FDA Chief Renews Push for Specialty Pharmacy Rules
The head of the Food and Drug Administration renewed her push Wednesday for new laws to help police pharmacies like the one that triggered a deadly meningitis outbreak, even as members of Congress expressed little interest in cooperating with the agency.
FDA Commissioner Margaret Hamburg met with state pharmacy regulators at a meeting to discuss the oversight of compounding pharmacies like the New England Compounding Center, the company which triggered a now 3-month-old outbreak of rare fungal meningitis.
Contaminated injections from the Framingham, Mass.-based company have been blamed for 39 deaths and 620 illnesses, according to the Centers for Disease Control and Prevention. About 370 of the cases were caused by a rare form of fungal meningitis, which causes inflammation on the lining of the brain and spinal cord.
Hamburg said federal and state health inspectors need to work together more closely to oversee compounding pharmacies, which fall into a legal gray area between various state and federal laws.
"We can do the most effective work when we do it in partnership," Hamburg told the heads of 50 state pharmacy boards, gathered at the FDA’s headquarters. "This is a shared responsibility and the states are obviously on the front line of this issue."
Compounding pharmacies, which mix customized medications based on doctors’ prescriptions, have traditionally been overseen by state pharmacy boards, many which date back to the 19th century. The FDA mainly oversees multinational pharmaceutical manufacturing companies like Pfizer Inc. and Merck & Co. In the last two decades, the agency has begun scrutinizing larger compounders like the NECC, which mass-produce thousands of vials of drugs that can be shipped nationwide.
The FDA says new laws are needed to regulate these so-called "nontraditional" compounding pharmacies. Hamburg has proposed a new system under which nontraditional pharmacies would have to register with the FDA and undergo regular inspections, similar to pharmaceutical manufacturers. Small compounding pharmacies would continue to be regulated by state pharmacy boards.
Hamburg told reporters at the meeting she was "guardedly optimistic" that Congress would pass the requested legislation.
But House Republicans on Wednesday signaled little interest in moving ahead on the issue, accusing the agency of dragging its feet in cooperating with their investigation into FDA’s oversight of NECC. At a congressional hearing on the outbreak last month, many Republicans said the FDA had multiple chances to shut down the pharmacy and requested internal agency memos on the matter.
"More than a month later, the FDA still has not produced its internal communications and documents related to NECC," said Rep. Fred Upton, R-Mich., who chairs the House Energy and Commerce Committee. "Without this information, we are unable to identify any possible weaknesses and as a result, the necessary corrections."
An agency spokeswoman said the FDA is working to respond to the committee, and has turned over nearly 4,000 pages of documents to congressional lawmakers.
While the FDA’s proposal has idled in Congress it has also attracted criticism from consumer safety advocates - who typically favor more regulation.