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REMS Barriers: US FDA Takes 'Foundational Step' To Improve Generic Access

 
• By Brenda Sandburg

Generic firms might be able to purchase branded drugs for bioequivalence studies from Europe under concepts that FDA is considering. Commissioner Gottlieb says FDA may allow generic firms to seek wavier of shared REMS to avoid protracted negotiations. 

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US FDA Commissioner Scott Gottlieb is keeping a spotlight on the agency's efforts to curb brand company abuses of the Risk Evaluation and Mitigation Strategy (REMS) system that block generic entry.

In a Nov. 8 statement announcing FDA's release of a draft guidance for use of a single drug master file in a shared REMS submission, Gottlieb took the opportunity to emphasize that FDA is exploring new steps to reduce the likelihood that branded drug companies can use the existence of REMS to slow the entry of generic competition

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US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

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