Criticized by members of Congress and patient safety organizations for not doing enough to prevent the fungal meningitis outbreak, the U.S. Food and Drug Administration stepped up inspections of compounding pharmacies only to be refused access.
The FDA had to get court orders to enter two pharmacies, said FDA Commissioner Margaret Hamburg. A total of four initially refused to let inspectors look at their records or watch drug production.
“It is striking and very concerning that even in the followup to all that has happened with the meningitis outbreak and the spotlight that has been on compounding pharmacies and potential health risks that we are still having problems getting into some of the facilities in order to inspect them,” Hamburg said.
She talked to The Tennessean in advance of a scheduled appearance on Tuesday before the same U.S. House of Representatives committee whose members scoffed at her in November when she tried to make the case 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” and hopes the second hearing before the House committee “will be an opportunity to deepen some of the discussions.”
In her last go-around with an investigations subcommittee of the House Committee on Energy and Commerce, members frequently cut her off mid-sentence when she did not directly answer questions quickly enough. The committee also said the FDA failed to provide all the documents it requested.
Steroid medicine made by New England Compounding Center and injected into patients’ spines and large joints as a pain treatment led to the outbreak that has sickened 733 people across the nation with 53 deaths.
“The evidence so far demonstrates NECC should have been shut down long before people tragically lost their lives from contaminated injections,” U.S. Rep. Tim Murphy, R-Penn., chairman of the investigations subcommittee, said in a press release. “With many more still sick, we will continue investigating the breakdown at the FDA so a public health disaster like this one never happens again.”
Hamburg told The Tennessean her agency is committed to working closely with Congress to identify gaps in legislation and noted that U.S. Sen. Lamar Alexander, R-Tenn., the ranking Republican on a key Senate committee, had been a “very constructive influence.”
Hamburg said the recent challenges to the FDA’s right to conduct inspections illustrate why law changes are needed. Howard Sklamberg, the head of compliance for the agency’s center for drug evaluation and research, identified the two pharmacies that refused access to inspectors as Wedgewood Village Pharmacy Inc. in New Jersey and Olympia Compounding Pharmacy in Florida.
“If you start doing an inspection and the pharmacy refuses you access to records or to part of the facility, you have to interrupt the inspection,” Sklamberg said. “You have to prepare a legal document. It has to go to the Justice Department. 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. When we inspect typical drug firms, we walk in and they know what our authority is.”
The inspection at Wedgewood was “for cause” when the agency had reason to believe there were issues, while the Olympia inspection was a “surveillance” inspection.
Medicine from Wedgewood 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 at Wedgewood from November through February. One pharmacy technician failed to sanitize hands before going to the mixing area. The gowning of employees failed to adequately cover the neck area and shoes. Other employees had exposed hair and wore jewelry, including large hoop earrings. Another employee wore headphones, allowing the cord and earpieces to touch the working area of the pharmacy.
Inspectors also found that compounds were not always tested for sterility and there were lapses in recordkeeping to track the sterility of components used to mix drugs.
Olympia was one of about 31 compounding pharmacies targeted for “surveillance” inspections between February and April of this year as determined by a risk-based model. The FDA had to get a court order and be accompanied by U.S. marshals to collect the company’s records and complete the inspection.
“We did recently undertake a series of what we call surveillance inspections, where we identified a set of compounding facilities that we had reason to believe were making higher-risk products, specifically the sterile injectables,” Hamburg said. “We developed an inspection protocol. We went in more or less unannounced to do inspections so that we could really better understand the nature and the scope of the problem and get a better idea of what kinds of facilities that are out there and the products they are making and the kinds of procedures they are following and if there were concerns.”
Inspectors found multiple sterilization issues at Olympia, which is owned by Lowlite Investments Inc. The pharmacy failed to do proper microbial air monitoring or adequately check areas where medicine was mixed for contaminants, the inspection found.
There were also issues with the protective gowns employees wore.
“Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform,” the inspection report stated. “Specifically, the gown, booties, hairnet and facemask worn in the clean room are not sterile. The knee-length gown only ties at the neck and waist and does not fully cover street clothes. In addition, gowning does not provide complete coverage of the skin on the face and neck.”
And the report found that Olympia failed to adequately sample drugs for sterility or quality.
“Endotoxin testing has never been performed on finished injectable drug products,” the report stated.
Contact Tom Wilemon at twilemon@tennessean.com or 615-726-5961.
Source found here
No comments:
Post a Comment