The Food and Drug Administration issued a draft guideline last month that would hold drug manufacturers liable for the activities of pharmacy benefit managers they own. The FDA wants PBMs to adhere to the same truth-in-advertising rules pharmaceutical companies must observe. The idea is to prevent PBMs from making misleading product claims.
PBMs would have to submit promotional materials to the FDA for approval, as drug makers already do. "Pharmaceutical manufacturers should not be permitted to avoid regulation by changing the form through which their communications are accomplished," an FDA official said. The comment period ends April 6.