Influential Panel Backs Expanded Range Of HIV Prevention Drugs
The U.S. Preventive Services Task Force gave its highest or “grade A” recommendation to three medications approved for PrEP. Just one pill was previously endorsed, and the move may require private insurers to cover the drugs without a co-pay or deductible under the Affordable Care Act.
The New York Times:
Expert Panel Recommends New Drugs For HIV Prevention
An influential expert panel has given its highest recommendation to an expanded menu of H.I.V. prevention strategies for adults and adolescents, a move that will require private insurers to cover the drugs without a co-pay or deductible under the Affordable Care Act. The recommendation arrives as the Biden administration is fighting to preserve no-cost coverage of all preventive services under the A.C.A., after a Texas judge ruled the mandate to be unconstitutional. (Mandavilli, 8/22)
NBC News:
Insurers Must Cover Injectable HIV Prevention Drug — Unless Courts Void Mandate
By law, insurers now have until January 2025 to begin widely covering Apretude. But the requirement could be nullified by a lawsuit pending in the 5th U.S. Circuit Court of Appeals. The suit is being waged by a group in Texas, many members of which are self-described Christian business owners, who oppose covering PrEP on religious grounds. In September, a U.S. district judge in Texas agreed that the plaintiffs’ religious freedom had been violated and ruled that the health task force had no constitutional authority to dictate insurance policy, because its members were not appointed by the president or confirmed by the Senate. The ruling has been stayed pending appeal. (Ryan, 8/22)
In news from the FDA —
Politico:
Califf Urges Congress To Give FDA More Power To Respond To Drug Shortages
Congress should grant the FDA more authority to address drug shortages, Commissioner Robert Califf said Tuesday. The domestic generic drug industry is a victim of its own success, with product prices too low to sustain quality manufacturing and distribution, Califf said during a webinar hosted by the Alliance for a Stronger FDA, which advocates for agency appropriations. (Gardner, 8/22)
Reuters:
US FDA Panel Backs Otsuka's Blood Pressure Treatment Device
A panel of advisers to the U.S. Food and Drug Administration (FDA) on Tuesday recommended the use of a device made by a unit of Otsuka Holdings (4578.T) in a type of surgery to treat high blood pressure. The FDA panel backed the use of the device made by the Japanese company's unit ReCor for renal denervation, which is indicated for use in patients whose hypertension, or high blood pressure, cannot be controlled with drugs. (Roy, 8/22)
Stat:
FDA Advisory Panel To Debate High Blood Pressure Devices
An advisory committee to the Food and Drug Administration will convene on Tuesday to evaluate the benefits of renal denervation, a one-time surgical procedure that works to reduce blood pressure. The promise — and the potential market — is enormous, but the data on how well the procedure works remains contentious. (Lawrence, 8/22)
Politico:
FDA Warns Amazon, Walmart And Others Over Unapproved Drug Products
The FDA has issued six warning letters, including to retail giants Amazon and Walmart, for selling unapproved products online that target a skin condition common in children. The warnings, posted Tuesday to the agency’s website, require the companies to respond within 15 days with evidence that they are no longer selling the products or that their sale doesn’t violate FDA rules. The FDA says non-compliance could prompt the agency to take further action. (Gardner, 8/22)
