The Food and Drug Administration said its authority over compounding pharmacies is limited and needs to be strengthened in the wake of a multistate meningitis outbreak caused by tainted steroid injections produced by a pharmacy in Massachusetts.
The FDA has come under scrutiny
for its oversight of the New England Compounding Center, the Framingham, Mass.-based compounding pharmacy that is responsible for distributing contaminated vials of preservative-free methylprednisolone acetate.
As of Nov. 9, the outbreak has led to 32 deaths, 10 peripheral joint infections, and 428 cases of fungal meningitis and other central nervous system-related infections, according to the Centers for Disease Control and Prevention
In an e-mailed statement, the FDA said the agency and the state of Massachusetts agreed that NECC was operating as a compounding pharmacy after both entities inspected the compounder in 2002 and 2003.
Current laws dictate that the FDA has oversight for drug manufacturing, while state boards of pharmacy are responsible for overseeing compounding pharmacies. Compounders are expected to produce medications for a specific patient.
“FDA's authority over compounding pharmacies is more limited by law and needs to be strengthened,” an FDA spokeswoman said in the statement. “We look forward to working with Congress to prevent this from happening again.”
The House Committee on Energy and Commerce Subcommittee on Oversight and Investigations and the Senate Committee on Health, Education, Labor, and Pensions are expected to hold separate hearings this week about the meningitis outbreak. FDA officials are expected to testify at both hearings.
Barry Cadden, NECC's president, co-owner and managing pharmacist, was subpoenaed by House Committee Chairman Fred Upton (R-Mich.) and Rep. Henry Waxman (D-Calif.), the committee's ranking member, to appear at Wednesday's hearing.
A number of lawmakers have called for legislation that would increase oversight of compounding pharmacies.
NECC and Ameridose, a Westborough, Mass.-based provider of sterile admixing and repackaging services that shares ownership with NECC, have both shut down their operations. In addition, both companies have recalled all products distributed in 2012.