Tom Harkin predicts bipartisan solution in meningitis outbreak
The Democratic chairman of a congressional panel investigating a deadly fungal meningitis outbreak linked to compounded steroids predicted on Thursday that U.S. lawmakers would take actions to prevent a similar public health disaster.
The lawmaker, Sen. Tom Harkin of the Senate Health, Education, Labor and Pensions Committee, predicted that his panel would find a bipartisan solution that would protect small drug compounders from regulations that could mean higher compliance costs.
"In the face of such a tragedy, it is natural to want to take action. And we will," Harkin said at the outset of a hearing to probe the cause of the outbreak linked to Framingham, Mass.-based pharmacy, New England Compounding Center, which has killed 32 people so far.
"What is important to remember, however, is that drug compounding is essential and that most pharmacies that compound do so on a vastly smaller scale than NECC."
Harkin's views were echoed by Senator Pat Roberts, a Kansas Republican, who angrily recounted earlier legislative efforts to tighten oversight of large compounders that were defeated by political opposition reinforced by industry lobbying.
The call for legislative action is also backed by federal and state health regulators.
"If we fail to act, this type of incident will happen again.
The Senate hearing was the second in as many days to examine the events that led to the tragedy and debate the need for new legislation that could provide the U.S. Food and Drug Administration with new powers to oversee the little-known, lightly regulated practice of drug compounding.
A leading trade organization for compounding pharmacies told the committee in written testimony that compounders should remain primarily under state scrutiny.
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.
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.
Calls for stronger FDA authority over drug compounding have been voiced by Democrats in the Senate and Republican-controlled House of Representatives. But Republican leaders have called for a more cautious approach, emphasizing the failure of FDA and Massachusetts state regulators to act against NECC despite repeated problems with its products and business operation.
"We must break down this situation piece by piece to discuss how this tragedy occurred in order to prevent its repeat in the future." The International Academy of Compounding Pharmacists, headquartered in Missouri City, Texas, told the 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.
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 his written testimony.
"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." 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.
Hamburg and Dr. Lauren Smith, interim commissioner of the Massachusetts Department of Public Health, have told 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 says 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.
The FDA chief said the agency will host a meeting on Dec. 19 with state regulators from across the country to discuss a possible framework for new federal authority.