Published November 15, 2012
U.S. states should remain the primary regulators for compounding pharmacies, rather than the U.S. Food and Drug Administration, despite a deadly fungal meningitis outbreak that has killed 32 people since September, an industry group said on Thursday.
The International Academy of Compounding Pharmacists, headquartered in Missouri City, Texas, told a U.S. Senate oversight panel that the meningitis outbreak raging across 19 states occurred because regulatory officials at both the state and federal levels failed to take action under current laws.
The company, Framingham, Massachusetts-based New England Compounding Center (NECC), faces several investigations including a federal criminal probe over unsanitary conditions at its production site and operations that critics say amounted to drug manufacturing that eluded scrutiny by FDA and the Massachusetts Board of Registration in Pharmacy.
"Massachusetts' board obviously failed to execute its responsibilities both to its citizens as well as patients in other states," the industry group's Chief Executive David Miller said in written testimony submitted to the Senate Health, Education, Labor and Pensions Committee.
"The state and the FDA should have worked together to force the pharmacy to register as a manufacturer," he said. "NECC showed blatant disregard for existing rules and regulations."
Miller submitted his testimony ahead of a Senate committee hearing to examine the cause of the meningitis outbreak and determine whether new federal legislation may be necessary to bolster FDA authority over pharmacies that compound drugs in large quantities, especially sterile products.
The outbreak has produced 461 cases of rare fungal meningitis, and more are expected with as many as 14,000 people exposed to methylprednisolone acetate epidural injections that NECC sold in 23 states for treatment of back and joint pain.
The House of Representatives Energy and Commerce Committee held a similar hearing on Wednesday at which Republican lawmakers charged that FDA had the authority to act against NECC but failed to do so in time to avert the public health crisis.
FDA Commissioner Margaret Hamburg and Dr. Lauren Smith, interim commissioner of the Massachusetts Department of Public Health, both told House lawmakers that current laws which leave oversight of compounders to states are inadequate and that new legislation is needed to bolster FDA authority to register and regulate large-scale compounding operations.
Hamburg complained that her agency routinely faces lawsuits and other challenges when they attempt to scrutinize compounding pharmacy operations. Legal action has already produced conflicting federal court rulings about FDA powers in different parts of the country.
But Miller said FDA is already capable of regulating pharmacies that engage in manufacturing or run afoul of state regulators.
"Since the practice of pharmacy is already regulated at the state level, the majority of policy and oversight is best if implemented, addressed, enforced at the licensure level," he said in testimony released by the Senate committee.
"States have the ability to remove a pharmacy's license if that pharmacy is not operating within its licensure requirements," Miller added.
Drug compounding is a little-known practice in which pharmacists traditionally alter or recombine drugs to meet the special needs of specific patients with a doctor's prescription. It is overseen primarily by state authorities that critics say are often ill-equipped for the job.
But in some cases, as with NECC, compounding has evolved to include large-scale production that some experts view as drug manufacturing that should be, but currently is not, subject to FDA regulation.
While Republicans remain skeptical about the need for new legislation, Democrats in the House and Senate have called for bipartisan action before the end of this year.