FDA'S PETITION REQUIREMENT FOR SEC. 515(b) RECLASSIFICATION REQUESTS IS CONTRARY TO FD&C ACT, LAWYER SAYS; FDA NOTES RULE WAS FINALIZED WITHOUT NEGATIVE COMMENT
This article was originally published in The Gray Sheet
Executive Summary
FDA goes beyond the statutory intent of the Food, Drug and Cosmetic Act in requiring that reclassification requests submitted in response to section 515(b) calls for premarket approval applications be in the form of petitions, attorney Larry Pilot (Washington, D.C. office of McKenna & Cuneo) says in a June 12 letter to the agency. "Although the term `request' is not defined in the Act, [FDA's] requirement for a `petition' clearly goes beyond the meaning that this statutory provision can bear," Pilot says.