Deborah M. Autor, deputy Food and Drug Administration commissioner for global operations and policy, said it was “really unfortunate that it sometimes takes a tragedy” to bring about change and called on industry officials and lawmakers to adopt a new “regulatory scheme that appropriately controls the risk.” She also said the company could face criminal prosecution.
The officials were responding to questions about why state and federal authorities didn’t move more aggressively against New England Compounding Center in Framingham, Mass., after the FDA found problems during an inspection in 2006. Massachusetts Attorney General Martha Coakley announced an investigation of the NECC after state health officials said the company appeared to violate state licensing requirements.
Fourteen people have died and 170 have been infected from batches of steroid injections contaminated with fungus that were made by the NECC. About 14,000 people received the injections, though it’s not clear how many of those shots were tainted, Centers for Disease Control and Prevention officials said. Some lawmakers already are calling for a criminal probe and new authority for the FDA as a result of the outbreak.
The CDC officials also reported the first infection in a joint — an ankle — that may have been caused by the tainted medicine. More cases of both types of infection are expected.
Fungus causing human disease is notoriously slow to grow and hard to identify. Thirteen cases have been caused by a fungus of the genus Exserohilum and one by the genus Aspergillus. Fungus has been detected in about 50 vials from the company and from clinics that got the product.
J. Todd Weber, the CDC physician leading the investigation of the outbreak, said these are the first meningitis cases caused by Exserohilum ever reported.
The infections have occurred in 11 of the 23 states that got potentially contaminated methylprednisolone acetate from NECC. The medicine is a high-potency, long-acting steroid used to suppress inflammation and relieve pain in people with herniated disks and certain types of arthritis.
The CDC recommendations for treatment of the fungal infection call for two drugs that have to be given intravenously for months. Weber said the drugs are “very strong and can be very difficult for patients to tolerate.”
In 1997, legislation was enacted spelling out the roles of the state and federal governments in regulating compounding pharmacies. But the federal role faced court challenges. As a result, it’s “a murky area,” former FDA commissioner David A. Kessler said.