1. Pink Sheet
  2. >>Market Access
  3. >>Pricing Debate

FDA User Fee Bills: Is It Possible For Reauthorization To Be Too Clean?

 
• By Michael McCaughan

First draft of user fee omnibus bill is about as 'clean' as a bill can be – free of the policy riders that have always been attached to US FDA funding legislation in past cycles. That is good news for industry, which is eager to see the program reauthorized with as little drama as possible, but could the bill actually be too clean?

Capitol House

The first “discussion draft” version of the FDA user fee legislation is breathtaking in its simplicity: a straightforward reauthorization of the funding programs already negotiated for the brand (PDUFA), generic (GDUFA), biosimilar (BsUFA) and medical device (MDUFMA) industries.

The bill also includes reauthorization for a handful of other expiring programs at FDA. And that’s it. None of the...

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
Start Free Trial

Already a subscriber?

More from Pricing Debate

Initial Medicare Price Offer For Ozempic, Wegovy Almost Half Off Net, Analysis Suggests

 
• By Cathy Kelly

Only Bausch Health’s Xifaxan may have had a lower initial offer among the 15 drugs in the current Medicare price negotiation round, researchers at the University of Washington and the University of California, San Diego, projected.

German Pricing System Is Tougher On Drugs Targeting Smaller Patient Populations

 
• By Francesca Bruce

The proportion of AMNOG benefit assessments leading to a positive rating, which has a direct impact on drug pricing, has decreased in recent years, according to analysis from the VFA, the association representing the German pharmaceutical industry.

Pink Sheet Podcast: US FDA Involved In Drug Pricing Deal, DOJ’s Off-Label Promotion Policy

 
• By Derrick Gingery, Sarah Karlin-Smith, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the FDA’s role in the Astra Zeneca Most Favored Nation drug pricing deal and the Justice Department interpreting the off-label promotion laws differently than the FDA.

EMD Serono IVF Candidate Among First US FDA Priority Voucher Recipients As Part Of MFN Deal

 
• By Cathy Kelly

A combination of two individual IVF treatments, Pergoveris has the potential to be a lower cost option in the US, one of the qualifications the FDA wants in a National Commissioner's Priority Voucher candidate.

More from Market Access

EMD Serono IVF Candidate Among First US FDA Priority Voucher Recipients As Part Of MFN Deal

 
• By Cathy Kelly

A combination of two individual IVF treatments, Pergoveris has the potential to be a lower cost option in the US, one of the qualifications the FDA wants in a National Commissioner's Priority Voucher candidate.

UK Must Make ‘Strategic Choices’ To Free Up Money For Medicines, ABPI Chief Says

 
• By Eliza Slawther

The UK’s commercial environment is “incredibly strained,” meaning that there is little money left to pay for innovative medicines. The ABPI’s chief executive says a “fundamental transformation” will be required to drive necessary changes.

340B Rebate Model Stalls As Medicare Negotiated Price Implementation Approaches

 
• By Cathy Kelly

The US government shutdown is challenging HRSA’s ability to advance the 340B pilot program on schedule.