making a last-minute push to revive a tax break for corporate R&D in the bill. Sen. Todd Young (R-Ind.) said lawmakers are eyeing a one-year extension to a tax break for R&D costs that expired at the end of 2021, which would be a boon to drugmakers. Read more from Laura Davison and Erik Wasson.

DHS Revamps Health Office Amid Lawmaker Scrutiny: The Department of Homeland Security said it’s reorganizing part of its troubled Countering Weapons of Mass Destruction Office, but lawmakers are seeking further changes. DHS announced Tuesday that its chief medical officer will spin off from the division and lead a new Office of Health Security, a change lawmakers had long sought to address health threats to the US. Read more from Ellen M. Gilmer.

FDA Spending Amendments: The House plans a final vote on a 6-bill minibus spending package (H.R. 8294) today, which includes Agriculture-FDA legislation, Jack Fitzpatrick reports. Yesterday the chamber adopted an amendment by Rep. Cori Bush (D-Mo.) to add language to support a study on how low-level radiation affects human health and the environment. Read more about measures being debated in BGOV’s Closer Look.

Groups Call for $100 Million to Fight Monkeypox: Public health groups and LGBTQ advocates asked Congress for $100 million in the next Labor-Health and Human Services-Education appropriations bill to “ensure our country has sufficient resources to mount a robust response” to the Monkeypox outbreak. Read it here.

What Else to Know Today

FDA Begins Review of Food, Tobacco Divisions: The FDA is beginning an outside review of its offices that oversee safety and inspection activities for food and tobacco. Commissioner Califf has hired external experts to conduct a comprehensive review of the agency’s Human Foods Program, along with parts of the Office of Regulatory Affairs, and the Center for Tobacco Products, according to a statement. Read more from Fiona Rutherford.

Novavax Shot Gets CDC Sign-off: The 12-member panel of outside experts convened by the CDC voted unanimously to recommend Novavax’s Covid vaccine for adults. CDC Director Rochelle Walensky signed off on the advice from the Advisory Committee on Immunization Practices, which allows the shot to finally go into arms. Read more from Fiona Rutherford.

Black, Native Overdoses Surged in Pandemic: Overdose deaths among Black people and American Indians soared in the first year of the Covid pandemic, outpacing fatalities among Whites during the same time period, according to data released Tuesday by the CDC. Read more from Ian Lopez.

FDA Seeks Information on PFAS in Containers: Information on certain plastic food storage containers that may transfer PFAS onto food is being sought by the FDA through a request for information Tuesday. Read more from Nyah Phengsitthy.

More Headlines:

• US ‘Disrupted’ North Korean Hackers Who Breached Health Sector

With assistance from Jack Fitzpatrick

To contact the reporters on this story: Brandon Lee in Washington at blee@bgov.com; Alex Ruoff in Washington at aruoff@bgov.com

To contact the editors responsible for this story: Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com