FDA’s Shutdown Plan: Some User Fee Services Would Continue; Routine Inspections Would Not

The agency would retain 8,180 staff members, about 55% of its total, mostly because they could be “paid from carryover funding.”

FDA would be able to continue some user-fee funded duties if the government is shut down Oct. 1, but would stop some facility inspections and other compliance activities.

The Department of Health and Human Services released its contingency plan Sept. 27 for its agencies in the event Congress does not reach an agreement on an appropriations...

More from United States

US Most Favored Nations Policy: Higher Drug Spending In Germany Is ‘Difficult To Imagine’

 

Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.

BIOSECURE Act Returning, Privacy, Gain-of-Function Bills Coming, Senate Sponsor Says

 

Legislation prohibiting work with certain Chinese biopharma firms will be reintroduced soon, Democratic Sen. Gary Peters said. And it will not be the only bill tied to international biotech competition and security concerns that will be considered.

Pharma DTC Ad Tax Break Targeted By US HHS, Congress

 

Health and Human Services Secretary Robert F. Kennedy Jr. said a policy that would remove the tax write-off for pharma advertising expenses would be coming in a few weeks.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

More from North America