September 1, 2021
Life Sciences
  • Two senior vaccine regulators at the FDA who helped lead its review of COVID-19 vaccine applications will leave the agency this fall. Their departures come as the agency remains without a permanent commissioner and could interrupt its work on COVID-19 vaccines. Dr. Peter Marks, director of the FDA’s biologic center, said the search for a new vaccine office director will “begin imminently.” (Articles here, here, and here)
  • Senate Democrats’ prescription drug bill, which would allow the federal government to negotiate prices, may not apply to people with employer-based health insurance. The Senate’s “Byrd rule” requires that provisions have a sufficient impact on the federal budget. Because lowering drug prices for people with private insurance does not have as direct of an impact on the federal budget as lowering prices with Medicare, Senate lawmakers may narrow the scope of the measure to ensure it can pass the Senate through the budget reconciliation process as part of Democrats’ $3.5 trillion spending package. (Article here)