In an otherwise familiar-sounding recitation of drug shortage causes and potential fixes, the Government Accountability Office identified in congressional testimony several plugs for the big holes in the FDA's shortage-prevention effort. As if on cue, the industry received notice of the agency's implementation of one of the plugs--in the form of an interim final rule--and a drugmaker association issued notice of its own shortage-fighting initiative (see related story).
The FDA rule will require manufacturers that are the only producer of certain critical drugs to report to the FDA "all interruptions in manufacturing" of those products. President Obama's Halloween executive order aimed at reducing the number of drugs in short supply was the impetus for the rule.
The FDA has been constrained in its ability to prevent shortages by the lack of authority to require the early warning, according to congressional testimony by GAO director for health care Marcia Crosse. In addition, the agency lacks authority to require drugmakers to take "actions to prevent, alleviate, or resolve shortages."
Crosse's testimony was based on a just-released GAO report, which finds that the FDA "can prevent the majority of shortages ... when it learns of potential supply disruptions in advance."
Crosse identified another of the holes: the FDA's lack of a drug shortage database. "FDA is unable to systematically monitor trends and enhance its ability to address the causes" because of the absence of such a database. Also lacking is a set of "results-oriented performance metrics related to drug shortages."
Significantly, the GAO finds that the FDA hasn't named drug shortage prevention among its strategic priorities.
- here's the release on the interim rule
- see the HHS fact sheet
- here is Crosse's prepared testimony
Special Report: Top drug shortages by treatment category