August 10, 2012
Generic Drug Industry Proposal to Address Drug Shortages Gets FTC Approval
The Generic Pharmaceutical Association (GPhA) received a Federal Trade Commission (FTC) Advisory Opinion permitting a plan to address drug shortages to move forward. The GPhA’s plan is titled the "Accelerated Recovery Initiative (ARI)," and it would operate by generic drug manufacturers communicating production details of critical drugs to health care technology company, IMS Health. This information would be pooled together with other IMS Health market data and then shared with the Food and Drug Administration. Reportedly, with this information, the FDA would have a comprehensive real time view of drug production in the generic market place and could work more quickly and efficiently to avert shortages.
The announcement of the FTC's Advisory Opinion citing no antitrust violations with this ARI plan comes in the wake of the recently passed "Food and Drug Administration Safety Act," which placed a high value on enhanced notification of drug shortages.