(HealthDay News) — Drug makers would have to promptly notify the federal government of potential drug shortages under a new rule proposed Thursday by the U.S. Food and Drug Administration. The companies would be required to alert the FDA at least 6 months before a possible interruption in supply, or no later than 5 days after the interruption has occurred.
The FDA also released a two-part strategic plan to deal with drug shortages. First, the FDA will work to strengthen its own response to reported drug shortages while streamlining its internal processes and improving its ability to track medication supplies. Second, the FDA will work with drug manufacturers to develop long-term prevention strategies, including a review of production processes.
Medication shortages continue to pose problems for the U.S. health care system. For example, a recent survey found that four out of five cancer doctors encountered shortages of essential drugs in 2012, which affected the quality of care they provided and increased treatment costs.
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However, FDA Commissioner Margaret Hamburg, M.D., explained during a Thursday afternoon news conference that the FDA, in cooperation with drug manufacturers, has made significant progress in preventing shortages. “The number of drug shortages is now half what it used to be,” she said, noting that there were 251 drug shortages reported in 2011 but only 117 shortages in 2012.
