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FDA and Manufacturers Work to Prevent Drug Shortages
Manufacturers can play a critical role in decreasing the impact of shortages of medically necessary drugs by reporting to the FDA changes in production that might impact their ability to supply the market. The FDA’s Drug Shortage Program—within the Center for Drug Evaluation and Research (CDER)—strives to prevent shortages and mitigate their impact on the public by working with manufacturers and others within the agency.
According to data collected by the FDA’s Drug Shortage Program, there were 178 drug shortages in 2010, nearly triple the level of 61 shortages recorded in 2005.
This year continues to show an increasing number of shortages, especially among sterile injectable drugs, almost all of which are categorized as medically necessary. The agency considers a drug medically necessary if it is used to treat or prevent a serious disease or medical condition, and there is no other source or alternative drug available.
“Several different factors are contributing to the current shortage of sterile injectables and other drugs,” says Valerie Jensen, associate director of CDER’s Drug Shortage Program. “Some firms decided to discontinue making their products for business reasons, others had problems with their raw materials suppliers, some had quality and manufacturing problems, and some were hit with an increased demand.”
In 2010, quality and manufacturing problems were a major reason for shortages.
“A company experiencing manufacturing problems often voluntarily halts production in order to resolve the root cause of product quality problems,” said Ilisa Bernstein, deputy director in CDER’s Office of Compliance. “FDA understands that quality and manufacturing issues can be complex and may require a significant amount of time to correct.”
Drug companies are responsible for ensuring the quality and safety of the drugs that they manufacture. FDA works with companies when they experience problems with quality or sourcing of supplies needed to manufacture a drug in order to prevent or mitigate a shortage.
Companies are required to inform FDA six months in advance of discontinuation of sole source, medically necessary drugs. Although not currently required, FDA encourages companies to provide notification of any issues that could lead to a shortage. FDA also encourages companies to have redundancy in their manufacturing, raw material, and component suppliers. This strategy helps to ensure that if something goes wrong, companies have a back-up plan. FDA is available to discuss with industry contingency plans for additional manufacturing sites, production lines, and suppliers to help prevent shortages of medically necessary drugs. Additionally, FDA stands ready to meet with new companies interested in making drugs that are vulnerable to shortage.
“Good agency-industry communication can facilitate resolution of a drug shortage. FDA is committed to working with industry to quickly resolve any quality or manufacturing problems that arise to ensure continued patient access to vital safe and effective medicines,” says Jensen.
For more information on drug shortages, visit the FDA Web site at http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm.
For information on reporting a drug shortage, please see http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm142398.htm.