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| By Lauren Gardner and David Lim | With Kelly Hooper
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 Dr. Robert Califf, who will be leaving his post as FDA commissioner, says he's leaving the agency in good shape. | Pablo Martinez Monsivais/AP |
CALIFF HEADS FOR THE EXIT — FDA Commissioner Robert Califf is closing the book on his second stint leading the agency that regulates products accounting for about 20 cents of every dollar that Americans spend. The cardiologist spoke with reporters Thursday during what he called his “last few hours” at its White Oak headquarters before he planned to drive home to North Carolina. During the hourlong virtual roundtable, Califf touted his efforts to reorganize the FDA’s vast inspector workforce and its beleaguered food division, as well as to work through the backlog of millions of tobacco-product marketing applications.
“I feel good about the shape that we’re leaving the agency in,” he said. Outside criticism: Still, several public health experts and lawmakers told Prescription Pulse the low-key leader didn’t do enough to effect change in key areas like public trust in the agency, tobacco addiction and Americans’ unhealthy behaviors — the last of which is the chief focus of President-elect Donald Trump’s slate of health care nominees. “He’s a Looney Tune, but he is tapping into a real sense among Americans” of wanting to know what goes into their bodies, one House Democrat who’s critical of Califf’s tenure said of Robert F. Kennedy Jr., Trump’s choice to be HHS secretary.
MAHA dodgeball: Califf resisted opining on the positions of Kennedy and others who might succeed him in government, but he did nod to the nominee’s famous X post calling on FDA officials to “preserve your records, and … pack your bags.” “Well, I’m packing my bags — which was going to happen anyway — but I would say ‘preserve your records’ because I think the documentation of vaccine benefits and vaccine risks is extremely well done,” he said. “I don't think people are going to find any surprises,” Califf added. “I think it’s all out there.”
IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. We couldn’t help but notice that the FDA this week updated its webpage on thimerosal in vaccines to reflect that more than 20 years of research shows the preservative isn’t linked to autism. Send your tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
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 Zyn nicotine pouches won FDA authorization on Thursday. | Bebeto Matthews/AP |
REG DUMP — The FDA had a prolific week, ushering several high-profile regulations and marketing decisions out the door ahead of Inauguration Day. The agency green-lit the sale Thursday of 20 varieties of Zyn nicotine pouches in a win for the tobacco industry and for lawmakers who have urged regulators to authorize more alternatives to combustible cigarettes. At least one House Energy and Commerce Committee member, North Carolina Republican Richard Hudson, noted his excitement on X about the decision, which is the first time the FDA has authorized such pouches that users place between their gum and lip. That decision came a day after the FDA proposed the first limit on the amount of nicotine in traditional cigarettes, which would cut the amount of the chemical added to the products by 96 percent. While antismoking groups cheered the nicotine proposal, some criticized the agency for endorsing products they say plainly appeal to children. Most of the products the FDA authorized are flavored — including citrus, coffee and mint varieties — though the decision didn’t include other fruity options Zyn makes. Food side: The FDA also issued two major food regulatory rules, banning the addition of Red Dye No. 3 to food products Wednesday and proposing front-of-package labeling Tuesday that would require prominent display of saturated fat, sodium and added sugar quantities. The moves have been in the works for at least a decade, but they take on renewed significance as the so-called Make America Health Again movement gains a foothold in the next Trump administration. Califf’s lament: “It’s fascinating to me that Red Dye No. 3 has gotten so much more press than this massive tobacco proposed rule — a trillion dollars a year in savings for 40 years, millions of lives saved — and it's gotten so little press compared to Red Dye No. 3, which, as best I know, there’s no definitive evidence that it causes cancer in people,” Califf said during the reporter roundtable.
