Consumer Group to FDA: Re-Inspect Compounding Pharmacies with Prior Violations

The U.S. Food & Drug Administration (FDA) is being urged to re-inspect a number of compounding pharmacies that had been previously cited with violations. Public Citizen, a consumer watchdog group is asking the agency to re-inspect 16 compounding pharmacies in 15 states that were issued prior warnings for safety lapses by the FDA since 2003, said The Salt Lake Tribune. The group points out that, in light of the ongoing fungal meningitis outbreak that has sickened over 500 people and led to 36 deaths, a new look at the pharmacys are in order.

The warnings “reveal a thriving [drug making] industry … being carried out under the guise of compounding,” the group wrote to FDA Commissioner Margaret Hamburg.

The New England Compounding Center (NECC), the pharmacy blamed for the outbreak, mixed at least 14,000 vials of methylprednisone acetate and shipped the drugs to more than 70 pain management and other health care clinics in 23 states. Testing on sample vials showed that many of them were contaminated with a fungus responsible for the outbreak of the deadly form of meningitis.

The outbreak appears to have begun in late September when physicians in Tennessee were treating a man with an unusual form of meningitis that did not appear to have a bacterial or viral cause. Evidence of fungal infection was detected and involved the mold, Aspergillus fumigatus. The physicians advised the state’s public health authorities and, soon, injections of a steroid, methylprednisolone acetate, were linked to this first case and to other, subsequent cases. The tainted steroid was injected into patients’ spines or joints for chronic back pain.

NECC was later discovered to be tainted with a fungus that was not Aspergillus; a black mold, Exserohilum rostratum, is believed to be the culprit in the outbreak. That mold is one of several organisms that only rarely cause human disease and has been discovered in some vials containing the steroid and in several of those who were sickened; however, the fungus has been challenging to isolate in many of the patients, according to a prior MedPage Today report.

As we’ve said, according to a New York Times investigation into NECC, documents released after the newspaper’s Freedom of Information Act request show that the FDA has continuously backed away from asserting any power against the company because it states it feared a legal struggle as it does not hold the same power over these companies as state regulators.

The FDA has known since at least 2002 about possible manufacturing and procedural problems at NECC. And, further details show that the FDA continually delayed releasing or even formulating reports on inspections the agency sponsored or conducted at the NECC in the last decade. In one case, it took the FDA nearly two years to write a report on inspection findings at NECC. When it finally informed company officials of the alleged violations, most were out-dated and not applicable to the company’s current practices.

The NECC had been investigated three times by the agency and was issued a warning in 2006, according to a Congressional investigation, said the Salt Lake Tribune.

Compounding pharmacies are meant to manufacturer small batches of commercially approved drugs, customized for physicians to meet specific patient needs, the Salt Lake Tribune explained. More and more, it seems, these pharmacy have expanded to larger operations that fall under the radar of typical pharmaceutical regulation.

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