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. These "priority inspections" 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 the existing standards and oversight are adequate.
An FDA spokesman said that the investigation of the Florida pharmacy, Axium Healthcare Pharmacy of Lake Mary, Fla., is continuing and that officials do not know what the black particles are. Officials at the company did not return phone 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 in an interview. "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 by FDA officials came ahead of a House Energy and Commerce subcommittee hearing scheduled 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 on the panel want industry officials to testify about their lobbying efforts over nearly two decades to limit FDA authority over compounding pharmacies.
The priority inspections included three companies identified in a Washington Post investigation in February about manufacturing-style compounding pharmacies.
The Post found that shoddy practices and unsanitary conditions at three large compounding pharmacies have been tied to deaths and illnesses over the past decade. The findings showed that serious safety lapses at NECC were not an isolated occurrence.
At Olympia Pharmacy in Orlando, the FDA's inspection was delayed because the investigators had to obtain an administrative warrant to gain access to and make copies of some of the firm's records, FDA officials said.
Scott Livingston, an attorney for Olympia, said the company allowed inspectors access to "everything" during the first two days of the inspection. But "we did question their right to make copies" of certain documents because of patient privacy, he said. After the FDA obtained its warrant, he said, "We immediately provided them with those copies."
Investigators observed several problems with sterile practices, including a technician with a ripped glove, "infrequent sanitizing of gloves" and unsterile clothing worn by technicians, according to the inspection report. Livingston said Olympia is addressing all of the FDA's concerns. Even before the inspection was completed, the company had begun a double-gloving policy, replaced its "clean room" and bought new sterilization equipment, he said.
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 of the inspections.
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 of both types of inspections, several firms have voluntarily recalled their products and others have temporarily suspended making drugs that are supposed to be sterile while they correct deficiencies found by investigators, Hamburg said in a blog post Thursday.
A New Jersey-based company recalled 83 of its products last month after a nurse at Yale-New Haven Hospital in Connecticut found floating particles in bags of medication later confirmed by FDA investigators to be mold. Days later, a Georgia-based company issued a voluntary recall of more than 60 of its products after patients reported eye infections after using Avastin, a drug used by people with macular degeneration.
Since the outbreak, health-care groups and consumer advocates have called for greater oversight of the manufacturing-style pharmacies that dominate the compounding industry. These companies often operate more like drug manufacturers than traditional pharmacies - selling across state lines, often without prescriptions for individual patients - but do not have to pass the rigorous tests for safety and effectiveness required for FDA-approved drugs.
Some members of Congress have sought to beef up the agency's authority, but the industry has successfully killed those efforts. The Senate Health, Education, Labor and Pensions Committee is working on legislation to strengthen the FDA's authority over manufacturing-style compounders.
Because of the regulatory ambiguity, FDA officials said their recent targeted inspections were complicated and time consuming.
When inspectors scrutinize drug manufacturers, they know ahead of time what the companies make and "the rule book you're applying," said Howard Sklamberg, director of compliance for the FDA's Center for Drug Evaluation and Research.
By contrast, inspectors going into the compounding facilities "were learning what the firm is producing while they were actually inspecting," he said.
Hamburg said the priority inspections were not a model that she wants to continue or expand because of limited resources.
The FDA wants the manufacturing-style compounders to register with the FDA and provide basic information about what they make so the agency can inspect them regularly against a uniform standard.
In other developments, the Department of Health and Human Services' inspector general's office released a report Thursday that found that 56 percent of 298 acute-care hospitals surveyed have changed or plan to change their reliance on compounding firms for sterile drugs that are either injected or infused into patients.
Those changes - prompted by the meningitis outbreak - include hospitals upgrading their pharmacies so they can make more of the drugs themselves, although they said the cost and space limitations were "major challenges," the report said.
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