DOCTORS ON OFFENSE — Members of Doctors for America’s FDA Task Force, a patient advocacy group, met Monday with the offices of Senate committee leaders about the impending confirmation hearings for HHS nominees, urging the panels to thoroughly vet them for conflicts of interest and their plans to fulfill their agencies’ missions. Dr. Reshma Ramachandran, a primary care physician and Yale Medicine professor, said the group especially wants senators to press Dr. Marty Makary, President-elect Donald Trump’s pick to lead the FDA, on where he stands concerning the agency’s mission of ensuring both the safety and effectiveness of drugs. Trump’s choice to be HHS’ No. 2, Jim O’Neill, argued a decade ago that the FDA should approve medicines once their safety is affirmed instead of requiring effectiveness data. Political independence: The group, which focused on the chairs and ranking members of the Senate Finance and Health committees, also wants the panels to press Makary on how he’ll insulate the FDA from political interference. Ramachandran noted that much of the federal statute vests authority in the HHS secretary and not the FDA commissioner specifically, a point some policy experts fear could be used by political appointees to upend longstanding public health initiatives like federal advisory committees. “It’s good to have a healthy skeptic in the role at FDA,” Ramachandran said of Makary, who’s long studied health outcomes at Johns Hopkins University. “My worry is he hasn’t had much experience running anything like the FDA.” TRUMP TIPS HIS PHARMA HAND — Trump repeated debunked theories about links between childhood vaccines and autism during an interview with NBC’s Kristen Welker that aired Sunday. But he also let slip some details about his recent confab with pharma execs and Robert F. Kennedy, his pick to lead the Department of Health and Human Services. “At Mar-a-Lago, I called the drug companies, the top drug companies, and I called RFK Jr., and Dr. [Mehmet] Oz, and some of his people, and I said, ‘Let’s all get together and let’s figure out where we’re going because we’re going to do a lot of things,’” Trump said. “Number one, we’re going to reduce prices because the middleman makes more money than the drug companies, in all fairness to the drug companies. There’s a middleman that nobody even knows who they are.” Trump said they also “talked about vaccines … in terms of what happens,” going on to question why autism diagnoses have grown in recent decades. Doctors say this is largely because of increased awareness of the condition’s presentations and broader diagnostic criteria. “I mean, something is going on. I don’t know if it’s vaccines. Maybe it’s chlorine in the water, right?” Trump said. Abortion pill cloud: Trump also said he probably won’t restrict the availability of abortion pills but cautioned that “things change.” Welker asked whether Trump would restrict abortion through executive action without Congress, including curbing availability of abortion pills, which Americans can get through the mail. “I’ll probably stay with exactly what I’ve been saying for the last two years. And the answer is no,” Trump said. But when pressed on whether he would commit to that, Trump demurred and pointed to President Joe Biden’s decision to pardon his son Hunter on federal gun and tax evasion charges after vowing not to consider it. VRBPAC ON DECK — The FDA’s vaccine advisory panel will meet Thursday to consider respiratory syncytial virus vaccine safety in children. While children aren’t currently eligible for RSV vaccination, pregnant people can be vaccinated between 32 and 36 weeks gestation. Babies may also receive a shot of RSV antibodies — a form of passive protection — when encountering their first respiratory virus seasons.
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