The Food and Drug Administration is stepping up pressure on firms that make drugs for specific individuals, known as compounding pharmacies, as it seeks greater regulatory authority following a deadly meningitis outbreak traced to one such pharmacy.
On Thursday, the agency posted reports on its web site for 28 of 31 compounding pharmacies it inspected between February and April listing a raft of violations ranging from inappropriate clothing for sterile drug processing to insufficient testing for contaminants.
In two cases the FDA said its inspections were delayed because investigators were forced to obtain search warrants. Several other pharmacies attempted to block access to records. The agency said it is reviewing the information obtained during the inspections and will take enforcement action "as appropriate."
But the agency reiterated its position that it does not have enough authority to always take enforcement action following inspections unless specific violations have taken place, such as the distribution of a contaminated drug -- a claim some Republican lawmakers question.
Compounding pharmacies are supposed to provide individually mixed drugs for specific patients who might not be able to get a product elsewhere or in the right format. Over the past decade some of these firms have burst out of that limited role and now ship large volumes of product to hospitals and doctors across the country, taking on, in the process, some of the characteristics of a traditional, regulated pharmaceutical company.
The release of the inspection reports comes five days before a congressional hearing into the meningitis outbreak traced to the Framingham, Massachusetts-based New England Compounding Center (NECC) that killed more than 50 people and sickened hundreds. The hearing, by the House Committee on Energy and Commerce, will be the second held on the matter.
In November, the FDA's commissioner, Dr. Margaret Hamburg, testified before the same committee that ambiguities in the law had inhibited its ability to take aggressive enforcement action against compounding pharmacies, which are mostly regulated by the states. Republican lawmakers argued that the agency has plenty of authority but failed to use it in a way that could have prevented the meningitis outbreak.
The FDA issued a warning letter to NECC in 2006 following an inspection four years earlier that had revealed problems. Yet it failed to follow up on the warning. Hamburg told the committee in November that NECC repeatedly challenged the agency's authority.
On Thursday a group of Democratic lawmakers urged the Committee in a letter to invite the head of the International Academy of Compounding Pharmacists (IACP), an industry association, to testify at Tuesday's hearing.
"The hearing will focus on why FDA has not acted more forcefully to protect the public from the risks of improperly compounded drugs," the letter said. "Internal IACP documents provided to the Committee reveal that for almost two decades, the organization lobbied aggressively and successfully to restrict FDA authority over compounding pharmacies, even when top IACP leaders were aware of significant public health risks from compounding."
Last month the IACP wrote to members of the Senate Committee on Health, Education, Labor and Pensions in a bid to head off any attempt to allow the FDA to determine whether a firm should be classed as a compounding pharmacy and which pharmaceuticals company. That authority, the letter said, "should and must remain exclusively" with the states.
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