CALIFF FDA PRIORITIES — New FDA commissioner Robert Califf was sworn in Thursday to lead the agency where he’ll face a number of challenges. My POLITICO colleagues this week laid out six key issuesfor Califf, including what will happen to tests and treatments under emergency authorization once the public health emergency expires, as well as matters surrounding user fees, opioids, abortion pills and tobacco regulation. Califf, confirmed by a 50-46 vote Tuesday for his second go-around atop the agency, unveiled his priorities Thursday in a tweet thread from his new Twitter account. With misinformation about Covid-19 running rampant, Califf said it would be key to push back against misinformation about science and the agency. “These kinds of distortions and half-truths that find their way into the public domain do enormous harm, both by leading people to behavior that is detrimental to their health,” Califf wrote. Some other priorities he cited included: — The Covid-19 pandemic response —Accelerating development of new treatments and devices — Lessening harm from tobacco and stopping young people from using “harmful tobacco products, including e-cigarettes” “At the core of all of these issues is the fundamental need to enhance our ability to collect and analyze data,” Califf said. FTC PUNTS ON PBM PROBE — The Federal Trade Commission deadlocked in a 2-2 party-line vote Thursday about whether to probe the business practices of pharmacy benefit managers, or PBMs, a move that sends the commissioners back to the drawing board, POLITICO’s Leah Nylen and Megan R. Wilson report. Republican commissioners on the panel voted against a study because they said that, as drafted, it wouldn’t t consider key concerns, such as the impact of PBMs on out-of-pocket costs for consumers, but indicated they wanted to work with Chair Lina Khan to get a study “across the finish line.” Kahn said she was “disappointed by this outcome,” calling it a “life-or-death” situation. Voting for the review wouldn’t have launched a law enforcement action; instead it would have approved the development of a study from which information could be used to open investigations into certain companies. B. Douglas Hoey, CEO of the National Community Pharmacists Association, said in an emailed statement that “two members of the FTC just let the worst actors in the market off the hook.” The largest players in the PBM space — CVS Caremark, Express Scripts and OptumRX — represent nearly 80 percent of the market and are either owned by or own insurance companies. The trio also represents three of the four largest U.S. pharmacies by prescription drug revenue. In a statement after the vote, the Pharmaceutical Care Management Association — which represents PBMs — pointed the finger at drugmakers for high prescription prices. “PBMs are holding drug companies accountable by relentlessly negotiating the lowest possible cost on behalf of patients, and are driving and delivering local competition that patients are demanding,” Greg Lopes, a spokesperson for the group, said in an emailed statement. NEWSOM STRATEGY — California Gov. Gavin Newsom laid out a strategy Thursday for the "next phase" of tackling Covid-19 in the state, a plan focused on detecting variants early, bolstering high-quality mask supply and obtaining rapid tests, POLITICO's Victoria Colliver reports. A 30-page document detailing the approach doesn’t include the word “endemic.” The plan’s goals are to “keep schools open and children safely in classrooms.” The effort doesn’t have metrics or goals to trigger certain approaches but has levers to pull when variants or surges arise. “We’re announcing what I like to call response metrics that, if we need them, these are going to be what keeps us ready for the future,” California’s Health and Human Services Agency Secretary Mark Ghaly said. Backdrop: California is among several Democratic-controlled states rethinking their approach to the pandemic and rolling back precautions as Omicron cases sharply decline. The CDC is also weighing updating its metrics guidelines, which states should look to when lifting public health measures like mask mandates.
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