CALIFF HOLDS COURT — FDA Commissioner Robert Califf fielded questions for more than four hours in Congress on Thursday, vacillating between testy exchanges on Covid-19 misinformation and displays of Southern charm (he’s from South Carolina, he reminded members). Here are the biggest takeaways from his testimony before the House Oversight Committee: Covid misinformation: Some Republican members blasted the FDA’s pandemic-era messaging on ivermectin, an antiparasitic drug that some doctors and conservatives touted as a Covid treatment, as overstepping into the state-regulated practice of medicine. The agency recently settled a lawsuit over its public statements advising against ivermectin use to treat the disease. But Califf held firm that ivermectin — while effective as a deworming treatment in humans — has no efficacy against Covid. “We didn’t retract everything we had to say about ivermectin,” he said, later adding: “There’s just no benefit” against Covid. Illegal vapes: Democrats and Republicans pressed Califf on the FDA’s slow pace when evaluating new tobacco product applications, of which more than two dozen have been approved. The agency has denied millions of other e-cigarette products. Califf insisted the FDA is making progress, having processed 99 percent of the applications. But members said the agency has ignored “serious” marketing proposals that could meet FDA standards. Lawmakers in both parties also took Califf to task over the proliferation of flavored vape products imported from China, which they say appeal to children. Rep. Raja Krishnamoorthi (D-Ill.) suggested the agency didn’t respond to a congressional letter asking questions about its approach to managing the issue “perhaps because you don’t have an answer — it’s because you don’t have an approach.” Avian flu: Califf expressed confidence that antiviral medicines in the national stockpile would work against the circulating strain of avian flu. “There’s nothing in it that should confer resistance to the current antivirals that we have stockpiled,” he said of the viral structure. Government agencies are holding “Zoom congresses” multiple times a day as they monitor the spread of avian flu among cattle, Califf said. One farmworker has been identified as having contracted the virus. Patents: Califf was asked about drug prices, shortages and availability that he said fall outside the agency’s authority. But questioning by Rep. Ro Khanna (D-Calif.) on patent listings yielded an interesting exchange. Khanna pressed Califf on how drug manufacturers use the Orange Book, the FDA’s patent registry for approved drugs, to list patents to shield themselves from competition for some years. Califf said the agency has “not much discretion” on what patents get added to the list and if it declined to include any, “We’d get sued.” Liberal lawmakers have urged the FDA to update guidance for drugmakers listing patents in the Orange Book; the agency has indicated it will later this year. Mifepristone: Califf declined to answer some questions about the FDA’s regulation of the abortion drug mifepristone, noting the pending Supreme Court decision regarding agency actions that expanded access to the pills. But he said that overturning the FDA’s policies would set a troubling precedent for drug development. Ethics: Khanna asked Califf to commit to not taking any consulting fees from pharma companies after he leaves government. The commissioner has already pledged not to seek work for drug or device companies he’s regulated for four years after his tenure. “I’m not looking to make money. I’m looking to contribute to the development of effective” treatments, he said, adding: “I can’t speak for the rest of my life.” IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. The fine coat of tree pollen across the District is an unwelcome reacquaintance. Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim).
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