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.