As the Food and Drug Administration aims to assert more authority in regulating drug compounding pharmacies like the one responsible for the deadly nationwide outbreak of fungal meningitis, details have emerged that the agency has previously tried to flex regulatory muscle only to bow to state regulators.
According to a New York Times investigation into the activity at New England Compound Center, 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 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.
The Times reports, “the agency would threaten to bring the full force of its authority down on the company, only to back away, citing a lack of jurisdiction.”
But as the agency is seeking more powers that would enable it to regulate companies like NECC and other compounding labs across the country, further details show that the FDA continually delayed releasing or even formulating reports on inspections the agency sponsored or conducted at the Massachusetts company in the last decade. In one instance, it took the FDA nearly two full years to write a report on inspection findings at NECC. When it eventually informed company officials of the alleged violations, most were out-dated and not applicable to the company’s current practices.
That begs the question: If the FDA were to gain some more regulatory control over compounding labs, would it serve the public’s health interests any more than the current arrangement? Now, state regulatory agencies police these compounding labs. In the wake of the imbroglio at NECC, several officials at Massachusetts’ Board of Pharmacy have resigned their positions and interest in how these companies are regulated have been widely debated.
In all, at least 32 people have died and more than 400 have fallen seriously ill after contracting fungal meningitis from a contaminated epidural steroid injection drug mixed and shipped from NECC earlier this year. NECC has recalled all shipments of its drugs since earlier this year and has shut its doors, at least temporarily, as it endures the current public relations and future legal nightmares.
Investigations launched since the outbreak grabbed national attention have revealed that conditions inside NECC were far from any industry standards and not up to state or federal codes for such facilities. Drug compounding labs like NECC mix already-approved pharmaceutical products for new purposes. In the last 10 years, the demand for products from these compounding labs has increased and they now supply much of the specialized drug supplies for several major hospitals.
NECC mixed at least 14,000 vials of methylprednisone acetate and shipped it 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. Only recently were thousands of recipients of these injections, prior to their recall, relieved to hear that the dormancy period for fungal meningitis had passed and the risk of being infected had lessened considerably.