More actions by GPhA and Obama Administration to address drug shortages

Following Congressional hearings in the fall, and an executive order from the White House on Oct. 31 (Pharmaceutical Commerce, Nov/Dec, p. 1), FDA and the drug-manufacturing community are more sensitized to the problem—but no immediate resolution is in sight. In the meantime, the Government Accountability Office (GAO) has weighed in with an evaluation of how FDA is handling the crisis, and finds that the agency “does not have a set of results-oriented performance metrics and strategic priorities related to drug shortages. As a result, FDA may be unable to effectively evaluate its work and improve its ability to protect the public health,” and is critical both of its current level of staffing to address drug shortages, and its ability to track and assess the information it is gathering.

Related to a Dec. 15 hearing on drug shortages at the Senate Committee on Health, Education, Labor and Pensions, FDA followed up the White House executive order with an interim final rule that all sole-source manufacturers of “certain critical drugs” report expected interruptions in manufacturing those products. (Some manufacturers are already required to do so; this will apparently expand the list, but will not include multi-source drug manufacturing.) In testimony, an FDA official said that since the Oct. 31 executive order, FDA has received 61 notifications, as compared to roughly 10 per month preceding the order.

Also at the hearing, Ralph Neas, president of GPhA, proposed an “Accelerated Recovery Inititative” (ARI), which would involve voluntary communication among manufacturers, distributors and GPOs to gather data on current and future supplies of drugs, then identify potential shortfalls. A third-party organization would handle the data collection. These data would then go over to an FDA “SWAT” team to respond to the looming shortage, using the techniques FDA’s Office of Drug Shortages staff: expediting FDA regulatory reviews; identifying other sources of supply and, as a last resort, allowing the importation of drugs from reliable sources internationally. GPhA is taking a lead in this because the majority of short-supply drugs today are generics, especially generic injectables commonly used in hospitals.