FDA Considering Further Steps to Boost Generics Competition

FDA Commissioner Scott Gottlieb expanded on his drug competition action plan at a day-long agency meeting on generic competition.

To make the process more transparent, the agency is considering publicizing when it grants permission for brand-name companies to sell product samples of REMS-covered drugs to developers of generics.

Gottlieb called out companies that take advantage of FDA regulations to delay others from reaching the market. Publishing the agency’s direct correspondence with industry would give brand-name companies less public cover if they work to stall competition through the REMS process, and would inform broader discussions on generic access, he said.