The Food and Drug Administration announced on Oct. 31 two initiatives aimed at cutting down on drug shortages and improving communications with drug companies.
The first is a proposed rule to require drug manufacturers to alert the FDA if certain "medically important drug products" are running low, Dr. Margaret Hamburg, commissioner of the agency, said during a teleconference announcing the initiatives. This proposal expands on early notification requirements included in the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), which created a task force designated to deal with drug shortages. The proposal also would extend those requirements to biologically manufactured drugs.
Dr. Margaret Hamburg
The second initiative is a strategic plan to improve communications between the FDA and drug manufacturers, develop short- and long-term contingency plans for drug shortages, and revamp communications processes within the agency to improve response times to potential shortages.
The strategy was developed with both internal and external input and analysis from work groups, drug manufacturers, and health care organizations. For the plan to work "this has to be a group effort," Dr. Hamburg said.
Drug shortages have declined significantly since 2012, with 117 drug shortages in 2012, down from 212 in 2011. But early notification from manufacturers about possible shortages can help drive those numbers down even further, said FDA representatives.
The strategic plan, which was required by FDASIA and is being sent to Congress Oct. 31, also includes new ideas such as the development of a smartphone app for real-time drug shortage news, a proposal for rewarding drug manufacturers based on cooperation with the FDA, and a new office within the Center for Drug Evaluation and Research focused exclusively on pharmaceutical quality.
Members of the public may comment on the proposed rule, which is scheduled to be published in the Federal Register on Nov. 4.