August 24, 2021
Life Sciences
  • The FDA granted full approval to the Pfizer-BioNTech COVID-19 vaccine for people 16 and older, making it the first shot to gain full approval. The vaccine will be marketed as Comirnaty. President Joe Biden said the move should clear up any doubts over the shot’s safety and efficacy. The announcement triggered a wave of vaccine mandates, including the Pentagon, CVS Health, and New York City schools (for teachers and staff). Additional hospitals, schools, employers, and other groups are expected to follow suit. (Articles here, here, here, here, here, and here)
  • The FDA and the drug industry agreed to launch several new pilot programs to help get drugs approved quickly for rare medical conditions as part of the user fee update. The existing agreement expires next month. Congress must approve the new deal before the FDA can make the changes. (Article here; Commitment letter here)
  • A bipartisan group of senators is probing potential conflicts of interest in the FDA’s work with McKinsey and Co. In a letter, the senators say that the consulting firm helped businesses sell prescription painkillers and advised opioid manufacturers on avoiding regulatory oversight while also working with the FDA, which has paid McKinsey more than $140 million since 2008. The senators asked for more information from the FDA by September 20. (Article here)