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Gottlieb: Branded Industry 'Gaming' Tactics Have Shifted From Regulatory To Commercial Space

 
• By Michael Cipriano

US FDA's focus on areas such as REMS abuse may have prompted certain brand sponsors to shift their focus to the commercial space to keep generic competition off the market, former commissioner Scott Gottlieb tells the Association for Accessible Medicines.

Scott Gottlieb
Scoot Gottlieb feels that the US FDA's efforts to stop certain brand firms from gaming the system to block generics have at least shifted the playing field even if they haven't eliminated the problem.

A notable focus of the US Food and Drug Administration during the tenure of Scott Gottlieb centered on the regulatory "gaming" tactics used by branded industry to prevent generic competition from reaching the market. But many of those tactics have now shifted to the commercial space, the former agency commissioner said.

Speaking at the Association for Accessible Medicines' GRx+Biosims 2019 meeting on 6 November, Gottlieb contended that innovators have mostly moved on from strategies such as abuse of risk evaluation and mitigation strategies (REMS) to prevent the sale of branded samples to generic developers, and have

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