WASHINGTON -- The FDA has formed a new advisory committee to deal with issues related to compounded medications.
Problems with individually compounded prescriptions attracted national attention in 2012 after tainted preservative-free methylprednisolone acetate for injection, made by the New England Compounding Center (NECC) of Framingham, Mass., was tied to dozens of deaths from meningitis nationwide. The government put the final death toll at 64.
NECC had shipped the medication to pain clinics in 23 states. More than 14,000 patients were exposed to the potentially contaminated spinal injections. On Wednesday, a U.S. attorney in Boston with racketeering and murder in relation to the tainted medications, and 12 other employees are facing lesser charges.
In the wake of that tragedy, in November 2013 Congress passed the Drug Quality and Security Act; it created an optional FDA certification for "outsourcing facilities" -- large-scale compounders like NECC that ship products to multiple states. The law also created a national "track-and-trace" system that requires manufacturers, suppliers, and pharmacies to scan drug packages as they change hands to ensure a dispensed drug's authenticity.
The 14 committee members come from a variety of disciplines, including pharmaceutical compounding and manufacturing, pharmacy, medicine, and pharmaceutical regulation. More than 100 people were nominated to be on the committee after FDA solicited nominations for members.
Some members of the include:
- , director of Public Citizen's Health Research Group
- , executive vice-president of the Institute for Safe Medication Practices
- , associate professor in the school of pharmacy at Virginia Commonwealth University
- , director of drug safety and innovation at The Pew Charitable Trusts
- , professor in the department of anesthesiology and perioperative care at the University of California Irvine
- , chief of the Clinical Center pharmacy department at the National Institutes of Health
"Advisory committees are a very important source of knowledge and advice for drug regulation," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, announcing the committee's formation. "This is a key step toward implementing the compounding provisions of the Drug Quality and Security Act, and I expect we will benefit greatly from the advice and recommendations the members of the committee provide."