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

US FDA’s Most Unusual Advisory Committee

 
• By Laura Helbling and Michael McCaughan

Agency's opioid response efforts have pushed advisory committee into unusual territory in recent years. But a two-day meeting to discuss potential labeling changes to recommend co-prescribing of the overdose reversal agent naloxone moved way beyond any of the conventional boundaries of committee meetings.

FDA Advisory Committee Feature image

The Dec. 17-18 joint meeting of the US FDA’s Anesthetic & Analgesic Drugs Products and Drug Safety & Risk Management Advisory Committees was probably the single most unusual and creative use of the advisory committee format by the agency’s new drug review center.

The formal discussion topic was itself unusual, but well within the boundaries of advisory committee fare: whether FDA should consider...

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

Payment Cap Not Always Solution For Unaffordable Drugs, Maryland PDAB Director Says

 
• By Cathy Kelly

The state's Prescription Drug Affordability Board, the oldest of a growing list of the boards, chose six drugs for affordability reviews and has the authority to set a ceiling on the amount state and local government payers would reimburse for them.

New Pricing Agreements And Greater Transparency: What A US MFN Policy Could Mean For France

 
• By Francesca Bruce

A potential MFN drug pricing policy in the US could also lead to a greater push for collaborative action in the EU, such as joint procurement among the member states, says one European industry expert.

US ‘Most Favored Nations’ Drug Pricing Policy Will Jeopardize Innovation In Europe

 
• By Francesca Bruce

The US MFN executive order is the latest in a series of concerning US developments that are contributing to uncertainty for the European pharmaceutical industry, according to France Biotech’s vice president, Alexandre Regniault.

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By Lisa Takagi

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.

More from Market Access

Saving Part D: US Medicare Advisors Sound The Alarm

 
• By Michael McCaughan

The US Medicare Payment Advisory Commission worries that Medicare prescription drug market trends may cause the stand-alone plan portion of the program to “wither away,” which could take the traditional fee-for-service side of Medicare with it.

US ‘Most Favored Nations’ Drug Pricing Policy Will Jeopardize Innovation In Europe

 
• By Francesca Bruce

The US MFN executive order is the latest in a series of concerning US developments that are contributing to uncertainty for the European pharmaceutical industry, according to France Biotech’s vice president, Alexandre Regniault.

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By Lisa Takagi

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.