FDA LIST TIED TO CONTRACEPTION COVERAGE WOES — Payers and pharmacy middlemen are unfairly relying on a years-old FDA educational chart to limit access to new birth control methods that don’t yet have cheaper generic competition, manufacturers and contraceptive access advocates told Lauren. At issue is a chart developed by the agency to educate the public on more than a dozen FDA-approved contraceptive options that, over time, became entwined with federal guidelines spelling out how health plans could meet Affordable Care Act requirements aimed at providing free birth control to Americans. Guidance issued in 2015 made clear that plans were expected to cover at least one birth control method in 18 contraceptive categories the FDA had identified — language intended to prevent payers from agreeing to cover, say, birth control pills but not intrauterine devices. But over time, new drugs are at a disadvantage, advocates say, because they are either first-in-class products with no obvious category on the existing list or belong to an established class but boast unique formulations or dosages that could make them the first choice for patients, but not to payers trying to keep costs low. Patients and their providers can still petition plans to fully cover branded drugs if they’re deemed medically necessary, but the process is time-consuming. Federal agencies say they continue to receive reports of noncompliance and have threatened enforcement action against wayward plans. Payers say they already cover the vast majority of birth control options available to consumers and are within bounds to steer them toward cheaper generics while acknowledging the requirement to defer to providers who say certain branded drugs are necessary for certain patients. Manufacturers of newer contraceptive options suggest the tide is shifting in their favor now that the Supreme Court has overturned Roe v. Wade and raised questions about the future of the court’s longstanding precedents on birth control access. “These plans are denying women, not complying with what is a mandate, and they are making up interpretations to not provide women access,” Evofem CEO Saundra Pelletier, whose company makes a nonhormonal gel called Phexxi, told POLITICO. FORMER FDA CHIEF OF STAFF TO INDEPENDENTLY REVIEW TOBACCO OFFICES — Lauren Silvis, a former chief of staff at the FDA and senior adviser at HHS, has been tapped by the Reagan-Udall Foundation to lead an independent review of the tobacco regulatory programs at the agency, Katherine reports. Silvis will helm an expert panel that collects information about the Center for Tobacco Products, including anonymous input from staff, and develops recommendations for updating its premarket reviews, compliance and enforcement procedures. FDA Commissioner Robert Califf in July called for the foundation’s review of the tobacco, food safety and inspections programs following widespread criticism of the agency this year. A regulatory veteran: During her tenure as chief of staff, Silvis worked closely with former FDA Commissioner Scott Gottlieb. “Lauren helped lead the strategy around our efforts, including the comprehensive plan we announced to put nicotine at the center of our regulatory efforts, but also FDA’s enforcement strategy as the agency worked to curtail the youth abuse of vaping products,” Gottlieb told Prescription Pulse. “It’s an inspired choice,” said David Kessler, the chief science officer of the White House’s Covid Response team and another former FDA commissioner. “She cares deeply about the agency, and she’s extremely well positioned to bring the tobacco program toward the future.” And on the food side: Jane Henney, the Clinton-era FDA commissioner who was initially brought in to spearhead the agency’s external review, will focus on food safety. According to the foundation, Henney will evaluate the program’s leadership, structure, resources and culture.
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