(Reuters) – Democratic and Republican lawmakers said on Thursday they would alter the regulation of drug compounding pharmacies in hopes of preventing more crises like the rare fungal meningitis outbreak that has now cost 32 lives.
The outbreak of 461 cases in 19 states has been linked to tainted steroid injections from a Massachusetts pharmacy and led to public condemnation of the U.S. Food and Drug Administration and state pharmacy regulators for failing to act against known problems over the course of a decade.
A Thursday hearing before the Senate Health, Education, Welfare and Pensions Committee brought the strongest signs so far of bipartisan willingness to approve legislation that could break down the current separation of powers between the FDA and individual state regulators charged with overseeing drug compounding.
“Our first order of business (is) to answer these questions: not just whose job was it to prevent this tragedy, but whose job will it be to make sure it doesn’t happen again,” said Republican Senator Lamar Alexander of Tennessee, the state that has become the outbreak’s epicenter with 83 cases and 13 deaths.
Alexander suggested the FDA could be given powers to certify individual states as the primary regulators of large-scale compounders and withdraw certification from those that fall short.
Senator Pat Roberts, a Kansas Republican long associated with efforts to reform the current regulatory framework, said the outbreak’s repeated loss of life underscores the need for “appropriate measures” to protect patients.
“In the face of such a tragedy, it is natural to want to take action. And we will,” said Senator Tom Harkin, the Iowa Democrat who chairs the Senate committee.
The health disaster behind the debate centers on the Framingham, Massachusetts-based New England Compounding Center, which officials say produced epidural injections for back and joint pain in unsanitary conditions and shipped more than 17,000 tainted doses to customers in 23 states between May and September.
But health officials say the current outbreak is only the latest public health menace that has been linked to large-scale compounding pharmacies, which are exempt from FDA manufacturing standards for safety and efficacy and regulated largely by states that critics say are often ill-equipped for the job.
The senators spoke about measures that could empower the FDA to impose new federal production standards on large-scale compounding pharmacies and certify state pharmacy boards to regulate compounding while retaining the clear authority to step in when necessary.
The appearance of bipartisan support in the Senate stands in contrast with the Republican-led House of Representatives, where Democratic calls for action were met by skepticism among Republicans who argued at a Wednesday hearing that the FDA had the authority it needed to act against NECC but failed to protect the public.
“If we fail to act, this type of incident will happen again. It’s a matter of when, not if, I’m afraid,” FDA Commissioner Margaret Hamburg told the Senate panel.
WHO NEEDS AN FDA?
Lawmakers and regulators have made clear that their target is not pharmacies that engage in traditional drug compounding, a longstanding practice in which pharmacists alter or recombine existing drugs to meet the special needs of specific patients with individual prescriptions.
But in some cases, 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.
Hamburg, who spent four hours facing withering Republican attacks before the House Energy and Commerce Committee on Wednesday, came under fire from senators of both parties for actions not taken against problems identified at NECC during the Bush and Obama administrations.
“Why do we even have an FDA and why do you have a job, if the FDA can’t stop back-alley large-scale drug manufacturing that it knows about?” an exasperated Roberts asked the FDA chief.
Roberts demanded that Hamburg say whether FDA had the authority to act: “You said it was a gray area. I don’t want a gray area. I want a black or white answer!”
“We have authority. But it is limited and unclear and contested,” Hamburg replied.
“Well that’s a hell of an authority,” Roberts concluded.
Democratic Senator Richard Blumenthal, the first lawmaker to call for a criminal investigation of NECC, confronted Hamburg by asserting that having limited authority was no excuse for the agency’s lack of action.
“So is a lot of federal authority and state authority, and it’s used effectively to prevent wrongdoing and law breaking by companies like NECC,” the Connecticut lawmaker said.
Hamburg is calling on lawmakers in Congress to provide new legislation that would leave traditional compounders to state regulators but give FDA clear authority to register and regulate “nontraditional” compounders involved in large-scale operations, interstate commerce or production of sterile drugs.
Officials say the FDA’s authority needs to be clarified in part because of conflicting federal court rulings about whether the FDA can regulate compounded products as “new drugs” under the U.S. Food, Drug and Cosmetic Act.
A leading trade organization for compounding pharmacies told the senators on Thursday that it favors congressional action to address the impact of the court rulings, which prevent FDA action in western states but allow it in the southwest.
“There’s definitely clear confusion about authority,” said David Miller, chief executive of the Missouri City, Texas-based International Academy of Compounding Pharmacists.
In written testimony to the committee, Miller said the industry believes the problem to be companies who use the compounding pharmacies to pursue illegal drug manufacturing and that the FDA already has the authority it needs to stop them.