1. Pink Sheet
  2. >>Legislation
  3. >>Elections

Gottlieb Renews Call For New Opioid Review Paradigm As Democrats Prepare For House Control

 
• By Michael Cipriano

US FDA's controversial approval of Dsuvia may prompt incoming House Democrats to pay special attention to commissioner's remarks on how agency reviews opioids. 

Medical advice and medication guidance and prescription drugs health consultation as a giant pill shaped as a lighthouse beacon with 3D illustration elements.

US FDA Commissioner Scott Gottlieb renewed his pitch for the agency to adopt a new paradigm for reviewing future opioid applications on the heels of the controversial Dsuvia (sufentanil sublingual) approval during a Nov. 8 speech, although this time he likely has a new audience listening: the upcoming Democrat-controlled House of Representatives.

Speaking at a private National Comprehensive Cancer Network (NCCN)/American Society of Clinical Oncology (ASCO) workshop, Gottlieb reiterated his desire to see FDA adopt a review model for opioids that not only assesses their individual risk/benefit profiles, but evaluates them against existing opioids on the market, according to the prepared remarks

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 Elections

US Tariff Impact On Korea Dissected As Country Gears For Presidential Election

 
• By Jung Won Shin

Analysts expect a limited impact on South Korean pharma from US tariffs, even if imposed at a later date. Meanwhile, the early June domestic presidential election is set to determine the direction of policies in the sector.

‘A Lot Of That, It’s Meant To Start A Conversation’: How To Work With Trump

 
• By Alaric DeArment and Jessica Merrill

Biotech execs and lobbyists try to explain the Trump Administration's policy strategy and how to thrive in it.

Bracing For RFK At HHS: Vaccine Safety Commission Likely First Step

 
• By Michael McCaughan

Robert F. Kennedy Jr. will become HHS secretary while retaining his anti-vaccine positions. His first action likely will be creating a new safety commission, which industry must hope holds off more drastic action.

Trump And Tariffs Top Generic Industry Concerns

 
• By Dave Wallace

At a lively AAM Access! conference in Florida, AAM President and CEO John Murphy acknowledged the negative effects of potential tariffs, but also suggested that the second Trump Administration could be an opportunity for the generics and biosimilars sectors to advance market reforms.

More from Legislation

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
• By Eliza Slawther

European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.