Last-minute regulations? Don’t hold your breath.

Nov 12, 2024

Presented by 340B Health

Driving the Day

Menthol cigarettes and other tobacco products are displayed at a store in San Francisco.

Some FDA rules, like a menthol ban, face an uncertain fate in the final days of the Biden administration. | Jeff Chiu/AP

WAITING IN THE WINGS — A slew of rules is sitting at the White House awaiting the Biden administration’s sign-off before the FDA can issue them. How many — if any — are pushed out the door before President-elect Donald Trump is inaugurated in January remains to be seen.

The threat of a Congressional Review Act effort looms over every final rule released until then, and proposals published in that period could languish under the incoming Trump administration. Still, FDA lobbyists point to a few candidates for advancement because they’re either statutorily mandated, not overtly political or both.

Tobacco regulation: The Biden White House is sitting on two final rules that would restrict the sale of menthol cigarettes and flavored cigars, but the threat of congressional review could keep them on ice.

A former FDA staffer granted anonymity to discuss what regulations Biden could push out before he leaves office noted the uncertainty surrounding what the CRA’s restriction on reintroducing regulations in substantially similar form means.

“There is significant downside potentially to putting out a rule banning menthol, having that go through the CRA process, where then the agency would not be able to reintroduce a rule substantially similar to that,” the former FDA staffer said. “So it may decide not to move forward with it at all rather than face that possibility.”

Talc in cosmetics: This proposed rule, which would set standardized testing methods for detecting asbestos in cosmetics containing talc, was mandated by the 2022 law overhauling the FDA’s authority over that product class.

By law, the agency was supposed to issue the proposal at the end of 2023, but the FDA didn’t send it to the Office of Management and Budget until Jan. 2, where it’s remained ever since.

“FDA’s failure to do something as basic as protecting us from asbestos in an everyday product is one of many reasons people have lost faith in the FDA,” said Scott Faber, senior vice president for government affairs at the Environmental Working Group.

The law directs the FDA to finalize the rule six months after the proposal’s public comment period closes, though agencies often blow such deadlines.

Rx-to-OTC drugs: This proposal is a nonpartisan issue but has floundered at the agency in different iterations for years.

The current version — known as “additional conditions for nonprescription use,” or ACNU — would set requirements for over-the-counter drugs that call for more consumer education than a label can provide to ensure users can safely take the medication without provider supervision.

An example would be a questionnaire a consumer completes through an app to demonstrate they understand the directions before purchasing the product.

When proposing the rule in 2022, the FDA said it would help expand OTC options for consumers and thus help public health. But some in industry and Congress have opposed a portion of the rule that would allow prescription and nonprescription versions of the same drug to be marketed simultaneously, arguing that would illegally undermine the existing regulatory pathway for prescription-to-OTC switches.

IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. How are the vibes in White Oak?

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

A message from 340B Health:

Pharma’s rebate schemes dodge their obligation to provide 340B hospitals with upfront discounts. By delaying rebates, drug companies would force 340B hospitals to purchase 340B drugs at full price and wait for drugmakers to decide when — and whether — to rebate the difference. Lawmakers must protect 340B by blocking this harmful tactic. Let’s hold drug companies accountable and ensure 340B hospitals can continue serving our most vulnerable populations without financial strain. Learn more.

ELECTION 2024

Robert F. Kennedy Jr. exits the Nassau County Supreme Court.

While names in Robert F. Kennedy's circle have been floated as contenders to become the next FDA commissioner, veterans of the health care establishment could come into play. | Stefan Jeremiah/AP

NON-RFK WORLD COMMISSIONERS? During Trump’s first term, he leaned on traditional mainstream Republicans with health care backgrounds to lead his FDA. While unconventional options are circulating — including names tied to Robert F. Kennedy Jr. — Republicans who closely watch the agency caution that serious contenders outside that sphere could be flying under the radar.

One takeaway from Biden’s eventual decision to nominate a former FDA leader — Dr. Robert Califf — is that potential candidates might be reluctant to lead the agency in the years following the height of the Covid-19 pandemic. The Trump White House famously clashed with his second FDA chief — Dr. Stephen Hahn — during the pandemic over emergency use authorization of unproven Covid treatments such as hydroxychloroquine.

Former agency officials from Trump’s first term could reemerge, such as Dr. Anand Shah, who worked as FDA deputy commissioner for medical and scientific affairs. Former FDA Commissioner Scott Gottlieb was well received by both Republicans and Democrats on Capitol Hill during his tenure, but his support for tobacco restrictions and decision to join the boards of several companies, including Pfizer, after leaving the agency could pose roadblocks.

Potential nominees could also be scouted from the various GOP lawmakers with medical backgrounds on Capitol Hill.

REGISTER NOW: What the 2024 Election Means for FDA. The 2024 elections will significantly impact the FDA’s policy agenda and regulatory approach. Join AgencyIQ by POLITICO post-election for an expert discussion on how these changes will affect the FDA's regulation of pharmaceutical and life sciences companies. Register here.

Industry Intel

NOVAVAX CLINICAL TRIAL HOLD LIFTED — Novavax will begin enrolling for its Phase III clinical trial of its flu and Covid-flu combination vaccines after the FDA ended its hold on the program, the company said Monday.

The hold announced last month came after a serious adverse event was reported in a participant who received the combination vaccine in an earlier trial. Additional information showed the participant had amyotrophic lateral sclerosis, or ALS, which Novavax said “is not known to be immune-mediated or associated with vaccination” and was determined to be unrelated to the shot.

CIGNA THROWS COLD WATER ON HUMANA MERGER — Cigna, one of the largest insurers in the U.S., said Monday it is not merging with rival Humana, POLITICO’s Kelly Hooper reports.

“The Cigna Group remains committed to its established M&A criteria and would only consider acquisitions that are strategically aligned, financially attractive, and have a high probability to close,” said a company press release.

A message from 340B Health:

Document Drawer

The House Oversight Committee will hold a hearing Thursday at 11:30 a.m. ET on how the U.S. should prepare for the next pandemic — which could be an early signal of potential actions a Republican Congress and White House might take if the GOP controls both branches of government next year.

WHAT WE'RE READING

POLITICO’s Ben Leonard chats with Rep. Bob Latta , chair of the House Energy and Commerce Communications and Technology Subcommittee, who is running to be chair of the full committee next Congress.

The New York Times sat down with Dr. Richard Pazdur, the FDA’s chief cancer drug regulator, to discuss advances in oncology drug development since he began practicing medicine decades ago.

A message from 340B Health:

Pharma’s rebate schemes are a deliberate dodge, sidestepping their obligations to provide upfront discounts that 340B safety-net hospitals rely on. By replacing immediate discounts with delayed rebates, drug companies force disproportionate share (DSH) hospitals to pay full price for medications and endure months-long waits for refunds. This dodge tactic drains hospital resources and disrupts access to critical care for low-income, rural, and underserved communities. When 340B hospitals are forced to operate under these rebate schemes, the victims are the patients and communities they serve.

340B hospitals provide 77% of Medicaid hospital care and 67% of uncompensated care in the U.S. Without vital 340B savings, many hospitals will be forced to scale back or eliminate programs, leaving patients and communities without access to affordable care. Lawmakers must act now to end this rebate dodge and hold drug companies accountable to the program’s original intent. Learn more.