Last week I summarized some of the recommendations for FDA in the first 67 comments to the Hatch-Waxman docket that opened in July. Today’s entry discusses the recommendations that relate to use and distribution restrictions, citizen petitions, and what some call “product hopping.”
Data exclusivity for drugs and biological products gets all the attention. (In fact, recently I read a law review article asserting that medical devices are not entitled to any sort of exclusivity period after approval. But this is wrong!) It is apparently not as well known, but sponsors of premarket approval applications (PMAs) enjoy six years of data exclusivity. Folks interested in FDA and innovation policy should know about the device scheme because it has a unique history (with a novel and clever – though unworkable – approach in place for seven years) and because at a high level it is still analogous to drug and biologic exclusivity even though the regulatory paradigms are different.