Manufacturers are required to report information about shortages to FDA, and are required to report the reasons for shortages and the expected duration of shortages on the FDA website. Title X of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, signed on July 9th, list the mandatory reporting requirements for manufacturers.
FDASIA provides FDA with important new authorities that will help the Agency to further combat drug shortages. Some of the enhanced authorities are as follows:
FDASIA broadens the scope of the early notification requirement by requiring all manufacturers of covered drugs to notify FDA of potential discontinuances. The prior law applied only to sole manufacturers.
FDASIA makes clear that manufacturers are required to report discontinuances to FDA regardless of whether they intend to discontinue the product permanently or are facing only a temporary interruption of supply.
FDASIA enables FDA to require, by regulation, mandatory reporting of shortages of biological products. The prior law excluded all biological products from the reporting requirements.
FDASIA makes clear that the notification requirement applies to drugs that are used in emergency medical care or during surgery (if they are intended for use in the prevention of a debilitating disease or condition).
FDASIA requires FDA to issue a non-compliance letter to manufacturers who fail to comply with the drug shortage notification requirements and to make the letter and the company’s response to the letter available to the public.
