Regulatory Focus™ > News Articles > Report: Drug Shortages Abating Thanks to FDA Efforts

Report: Drug Shortages Abating Thanks to FDA Efforts

Posted 10 September 2012 | By Alexander Gaffney, RAC 

In at least one respect, 2011 was not a banner year for the US Food and Drug Administration (FDA): drug shortages. While the agency managed to approve 35 new drugs, 267 were in short supply at one point during 2011, according to information released by the University of Utah Drug Information Service (DIS). But that trend may be changing for the better, reports NBC News.

Compared to the same time in 2011, there have been approximately a third fewer drug shortages during 2012, reported NBC relying on information supplied by DIS. When drug shortages did occur, they typically lasted for a shorter period of time, DIS said.

The NBC report largely credits FDA for the decline in shortages, saying its attempts to decrease the number and duration of shortages have succeeded in fostering an environment in which regulators can work with manufacturers to solve quality and manufacturing issues. FDA's Drug Shortage Program (DSP) lists 52 drugs that have had their shortage situations solved during 2012, with the agency moving to circumvent shortages of others through use of enforcement discretion.

Additional rules by both FDA and the Obama administration have further clamped down on shortages, requiring single-source drug manufacturers to alert FDA to shortages when they are made known to the manufacturer.

Expected Progress

The progress is not unexpected, according to remarks made in June at the American Society of Clinical Oncology (ASCO) annual meeting. "The good news is the frequency of drug shortages has begun to decline," said Richard Schilsky, head of government relations for ASCO. Cautioned ASCO President Michael Link, "We're not out of the woods yet."

Sandra Keweder, deputy director of CDER's Office of New Drugs, has also cautioned that it may be, "Several years before companies building new plants get them up and running," meaning shortages may be persistent for some time.

Heated Debate

The exact cause of the drug shortages has also been the topic of heated debate between manufacturers, pharmacists, FDA and legislators.

 In June 2012, a report released by Republican legislators charged that the FDA was responsible for the shortages after the agency forced several manufacturers to shut down for quality problems at their manufacturing  facilities. FDA officials subsequently fired back at the legislators, saying the problems were largely the fault of manufacturers, whose problems were outside the agency's purview.

Still other legislators-Democratic this time-defended the agency in a July 2012 report, noting that many shortages were caused by so-called "gray market" pharmacies, which bought up drugs in short supply and later sold them at exorbitant prices.

Industry, meanwhile, has largely stayed out of the fray in a direct way, though its trade organizations have tried to make constructive inroads with FDA. In August, the Generic Pharmaceutical Association (GPhA) received Federal Trade Commission (FTC) approval for a drug shortage program aimed at sharing shortage information among companies in the industry, which formerly could not do so under competition rules enforced by FTC.

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