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FDA Outlines Plan to Combat Drug Shortages
The FDA has released a strategic plan that outlines the tools the agency has available to prevent or resolve drug shortages and details long-term solutions. Actions that drug manufacturers and others can take are also detailed in the plan.
In July 2012, Congress broadened manufacturers’ reporting requirements with regard to potential drug shortages. Consistent with the new law, the FDA is proposing to require that all manufacturers of certain medically important drugs give the agency at least 6 months’ notice, or as far in advance as practical, if they intend to discontinue making a drug or learn of manufacturing problems that are likely to affect supply.
Previously, notice was required only from manufacturers of certain critical drugs that were not made by one or more other companies.
In addition, the new rule would impose the same requirement on manufacturers of certain medically important biological products, which include therapies made from living organisms, such as cells, rather than the chemical compounds used in drugs.
In 2006, 56 drugs were in short supply. The number grew every year until it reached a record high of 251 drugs in 2011. Then, in 2012, the number dropped to 117. Numbers for 2013 are not yet available.
Among the shortages addressed last year were a cancer drug used to treat childhood leukemia and osteosarcoma, and a drug used for ovarian and other cancer regimens.
Manufacturing issues involving quality or capacity are the most common reasons for drug shortages. These issues can be particularly problematic for sterile injectable drug products, which require a specialized manufacturing process. Other factors include a lack of raw materials, increased demand, and a company’s business decision to stop making older, less profitable drugs.
Source: FDA; October 31, 2013.