March 16, 2023
D.C. News | Tea Leaves
  • A new staff report from the Food and Drug Administration (FDA) says that Pfizer’s antiviral COVID-19 treatment, Paxlovid, is safe and effective at treating adults with mild to moderate COVID-19 who are at high risk of progressing to severe disease, including hospitalization or death. In addition, the report said the drug doesn’t cause patients to “rebound” after taking it. The report was released in briefing documents ahead of an agency advisory committee meeting where outside advisers will discuss whether to recommend Paxlovid for full approval. Paxlovid is currently on the market through an emergency use authorization granted in 2021. The FDA typically follows the advice of its outside panels but is not required to. (Article here)
  • Yesterday, the U.S. Centers for Medicare and Medicaid Services (CMS) said that the U.S. government will select the Medicare program’s 10 costliest prescription medicines based on gross spending for negotiating price cuts that will go into effect in 2026. CMS will only accept one formal written counteroffer during the negotiation process but will allow up to three additional in-person or virtual negotiation meetings, the agency said in initial guidance issued for its Medicare drug price negotiation program. (Articles here and here)