Meningitis Regulatory Failures

FOIA Reveals Compounding Pharmacies Supplied Thousands of Tainted Vials

Documents that were recently released in response to the Freedom of Information Act revealed that the compounding pharmacy that supplied thousands of tainted vials of methylprednisolone acetate had thwarted or side-stepped Food and Drug Administration attempts to regulate its practices for more than ten years. It was also revealed that the efforts that were made by the agency were ineffective, since regulatory jurisdiction of compounding pharmacies lies with the states, not the federal government.

The documents show that the compounding pharmacy, New England Compounding Center in Massachusetts, would frequently refuse to release documents to the FDA, continue to distribute drugs that were under investigation and often refute the legal authority of the FDA to regulate it. There are examples of the compounding center pharmacists willfully giving inspectors false information and concealing the fact that unapproved drugs were being supplied. After becoming aware that the New England Compounding Center was distributing an unapproved eye surgery dye called trypan blue, the FDA inspectors were told that there was none in stock. However, a supply was later found in the clean room of the facility. The chief pharmacist told the agency that NECC would continue to distribute trypan blue, and the FDA had no legal authority to stop it.

There were warnings of potential health risks from the practices of the New England Compounding Center as far back as 2002, and according to a memo summarizing a meeting held with Massachusetts regulators, there was a “potential for serious public health consequences if N.E.C.C.’s compounding practices, in particular those relating to sterile products, are not improved.”

The FDA, however, often failed to act upon its findings in a timely manner. One inspection didn’t result in a report until nearly two years later, when many of the practices that were cited were no longer in operation.

Because compounding pharmacies were never meant to act as national drug manufacturers, there are no actions or regulations in place to govern them. Compounding pharmacies exist in order to provide physicians with specially mixed medications by request; they are not supposed to manufacture drugs for mass distribution, but that is exactly what many of these companies are doing. In order for a compounding pharmacy to come under the jurisdiction of the federal government, it must be proven that the pharmacy is actually manufacturing drugs, but since these pharmacies are legally able to withhold their own records, proof is very difficult to obtain. Drug manufacturers are heavily regulated by the Food and Drug Administration—they must periodically submit to inspections, provide detailed documentation and only distribute drugs that have been approved. Compounding pharmacies are not bound by any of these regulations.