Citizen petitions next in the firing line to stop generics delays

Scott Gottlieb, the Commissioner of the US Food and Drug Administration (FDA) and the man with the plan to increase competition in his country’s pharmaceuticals market, has announced a new prong to the agency’s attempts to stop ‘gaming’ of the generic drug approval process.

Since announcing the Drug Competition Action Plan in June 2017, one of Dr Gottlieb’s major steps to stop these practices used by branded firms to ‘game’ the system has been to focus on companies that are making it hard for generic manufacturers to get access to physical doses of a branded drug, making comparison studies difficult and slowing the development of copies.

Now Dr Gottlieb has made a statement saying that another anticompetitive technique that concerns him relates to section 505(q) of the Federal Food, Drug, and Cosmetic Act. Many of these petitions are filed by pharma companies as a way of fighting off generic competitors, raising concerns with the copies that take the FDA time and resources to answer, thereby delaying the approval process.