FDA chief to big pharma: ‘End the shenanigans’

FDA commissioner Dr. Scott Gottlieb yesterday scolded pharmaceutical companies that employ tactics to stifle generic drug competition, calling on them to “end the shenanigans.”

At this week’s Federal Trade Commission meeting on competition within the pharmaceutical industry, the FDA chief called out brand-name pharma companies for trying to extend negotiations over risk evaluation and mitigation strategies, or REMS, to stall generic companies from buying a product to run bioequivalence studies.

On Wednesday, the FDA issued draft guidance aimed at streamlining the submission and review process for shared system REMS. Gottlieb said he hopes that this effort will counter practices occasionally undertaken by brand-name companies to delay the REMS process.

“Currently, under a shared system REMS, multiple applicants need to coordinate the submission of identical REMS-related documents for their respective applications. This draft guidance explains the FDA’s current thinking that the use of a single Drug Master File (DMF) for shared system REMS submissions will allow manufacturers with products in shared system REMS programs to submit one collective set of files to the agency. This is a first step toward additional actions FDA plans to take to making sharing a single REMS easier,” he said, according to RAPS.

“Our goal is to see sponsors share REMS systems to reduce burdens on providers. But when branded drug makers drag out these negotiations – sometimes as a way to forestall generic entry – we’re going to be in a stronger position now to say enough is enough,” Gottlieb reportedly added.

Panelists at Wednesday’s FTC meeting discussed other tactics used by brand-name companies to prevent generic products from getting to market, including pay-for-delay schemes and product hopping.

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