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Extended version: Widespread drug shortages spur FDA policy revisions

Agency responds to executive order with new rules for drug makers

The magnitude and frequency of drug shortages facing patients, health care providers and the pharmaceutical industry have made the problem too clear to ignore. A problem that wasn’t on the general public’s radar screens just a few years ago today is overtaking mainstream headlines and consuming the drug and health care industries as they struggle to address the problem.

According to an October 2011 Food and Drug Administration (FDA) report, drug shortages nearly tripled between 2005 and 2010, from 61 shortages annually to 178. Most of those shortages—80 percent—involved injection drugs including oncology drugs, antibiotics, and electrolyte and nutrition drugs. Take injectable cancer treatments: While their use has increased by around 20 percent, production capacity hasn’t grown correspondingly.

“This is a problem we can’t wait to fix,” President Obama said in an Oct. 31, 2011, statement as he signed an executive order directing the FDA to take further action to prevent and reduce drug shortages.

The FDA has responded by issuing new rules and working more closely with drug manufacturers and other parties.

The rule broadens a previous FDA interpretation—in the past, only manufacturers that planned to permanently discontinue the manufacturing and marketing of a drug were subject to mandatory reporting. Jensen says the rule puts companies on notice that the FDA wants to know if they’re going to discontinue a drug, and it wants to know as soon as they do.

The interim final rule became effective Jan. 18, and the agency will take comments on it until Feb. 17. Jim Czaban, who chairs Wiley Rein’s Food & Drug Law practice, says the rule itself is a “drop in the bucket” in terms of the regulatory burden on drug companies. He also believes it’s unlikely to change much in the short term.

Associate Editor

Melissa Maleske

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