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)

M&A:

• NorthShore University HealthSystem and Edward Elmhurst Health are reportedly in talks in merge. If finalized, the merger would create a nine-hospital network, including a behavioral health hospital, and give fast-growing NorthShore better access to patients in the western suburbs. Since its deal with Advocate Health Care fell through in 2017, NorthShore has added two additional hospitals –Northwest Community Healthcare and Swedish Hospital – for a total of six Chicago-area hospitals. (Article here)

Opioid/Substance Use Disorders:

• At least six states haven’t fully signed on to a proposed $5 billion settlement with Johnson & Johnson and a $21 billion settlement with major drug distributors McKesson Corp., AmerisourceBergen Corp., and Cardinal Health Inc. over their role in the opioid crisis. The deadline to agree to the settlements was over the weekend, but the Georgia attorney general’s office indicated talks are continuing. (Article here)

Payers:

• The Biden administration has delayed enforcement of key parts of a major insurer price transparency rule by six months until July 1, 2022, to give plans more time to comply. The CMS announced the change in a new guidance released Friday focusing on the final price transparency rule released last October under the Trump administration. The guidance focuses on a requirement that certain health plans disclose online their in-network provider rates for covered items and services, out-of-network allowed amounts, and billed charges for certain items and services. (Article here)