Senators Ask FDA Commissioner What Help He Needs to Tackle REMS Abuse

Posted 26 June 2017 By Michael Mezher

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In a letter sent to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb last week, a bipartisan group of senators say they want to know what FDA can and cannot do to address certain tactics used to delay generic drug competition.

Gottlieb, who last week announced plans for a public meeting to gather insight on these practices, has signaled an interest to increase generic drug competition to reduce high drug prices in the US.

In the letter, the senators from the judiciary committee encourage Gottlieb to curb two ways drugmakers use FDA-imposed risk evaluation and mitigation strategies (REMS) to stall generic competition.

These tactics, which include preventing generic competitors from obtaining enough of a reference product sample to conduct bioequivalence testing and stalling negotiations to establish a single, shared REMS between the two companies, can create significant delays to bringing a generic to market.

According to the senators, there has only been one case of a generic and innovator company reaching agreement on a single, shared REMS before the approval of an abbreviated new drug application (ANDA), and in the 11 ongoing negotiations for shared REMS systems, "all but one … have missed at least one of the milestones set by the FDA."

In January, FDA waived the requirement for a single, shared REMS for generic versions of Xyrem (sodium oxybate) after negotiations between Jazz Pharmaceuticals and several generic drugmakers stalled for four years.

All eight of the senators that signed the letter are also sponsors of the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which if passed would allow generic drugmakers to bring action in federal court against drugmakers that restrict samples for bioequivalence testing and would make it easier for FDA to approve generics with separate REMS from the reference drug.

While Gottlieb has expressed interest in addressing both of these practices, Center for Drug Evaluation and Research Director Janet Woodcock told members of the House Committee on Oversight & Government Reform in March that FDA doesn't have the authority to require drugmakers provide their products to other companies.

Letter

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Categories: Generic drugs, Submission and registration, News, US, FDA

Tags: REMS, Generic Competition

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