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VOL. 37 | NO. 15 | Friday, April 12, 2013




Compounding pharmacies turn away FDA inspectors

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NASHVILLE (AP) - Compounding pharmacies like the one responsible for the deadly outbreak of fungal meningitis last year have refused access to inspectors.

U.S. Food and Drug Administration Commissioner Margaret Hamburg told The Tennessean (http://tnne.ws/12SNi6s) that the FDA had to get court orders to enter and inspect two pharmacies.

"It is striking and very concerning that even in the follow-up to all that has happened with the meningitis outbreak ... we are still having problems getting into some of the facilities in order to inspect them," Hamburg said.

Injectable steroid medicine made by the New England Compounding Center in Massachusetts was responsible for an outbreak that has sickened 733 people across the nation with 53 deaths. The medicine was supposed to be sterile, but it was found to be contaminated with mold.

The outbreak was first identified in Tennessee, where 152 people were sickened with 14 deaths.

Since the outbreak, the FDA has stepped up inspections of compounding pharmacies, which sometimes operate like drug manufacturers but with less regulation.

Howard Sklamberg, the head of compliance for the FDA's center for drug evaluation and research, said the two pharmacies that have refused access to inspectors are Wedgewood Village Pharmacy Inc. in New Jersey and Olympia Compounding Pharmacy in Florida.

"You have to get a judge's order. You have to then get the marshals to accompany our investigators to an inspection, which is not the normal way we do business," Sklamberg said.

Medicine from Wedgewood, which holds a license to ship drugs into Tennessee, was suspected of infecting people, and a veterinary compound it produced may have killed a horse, the FDA said. Several sterility problems were documented during inspections.

Inspectors also found multiple sterilization issues at Olympia, which is not listed as a licensed pharmacy in Tennessee.

Hamburg spoke with The Tennessean ahead of a scheduled Tuesday appearance before an investigations subcommittee of the U.S. House of Representatives Committee on Energy and Commerce.

Committee members scoffed at her in November when she argued for law changes to give her agency greater authority to regulate compounding pharmacies.

Hamburg said she expects a Senate committee to come forward with a legislative proposal "in the very near future." She said U.S. Sen. Lamar Alexander, R-Tenn., the ranking Republican on a key Senate committee, has been a "very constructive influence" during the process.

Alexander's office said legislation should be ready by Memorial Day.

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