The FDA’s Role in Dealing with Drug Shortages

When Ameridose, the company linked to the recent meningitis outbreaks and production of contaminated steroid injections closed its doors for the remainder of the year, many people worried about drug shortages. Since then, the FDA has been working to offset the drug shortages produced by the closing of Ameridose.

The FDA sees its role in dealing with drug shortages as a high priority, understanding that these medications are needed by people to stay healthy and treat illnesses. The administration reports the number of medications in short supply was 251 in 2011. In 2012, the FDA worked with drug manufacturers to deal with shortages of 145 drugs.

In regards to the closing of Ameridose and its lack of drug production, the FDA is taking the following steps:

  • The administration is working with manufacturers of drugs previously supplied by Ameridose, requesting them to increase production if they are able.
  • The FDA is offering assistance to any drug manufacturers that are having production problems to ensure production is of safe and high quality.
  • The FDA will continue to expedite the reviews of any pending applications that may assist with addressing drug shortages.
  • The FDA is identifying additional manufacturers willing to produce drugs in short supply.
  • If needed, the FDA will explore overseas companies that are willing and able to import medications to aid in the shortage.

In an FDA Voice post by Margaret A. Hamburg, M.D. and Commissioner of the FDA, Hamburg writes, “[w]e at FDA are committed to doing everything we can, using all available tools, to prevent or mitigate drug shortages and help keep critically needed products on the market.”

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