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FDA finds new safety problems at 30 specialized pharmacies

  • Article by: Lena H. Sun
  • Washington Post
  • April 11, 2013 - 10:16 PM

Federal inspectors have found dozens of potentially dangerous safety problems at 30 specialized pharmacies, months after tainted steroid shots made by a Massachusetts pharmacy triggered the worst drug disaster in decades.

At a Florida company, Food and Drug Administration inspectors discovered “black particles of unknown origin” in seven vials of an injectable medicine. At other facilities, they found rust and mold in “clean rooms,” inadequate microbial testing and tears in gloves worn by technicians — lapses that raise the risk of possible lethal contamination.

The inspections, conducted between February and April, marked the first time that the FDA targeted specialized pharmacies, known as compounding pharmacies, since inspectors found filthy conditions at the New England Compounding Center (NECC), the Massachusetts pharmacy at the heart of the fungal meningitis outbreak that killed 53 people and sickened 680 others, including at least 13 Minnesotans who were treated with steroids.

The outbreak led to notifications being sent to more than 800 Minnesotans treated at two Twin Cities clinics that they might have received potentially contaminated steroids that were produced at NECC. Medical Advanced Pain Specialists (MAPS) and the Minnesota Surgery Center were the only clinics in Minnesota that were known to have used the compounding company’s steroids.

As a result, these “priority inspections” by the FDA were focused on firms that produce high-risk sterile products, a key segment of the multibillion-dollar industry that has fallen between the regulatory cracks.

FDA officials say the inspections show compounders, in many cases, are failing to ensure the safety of their products, despite months of stepped-up scrutiny from state and federal regulators, as well as consumer groups. They say Congress should give the agency more authority over compounders of high-risk sterile products; these companies do not have to meet the same standards as drug manufacturers, even though some mass-produce medications. Industry officials counter that existing oversight is adequate.

‘Serious risk to health’

An FDA spokesman said that the probe of the Florida pharmacy, Axium Healthcare Pharmacy of Lake Mary, Fla., is continuing and that officials do not know what the black particles are. Company officials did not return calls seeking comment.

Five of the pharmacies inspected by the FDA initially denied investigators access to their facilities or to their records, or refused to let them make copies of records. The agency prevailed — but in one case not until after it had a court-ordered inspection warrant.

“This shows us that there are facilities out there that are producing products that have significant sterility failures, ones that could represent a serious risk to health,” FDA Commissioner Margaret Hamburg said. “Sadly, it also demonstrates, even in light of this tragedy and all of the focus on the issue, that we are still being challenged in our attempt to enter these facilities.”

The comments came ahead of a House Energy and Commerce subcommittee hearing set for Tuesday in which Republican members are expected to ask why the agency didn’t take more forceful action against NECC before the outbreak. Democrats want industry officials to testify about their lobbying efforts over nearly two decades to limit FDA authority over compounding pharmacies.

Gaps in the law

The FDA is evaluating information obtained during the inspections. It plans to “take aggressive action” against those companies that are going beyond the traditional bounds of pharmacy compounding, which entails the custom-mixing of medications for individual prescriptions, according to an FDA summary. But in some cases, gaps in the law and conflicting court rulings limit the FDA’s authority, requiring the agency to coordinate with state authorities. States issue the licenses to pharmacies and are their primary regulator, but enforcement among states is uneven.

In addition to the priority inspections, the FDA has inspected about a dozen other compounding pharmacies in response to complaints about drugs or requests from state authorities, FDA officials said. As a result, several firms have voluntarily recalled their products and others have temporarily suspended making drugs that are supposed to be sterile while they correct deficiencies, Hamburg said.

Staff writer M.L. Smith contributed to this report.

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