US Government Keeps Lights On But Pharma Priorities For PBM Reform, Rare Diseases Nixed

The FDA will stay open, but its rare disease priority review voucher program will wind down after not being renewed on 20 December. PBM reform and other industry priorities also were nixed at the last minute in an effort to avoid a government shutdown.

US Capitol at sunset.
Congress narrowly avoided a government shutdown, but pharma priorities were cut from the bill. (Shutterstock)
Key Takeaways
  • Congress narrowly avoided shutting the US government down when it cleared funding legislation late on 20 December.
  • The final spending bill, which extends government funding through March, dropped key drug industry priorities, including PBM reform, pediatric and rare disease items and pandemic prep programs.
  • It is unclear whether Congress will revisit the issues in 2025.

The US Food and Drug Administration’s lights remain on, but pharma industry priorities were shut out in a spending bill cleared by the US Congress...

The spending bill ensured the US government avoided a shutdown during the holiday season, but the agreement to fund the FDA and other agencies through 14 March 2025 did not...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Legislation

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By 

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.

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.

More from Rare Diseases

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
• By 

Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.

EU HTA Regulation: ‘Stepping Beyond’ JCAs May Be Needed For Very Rare Disease Drugs

 

Cooperation between health technology assessment bodies across the EU will lead to a better joint clinical assessment process over time, but patients cannot afford a lengthy wait for improvements, speakers at a cell & gene therapy conference said.

US FDA Not Industry’s ‘Sock Puppet,’ Ultragenyx’s Emil Kakkis Says

 
• By 

The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.