What awaits Harris or Trump at the FDA

Nov 05, 2024

With Ben Leonard

Driving The Day

Dr. Robert Califf sitting at table during a congressional hearing

FDA Commissioner Robert Califf says that deciding the right amount of regulation for AI in medical devices will be a challenge. | Manuel Balce Ceneta/AP

THE FDA’S TO-DO LIST — The FDA faces policy challenges as technological advances roil health care and the agency fights for resources from Congress — no matter who wins the election.

Government funding expires on Dec. 20 — meaning Congress will be tasked with reaching a spending agreement before a new slate of lawmakers takes power next year.

“Regardless of who is elected, the FDA’s greatest challenges center around having the resources and support to maintain its global leadership position,” said Steve Grossman, executive director of the Alliance for a Stronger FDA.

Here are the three additional areas we’re monitoring:

Artificial intelligence: The FDA has been slowly expanding guidance around artificial intelligence in medical devices, decision support and, soon, its use in drug development.

“There’s a real challenge in figuring out how to avoid too much regulation in a field where a lot of creativity is occurring that can do a lot of human good but also figuring out where to use regulation to help the industry hopefully move in directions that actually improve the health of patients,” FDA Commissioner Robert Califf said at the HLTH conference last month.

So far, the FDA has authorized about 1,000 AI-enabled medical devices. But the technology presents unique issues for the agency. For example, AI can change over time, and while the FDA has instituted guidance around AI that requires updating, it’s limited in its ability to monitor postmarket technology. The agency told the GAO that to track whether algorithms are effective over time, it needs new authority from Congress to collect performance data.

Whether it gets that will depend on Congress. Alternatively, Califf has said the FDA is more of a referee than a sheriff, and mechanisms outside the government are needed to ensure AI is working.

“I love the term local, recurrent validation. What that means [is] if you want to know that your AI is doing what you thought it was doing, you actually need to validate in the situation in which it’s being used,” he said at HLTH. “I don’t know of a single health system in the U.S. which is capable of doing the validation. We need a major change.”

Drug shortages: Democrats and Republicans in the House and Senate want to pass legislation to cut down on shortages of critical drugs needed to treat cancer and other conditions, but a vehicle has remained elusive ahead of the election.

Califf has repeatedly quipped that he’s had to deal with shortages more than he ever anticipated when he returned to helm the agency in 2022. He’s called for greater authority to make manufacturers alert the FDA when demand spikes could lead to a supply crunch, and in the interim, he’s urged companies to volunteer more supply-chain data.

House Democrats have pushed for those sorts of power, while Republicans have favored exempting certain drugmakers from 340B and Medicaid inflation rebate programs.

Meanwhile, the Senate Finance Committee released a draft bill last spring incorporating portions of the Biden administration’s proposal to leverage the Medicare program to encourage purchasing and contracting decisions that promote supply-chain resiliency.

Staffing: The incoming administration must also choose who will lead the agency.

Califf served under two Democratic administrations and could remain in the top job for some time — but the cardiologist is in his seventh decade, and both Harris and Trump will likely want to put their stamp on the regulatory agency.

Top career staff have historically been among those asked to lead the FDA on an acting basis until the Senate confirms a new commissioner. One person to keep an eye on is Namandjé Bumpus, who rapidly ascended to become the FDA’s principal deputy commissioner after Dr. Janet Woodcock retired.

IT’S ELECTION DAY. WELCOME BACK TO PRESCRIPTION PULSE. We didn’t have Martin Shkreli sounding off on wanting to raise the price of mifepristone on our election-week bingo cards.

Send tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

Public Health

A doctor prepares syringes that contain the Pfizer/BioNTech vaccine.

Scientists want more funding to study vaccine safety to help restore public trust in immunizations. | Jens Schlueter/Getty Images

THE PUSH FOR VACCINE SAFETY DOLLARS — Amid the growing influence of vaccine skeptics within former President Donald Trump’s campaign, some academic scientists are calling for increased funding for vaccine safety research . Lauren takes a closer look at what the scientists are asking — and why.

To be clear, those experts don’t peddle vaccination conspiracy theories. Instead, they say studying rare adverse effects after shots — and their underlying causes — is key to restoring public trust in immunizations.

On top of existing safety studies, more research into safer childhood vaccines was supposed to happen under the 1986 law that created the Vaccine Injury Compensation Program, the no-fault alternative to the traditional legal system created after hundreds of personal injury lawsuits threatened national supply and uptake. But the excise tax imposed to fund the program was linked only to program payouts — not to subsidize that science.

Supporting that science, they say, would help counter claims like those made by Trump surrogates such as Robert F. Kennedy Jr. and, more recently, transition co-chair Howard Lutnick.

Where’s Congress? The scientists behind the proposal, which they say is budget-neutral because it would rely on surplus trust fund money, have yet to identify congressional supporters.

Separate legislative efforts to update the compensation program — which generally extends liability protections to the makers of routine childhood vaccines in exchange for funding it — have stalled in Congress amid cost questions and reluctance to wade into a live-wire topic.

Dan Salmon, director of Johns Hopkins’ Institute for Vaccine Safety, said advances in genomics and surveillance techniques since the law was passed create greater opportunities for scientists to study what adverse effects might occur after vaccination. That data could spur different recommendations for people based on underlying conditions and the development of new vaccine technologies.

“Preventing it is better than compensating for it,” Salmon said of an adverse vaccine reaction. “That’s what's needed scientifically, and that’s what the public wants.”

ELECTION 2024

BALLOT INITIATIVES — Voters will weigh in on several other health care-related measures nationwide, Ben reports.

We’re following some, including:

Medicaid: South Dakota voters will decide whether the state can impose work requirements in the safety-net program. Trump would likely need to win the White House for the rules to be implemented, though, because the federal government has to sign off on the changes.

Psychedelics: Massachusetts voters will determine whether to legalize the recreational use of some psychedelic substances for people 21 and older.

340B: California voters will choose whether the state should further scrutinize spending in the drug discount program. The program mandates drugmakers to sell outpatient drugs at discounts to hospitals, community health centers and many provider-based rural health clinics. Pharmaceutical companies have argued the program has deviated from its safety-net mission.

Marijuana: Florida, North Dakota and South Dakota citizens are voting on whether to legalize recreational marijuana for people 21 and older. DeSantis has fiercely opposed the initiative in his state.

Medically assisted suicide: A West Virginia ballot initiative would ban people from using medically assisted suicide in the state.

Pharma Moves

Emergent BioSolutions announced Dr. Simon Lowry will step in as chief medical officer and head of research and development on Nov. 18. He most recently was CEO of Mysthera Therapeutics.

Document Drawer

The White House Office of Information and Regulatory Affairs is reviewing FDA draft guidance on validating diagnostics for emerging pathogens during a public health emergency.

WHAT WE'RE READING

Science’s Kai Kupferschmidt explores why misinformation research is more complicated than people may realize.

The Biden administration urged a federal judge in Texas to dismiss an effort by three other states to restrict mifepristone access nationwide, arguing the venue is improper, Reuters’ Brendan Pierson writes.

More probable human avian influenza cases are being documented in Washington and California, CIDRAP's Lisa Schnirring reports.

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