“Citizen petitions” filed with the FDA are supposed to raise legitimate safety concerns. But my work has shown that nearly all are filed by brand drug firms and that the FDA denies more than 90 percent of them.
The FDA has offered draft guidance to address abusive citizen petitions. My comment applauds this attention and offers a friendly amendment that would make the proposed guidance stronger.
The FDA can summarily dispose of a petition if its primary purpose is to delay generic entry and it does not on its face raise a valid scientific/regulatory issue. Sounding good in theory, this power has never been invoked. I support FDA’s attention to elaborating the 1st factor of “primary purpose” of delay. But I suggest that this be linked with the 2nd factor, raising a valid scientific/regulatory issue.
I also support referring petitions filed for primary purpose of delay to FTC and Congress, and suggest that FDA provide additional detail in reports to Congress on which generics delayed, how delay is determined, and the length of delay.