Help on the way? A generic drug deal

Two distinct efforts to combat increasing U.S. drug shortages are in the works. Recently, a bipartisan group of senators has introduced a bill that calls for drug manufacturers to alert the FDA to any impending shortages, which would then theoretically allow the agency to begin seeking alternatives. Perhaps more promising is a compromise agreement that has just been reached between the FDA and generic drug makers. The agreement, if approved by Congress, would instate a user-fee program that would accelerate drug approvals. The idea is that generic companies would pay fees that would allow the FDA to hire more staff and improve support systems in its drug review process.

While not directly addressing the drug shortage, a program that would simultaneously accelerate the approval process and improve regulatory inspection could have a modest impact on the availability of drugs that are currently hard to come by. Unquestionably, says ACSH's Dr. Josh Bloom, this program should encourage more companies to jump in and fill some of the many gaps in drug availability, but this in no way ensures that the problem will be fixed.