FDA issues REMS guidance to spur generic drug development

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FDA issues REMS guidance to spur generic drug development

By Sandra Levy - 04/05/2019
The Food and Drug Administration today issued a guidance entitled, "REMS: FDA’s Application of Statutory Factors in Determining When a Risk Evaluation and Mitigation Strategy," is necessary.

The guidance clarifies how FDA determines whether a REMS is necessary to ensure that the benefits of a drug outweigh its risks. It finalizes the draft guidance that was issued on Sept. 21, 2016.

“Today, we issued final guidance to clarify how the FDA applies six factors that impact the agency’s decision-making process regarding whether a REMS is required for a particular drug and what type of REMS might be necessary,” FDA commissioner Scott Gottlieb said.

While REMS are a critical tool designed to reinforce medication use behaviors and actions that support the safe use of that medication, Gottlieb said that some companies also try to game the system and use REMS to delay the entry of generics.

"When a generic drug applicant wants to market a generic version of a drug that has a REMS with Elements To Assure Safe Use, or ETASU – the brand and generic drug makers are required to develop a single, shared REMS program unless the FDA waives that requirement and permits the generic drug to use a different, comparable aspect of the ETASU," Gottlieb said.

The FDA recently posted a manual of policies and procedures regarding the development of a single, shared system REMS for a brand product and its generic equivalents to clarify how this process unfolds at the FDA.

Gottlieb continued, “In some cases, branded sponsors have refused to sell samples of brand products with REMS with ETASU impacting distribution of the drug to potential generic competitors. Generic drug developers need the samples of the brand drug to develop their generic product and to conduct testing to show that their product is bioequivalent to the brand drug for FDA approval. The FDA cannot stand idly by and allow companies to abuse the system, frustrating generic drug manufacturers and ultimately keeping patients from accessing lower-cost generic drugs. In May 2018, we first made available a list of companies that have potentially been blocking access to the samples of their branded products. Since then, we’ve updated this list once and will continue to do so to help deter companies from using REMS as an excuse.”

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