FDA buffeted by uncertainty amid rolling CRs

The latest stopgap spending bill may have kept the Food and Drug Administration funded through mid-January but did nothing to settle the bitter policy fights hanging over the agency's operations.

Why it matters: Continuous funding cliffs weigh heaviest on FDA functions that aren't supported by industry user fees and would have to rely on carryover funds or other contingencies if there's a shutdown.

• The longer the uncertainty, the harder it is to plan non-essential activities.

The laddered CR that Congress cleared last week will keep funding for FDA in place only through Jan. 19. Its FY2024 budget would still be subject to the whims of a volatile appropriations process.

• The House's Agriculture-FDA spending bill has been one of the most problematic and was pulled from consideration once in July before being voted down on the floor in September.
• The Senate passed a bipartisan bill covering FDA earlier this month that's free of contentious riders.
• Most of the focus has been on a provision in the bill that would overturn current FDA policy that allows for the abortion pill mifepristone to be distributed by mail and at retail pharmacies.
• It's certain to not fly in the Democrat-controlled Senate or with the White House, which has threatened to veto the House bill.
• There are also concerns about deep spending cuts to farm programs and the WIC program, which provides nutrition assistance to low-income families.

The House bill originally kept the FDA funded roughly at the agency's FY2023 level of $6.56 billion.

• But Agriculture-FDA Appropriations subcommittee Chair Andy Harris later added a manager's amendment that would make another 14% cut across the board, except to WIC funding.

What they're saying: "In a sense, the Ag-FDA bill is a microcosm of disagreements within the Republican caucus," Steven Grossman, executive director of the advocacy group Alliance for a Stronger FDA, wrote in a recent analysis.

• "There are neither 217 Republican votes if the [abortion pill] provision stays in the Ag/FDA funding bill nor 217 Republican votes if the provision is dropped," he continued. The GOP "caucus is divided over spending levels, cuts to specific programs and policy riders."
• "Unless something changes, Speaker Johnson will have the exact same problem on January 19 as he did on November 17," Grossman added. "The agency's budget is very much at risk."

Threat level: The FDA thrives when it is predictable and when its decisions are reproducible, Peter Pitts, a former FDA associate commissioner in the George W. Bush administration, told Axios.

• "When funding is conditionally available, it's certainly better than having it not be available at all. But it also leaves room for reasonable doubt as to whether or not the agency is going to be able to hit its targets," he said.
• What that means is drug and device makers, as well as manufacturers of diagnostics and biologics, will ask, "How do we know for sure that the FDA is going to stick to its promised calendar, because we're not exactly sure whether or not the money is going to be there?" Pitts said.
• A PhRMA spokesperson said that while the drug industry can count on user fees to fund product evaluations for several weeks, there is concern that a prolonged shutdown could erode regulatory predictability.

• "Any time Congress doesn't pass appropriations bills for a full year, it causes us to be slightly concerned," said Scott Whitaker, CEO of AdvaMed. "The preference is always for predictability in the system."

Of note: The FDA didn't respond to questions about budget uncertainties but appears resigned to living with flat funding in the near term.

• "We're not wrapped up in the political fights, we live day to day, and we have to live with the consequences of what Congress does," commissioner Robert Califf said in an interview with the National Association of Hispanic Journalists last week.
• "Realistically at best, we're gonna have a flat budget, that would be at best, until after this upcoming election," he noted. "So we have to be realistic about that ... and carefully watch our utilization of people to make sure they're working on the things that are most important."

What we're watching: Both chambers of Congress recessed last week without a plan for coming to a resolution with the Agriculture-FDA bill or the other spending measures.

• Speaker Mike Johnson has acknowledged the hurdles ahead and while running for speaker pledged to create a new working group to address concerns with the FDA bill.

Our thought bubble: Finessing abortion politics will be difficult and could antagonize conservatives in the House GOP caucus. It could also drag out what's so far been a losing issue for Republicans at the polls.