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Drug Importation Can Be Triggered By 'Excessive' Price Increases; Now US FDA Has To Decide What That Means

 
• By Michael Cipriano

Did FDA Commissioner Scott Gottlieb and HHS Secretary Alex Azar have a change of heart on importation? Or are they being pressured from above?

Chair on Fire

The move by the US FDA and the Department of Health and Human Services (HHS) to explore the creation of a temporary, narrow drug importation program targeting sole-source products that are off-patent and off-exclusivity generates questions both practical and philosophical for drug sponsors.

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More from Pricing Debate

Europe Should Pay Drug Prices More In Line With US, Two Pharma CEOs Argue

 
• By Kevin Grogan

Sanofi's Paul Hudson and Novartis's Vas Narasimhan claim that while Europe is home to some of the most important biopharma companies in the world, its position is in jeopardy.

Proposed HHS Budget Would Eliminate Medicare Negotiation Program Start-Up Funding

 
• By Cathy Kelly

The preliminary budget document supports legislation clawing back funds appropriated for the program.

Medicare Price Negotiation: Trump Order Adds Momentum To ‘Pill Penalty’ Fix

 
• By Cathy Kelly

Wide-ranging executive order to lower drug prices also hints at changes in upcoming guidance on the Medicare price negotiation program but few other potentially impactful near-term actions.

New Medicare Negotiation Program ‘Iterations’ Inevitable, Former CMS Official Blum Says

 
• By Cathy Kelly

Jonathan Blum, who was principal deputy administrator during the Biden Administration, explained the agency’s approach to setting up the price negotiation program and said changes likely will be implemented by the Trump Administration.

More from Market Access

Proposed HHS Budget Would Eliminate Medicare Negotiation Program Start-Up Funding

 
• By Cathy Kelly

The preliminary budget document supports legislation clawing back funds appropriated for the program.

Industry Highlights Issues With EU HTA Regulation’s PICO Framework For Vaccines

 
• By Eliza Slawther

Vaccine developers should be aware that the framework underpinning the new EU Health Technology Assessment (HTA) Regulation might not be suitable for immunizations, but actions from policymakers and industry could help mitigate some issues, a senior figure from GSK says.

EU HTA Regulation: Don’t Forget About Vaccines, Industry Warns

 
• By Eliza Slawther

Europe’s vaccines industry wants to make sure immunizations “are not forgotten” by policymakers who are overseeing the EU Health Technology Assessment Regulation. It has highlighted several nuances of vaccines that should be addressed over the coming years.