We have a plan to reduce drug shortages: FDA’s Woodcock explains
In recent years, drug shortages have been a recurring problem. The latest list from the FDA totals nearly 70 medicines in short supply, including the Nasonex allergy drug and the Bystolic blood pressure pill. Hoping to better predict shortages before they happen, the FDA proposed new guidelines that could go into effect next year and require drug makers to provide specific data about their production facilities, including quality complaints, in advance or instead of inspections.
The agency claims this information will help root out the kinds of quality-control problems that lead to product shortages, but drug makers are irate. They argue the program will become expensive because most companies do not compile data uniformly. They also worry about the extent to which they are held responsible for contract manufacturers. And they complain there are penalties for not complying, even though the FDA says the program will be voluntary. We spoke with Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research, about the agency proposal and her reaction to industry concerns.