Press Announcements > Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions

Press Announcements > Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions

When I announced the Drug Competition Action Plan, or DCAP, in June 2017, I committed the FDA to a number of new steps to increase competition in the market for prescription drugs and to help facilitate the entry of lower-cost alternatives to improve patient access to affordable medicines.

One area of focus has been shutting down practices used by branded firms to “game” the system and take advantage of certain rules, or exploit loopholes, to delay generic approval – thereby extending a drug’s monopoly beyond what Congress intended. One of the most common tactics we’ve taken aim at are instances when branded firms make it hard for generic manufacturers to get access to physical doses of a branded drug. Generic manufacturers need anywhere from 2,000 to 5,000 doses of the branded drug in order to run studies to prove their generic medicine is the same as the branded drug. Such practices upset the careful balance that Congress sought between product innovation and access. They can make the development and approval process unpredictable, and potentially more costly, for generic manufacturers.