BECERRA COMMENTS RILE CONSERVATIVES — The Biden administration has entered a delicate phase in its fight against the coronavirus pandemic, as it intensifies efforts to reach the unvaccinated. One example: the fallout from HHS Secretary Xavier Becerra's insistence Thursday that "it is absolutely the government's business" to push for coronavirus vaccination. “It is taxpayers’ business, if we have to continue to spend money to try to keep people from contracting Covid and helping reopen the economy," he said on CNN, touching off a new firestorm over a door-to-door outreach campaign that conservatives have sought to portray as government overreach. Becerra clarified his stance within hours, saying his comments were “taken wildly out of context” and that officials are simply encouraging people to get vaccinated. “To be clear: government has no database tracking who is vaccinated,” he tweeted. White House Covid-19 response coordinator Jeff Zients also offered a rebuke, accusing critics of fueling misinformation and "doing a disservice to the country." FDA NARROWS USE OF NEW ALZHEIMER’s DRUG — The agency’s additional guidance for Biogen’s Aduhelm, initially approved for all Alzheimer’s patients, now recommends the treatment only be used for those with mild cognitive impairment or mild dementia, POLITICO’s Katherine Ellen Foley reports. The FDA has faced heavy backlash for approving Aduhelm at all, as there is thin evidence that the drug actually works. But Biogen itself submitted the revised language for the drug’s new label, saying in a statement that it wanted to “further clarify the patient population” that was studied in Aduhelm’s clinical trials. In its own statement, the FDA also alluded to worries about Aduhelm being prescribed to such a large population — which, STAT reported, included even some top officials at the agency. The Alzheimer’s Association was one of the groups to raise the labeling issue during a public meeting it hosted and that federal health officials had registered to attend. The focus will soon shift to another dilemma: who should pay for this expensive new drug. The insurer lobby America's Health Insurance Plans has asked CMS to create a national standard for how Aduhelm (and its $56,000 annual price tag) is covered, citing its “extraordinary clinical uncertainties.” AHIP is also asking for clarification on whether CMS will have the Medicare program cover the pricey medical imaging used to detect Alzheimer’s disease, POLITICO’s Rachel Roubein writes. The FDA hasn’t yet indicated how it plans to handle the decision, but it’s a call that will have huge repercussions for a Medicare program that covers tens of millions of older Americans — many of whom may someday qualify for Aduhelm treatment. CALLS MOUNT FOR FDA TO FULLY APPROVE COVID VACCINES — The agency is under increasing pressure to say when it plans to grant the three approved Covid-19 vaccines full licensure, as public health experts argue the agency is moving too slowly. Both Pfizer and Moderna submitted their applications on a rolling basis, though Pfizer told POLITICO’s Lauren Gardner that it’s already handed in its final documentation. The vaccines’ real-world results, though, should offer enough data on their own for regulators to endorse the shots, some prominent health experts contend. More than 183 million Pfizer doses and 135 million Moderna doses have been administered in the U.S., with overwhelmingly positive results. And as vaccinations in the U.S. slow, supporters of full approval say that could convince some of the remaining unvaccinated population to get their shots. “I don't think there’s anything that can move the needle more in the U.S.,” said Eric Topol, director of the Scripps Research Translational Institute. But the FDA is so far refusing to budge, saying only that it’s “working as quickly as possible.” It’s also unclear how much the full seal of approval would ultimately spur vaccinations; in recent Kaiser Family Foundation polling, only about a third of unvaccinated adults said they’d be more likely to get a shot if it were fully licensed.
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