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NEXT DRUGS FOR NEGOTIATIONS COMING — The next slate of drugs selected for Medicare negotiations is expected to be announced today. Two people familiar with planning granted anonymity to discuss the rollout said the Biden administration had committed to announcing the next round before Jan. 20. The list of 15 Part D drugs, whose negotiated prices won’t take effect until 2027, is expected to include GLP-1 weight-loss drug Ozempic. Other possible product candidates include asthma inhalers and cancer drugs.
Merith Basey, executive director of advocacy group Patients For Affordable Drugs, noted that President-elect Donald Trump has signaled interest in lowering drug prices but said trying to predict how his administration will approach the price talks is “kind of a fool’s errand.”
“Given the platform that Donald Trump and the new administration have run on in terms of lowering costs and saving taxpayer money, we know that obviously preserving this law is a fiscally responsible choice and is in line with those promises they’ve made to consumers,” Basey said. Another lawsuit: Teva Pharmaceuticals, a major generic drugmaker that also manufactures branded products, sued HHS on Tuesday over the negotiation program, signaling the company expects its drug for movement disorders, Austedo, to be included in the next round.
| | OPTUMRx UPDATES REBATE POLICY — UnitedHealth Group’s pharmacy benefit manager, OptumRx, will now pass on 100 percent of discounts it receives on prescription drugs to its clients — which include employers, unions and health plans, Kelly reports. The current policy has OptumRx — which works on behalf of health plans to negotiate rebates and discounts on drugs — pass through more than 98 percent of rebates to clients. The move to pass on all rebates is intended “to remove any lingering doubt about our financial incentives,” OptumRx CEO Patrick Conway said in an interview with POLITICO.
The policy update comes as the country’s three largest PBMs — OptumRx, CVS Caremark and Cigna’s Express Scripts — have come under bipartisan scrutiny in Congress over their role in rising prescription drug costs. OptumRx will be the first of the big three PBMs to pass through all discounts to clients. “This makes it clear that we will always focus on the most affordable, lowest cost drugs and that we want pharma manufacturers who set the high prices of list drugs to lower the prices,” said Conway.
Key context: The change comes days after a Federal Trade Commission report found that the three largest PBMs significantly marked up generic drugs for serious illnesses, including cancer, heart disease and HIV. The report followed another FTC study released in July that found PBMs’ market consolidation is hiking drug costs and squeezing independent pharmacies. PBMs have countered the claims, maintaining that they play a critical role in lowering drug prices. “This announcement has nothing to do with the FTC report,” Conway said. “It is simply because we thought it was the right time to step out and be a leader in the industry about the importance of passing on 100 percent of these rebates to our customers.” What’s next: OptumRx will transition all clients to 100 percent pass-through plans by 2028 because clients often renew contracts in three-year cycles, Conway said.
| | FORMER TRUMP HEALTH OFFICIAL DIES — A key senior health official who played a central role in Operation Warp Speed during President-elect Donald Trump’s first term has died, POLITICO’s Lauren Gardner and Adam Cancryn report. Paul Mango’s death was confirmed by four people with knowledge of his passing, who were granted anonymity because of the sensitivity of the matter. A longtime health care consultant, Mango spent three years in the Trump administration, including as deputy chief of staff at HHS and was central in the creation of Operation Warp Speed, the federal initiative designed to accelerate the development of a Covid-19 vaccine. Mango was tapped to help with transition plans for the federal health department after Trump won reelection in November. He most recently was an adviser at Paragon Health Institute, a conservative think tank.
| | The FDA will hold a workshop on March 27 and 28 on improving the design of pregnancy registries to inform the safety of medical products during pregnancy.
| | Sen. Jim Risch (R-Idaho), chair of the Senate Foreign Relations Committee, said Thursday the global AIDS-fighting program started by President George W. Bush “is certainly in jeopardy” because the Biden administration allowed some of its funding to be spent on abortions, POLITICO’s Carmen Paun reports Pfizer CEO Albert Bourla said the “extreme left” had influence in the Biden administration and “not only hate business, they particularly hate us,” STAT News’ Matthew Herper reports. | | | |
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