The challenges ahead on drug policy

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Nov 08, 2024 View in browser   By Lauren Gardner With Sophie Gardner, Brittany Gibson and David Lim Driving the day Now President-elect Donald Trump holds a rally in Glendale, Arizona. | Rebecca Noble/Getty Images TRUMP TRIPWIRES — President-elect Donald Trump’s decisive victory means he’ll reenter the White House with a mandate to upend the Biden administration’s policy achievements. But just how much will he be able to shake up the FDA and Medicare? While Trump has surrounded himself with iconoclasts like Robert F. Kennedy Jr. who want to overhaul the federal public health apparatus, its sprawl and deeply rooted infrastructure could make a significant shakeup difficult. Still, Trump is likely to find ways to leave his mark. Lauren and David took a look at three: Drug pricing: This is a big one for Trump, who on the campaign trail called for lowering prescription drug costs without offering substantive proposals to do so. While Trump backed efforts to ensure Medicare didn’t pay more for drugs than other high-income countries, President Joe Biden rescinded his predecessor’s executive order and pushed through Congress a long sought-after negotiation program. It’s unclear whether there’s enough interest and support among GOP lawmakers to repeal the program, which they oppose, since it’s popular with older Americans. That could give HHS under Trump an opening to find ways to tweak the program within the statutory lines. It also raises the question: Would a Trump DOJ continue defending the law in court against drug companies? If government lawyers backed down, blue states and supportive groups could take up the legal mantle. Lab-developed tests: Republicans in Congress want to see the FDA’s final rule subjecting those devices to stricter regulation scrapped, and the next administration could grant their wish. Yanking the rule would put the ball back in Congress’ court — where it has languished for years. Staffing: We have more on transition chatter below, but even the specter of Kennedy has some in the FDA spooked, according to former officials granted anonymity to discuss morale. "They're worried — they've been through transitions before so they clearly understand how to do that, but they read the news, the same as you and me," said one former official. "I think it's a lot of RFK-driven stuff." IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. What a year this week has been. Are you trying to get a job in the next administration? Let us know — we can keep you anonymous. Send tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).   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.     2024 ELECTION PERSONNEL IS POLICY — Kennedy attended a day of meetings Wednesday at Trump’s Mar-A-Lago resort with Elon Musk, Amaryllis Fox Kennedy, donor Tom Barrack, Calley Means, Tucker Carlson and Donald Trump Jr. to talk about the transition of power and potential candidates for health positions in the next administration. Two people familiar with the discussions say four names are being floated by Kennedy's camp: — Dr. Jay Bhattacharya, director of Stanford’s Center on the Demography and Economics of Health and Aging; — Dr. Joseph Ladapo, Florida’s surgeon general; — Dr. Marty Makary, Johns Hopkins public policy researcher and surgeon; and — Dr. Casey Means, a chronic disease entrepreneur linked to the “Make America Healthy Again” movement. “He wants gold-star scientists and a reform mindset, an independent-thinking mindset,” one person familiar with the talks said. A second person said others are trying to offer additional candidates for Trump to consider for the FDA and related agencies. The coming vetting: Most of those choices are likely to draw pushback from public health experts and Democrats. Ladapo personally edited a state-driven study about Covid-19 vaccines to suggest the risks of cardiac death were more severe than had been established by the broader medical community, according to a document released under a public records request . Bhattacharya and Makary advocated against lockdowns and mask mandates for children, respectively, during the Covid pandemic. Taking a beat: What’s unclear for now is exactly how much influence Kennedy will have on personnel decisions — as well as how far his acolytes can make it into the administration. FDA commissioner is a Senate-confirmable position, and while Republicans have a comfortable majority, the remaining moderates could find a few colleagues to help stymie the most controversial nominees. Former Sen. Richard Burr, previously the top Republican on the chamber’s health committee, told POLITICO he didn’t think the Kennedy-associated names were “serious.” “This has been a very controlled process” compared to the last transition, he said. “Either for their own interest or they’re working on behalf of somebody inserting names into consideration, I don’t think you can take that as consideration by the transition team.” Call and response: Florida Gov. Ron DeSantis is promoting Ladapo for a Trump administration gig. “Retweet if you’d like to see this man — Dr. Joseph Ladapo — serve as the Secretary of HHS in the new Trump administration,” he posted on X Wednesday. One person familiar with the transition suggested Ladapo would be more likely to be named surgeon general or assistant secretary of health. Makary and Means didn’t respond to requests for comment. “I have not heard that I am being considered for the FDA job,” Bhattacharya said in an email. BIRD FLU BIRD FLU UNDERCOUNT? — The CDC expanded its testing guidance Thursday after new data suggested a significant number of bird flu cases are going unreported, POLITICO’s Marcia Brown reports. The details: CDC data show that 7 percent of farmworkers, or 8 out of 115, exposed to H5N1 on dairy farms in Michigan and Colorado showed evidence of a recent H5N1 infection — indicating the true number of human cases could be higher than reported. The infections found by the serology tests — blood tests that determine evidence of a prior infection — will not be counted as part of the national case count. As of Thursday, 46 people had confirmed avian influenza infections. The CDC still classifies the risk to the general population as low. New recommendations: The CDC now recommends testing for workers who were exposed but did not show signs of an infection, especially when workers did not wear the recommended protective equipment, such as goggles or masks. Officials also recommend Tamiflu for workers with known exposure and who did not wear protective equipment, even if they do not show signs of an H5N1 infection. The CDC is urging workers to wear personal protective equipment during what the agency views as high-risk activities, such as culling infected poultry flocks or caring for sick cows. What’s next: The CDC is conducting another serology study in Ohio with 150 bovine practitioners who have worked closely with cattle in the last three months. Eye on the FDA FDA PROPOSES COLD MED OVERHAUL — The FDA on Thursday proposed pulling the leading ingredient in common cold medications from the market, arguing it’s not effective at relieving congestion. If finalized, the move could reshape the market for over-the-counter cold medicines. A more effective ingredient exists, but those products are kept behind pharmacy counters due to Drug Enforcement Administration regulations to prevent them being used to make illicit drugs. The FDA will accept public comments on the proposal for six months, meaning any change is likely a few cold seasons away. what we're reading Members of an EU alliance want the European Commission to invest in drug production in low- and middle-income countries to help tackle drug shortages, POLITICO’s Rory O’Neill reports. POLITICO’s Robert King describes what could change at the Centers for Medicare and Medicaid under Trump.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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