Citizen Petitions at the FDA: Professor Lietzan Interviewed by The Atlantic

Professor Erika Lietzan was recently interviewed by a reporter for The Atlantic in connection with the use of “citizen petitions” at the U.S. Food & Drug Administration (FDA).

A recent article in the New England Journal of Medicine had pointed out that many petitions are filed by brand-name drug companies about products proposed by generic drug companies. Professor Lietzan commented that companies raising issues about their competition is not in itself troubling. She explained that petitions are a way to raise scientific and legal concerns with the agency and pointed out that the brand company may be the best positioned to comment on the science and manufacturing issues involved.

Professor Lietzan also questioned the conclusion that petitions in fact delay approval of generics, noting that the studies reaching this conclusion have drawn the inference simply from the fact that FDA issues its petition responses on the same day as it approves the generic drug.