WASHINGTON — Legislation to increase federal oversight of large-scale drug compounders — like the New England firm linked last year to 16 fungal meningitis deaths in Tennessee — passed the Senate Monday, clearing the way for President Barack Obama to sign it into law.
Critics, however, contend it falls short in protecting public health.
The measure, passed unanimously on voice vote, is intended to address the regulatory gaps between the federal Food and Drug Administration and state pharmacy boards when it comes to large-scale compounders who ship their products in interstate commerce.
"Just because it was unanimous, I don't want anyone to think it was easy. Just because it was unanimous, I don't want anyone to think it was unimportant," Republican Sen. Lamar Alexander of Tennessee said in a floor speech.
Alexander, as a member of the Senate Health, Education, Labor and Pensions Committee, played a major role in drafting and passing the legislation. Congressional hearings started a year ago this month. In September, the bill cleared the House by voice vote also.
A legal gray area between federal and state regulators was blamed in 2012 for allowing the New England Compounding Center in Framingham, Mass., to send out contaminated steroid drugs nationwide.
The shipments resulted in illness for 751 patients nationwide, including 64 deaths. Tennessee, with 153 cases and 16 deaths, was second only to Michigan, which had 264 cases and 19 deaths.
Traditional compounding — pharmacists at local drug stores creating customized medicines in response to individual prescriptions — has long been under state regulation, while the FDA concentrated on overseeing manufactured drugs.
But authority over large-scale compounders like NECC was blurred by various federal court decisions over the past 15 years, FDA officials said.
Supporters of the new bill say it will give the FDA clear authority to shut down firms like NECC.
But critics, including watchdog groups like Public Citizen, contend that authority would apply only after contaminated drugs reach the marketplace.
The bill makes it optional for large-scale compounders to register with the FDA as an "outsourcing facility," which would subject them to regular inspections and higher quality standards before they ship drugs. States would have authority over those that don't register with the federal agency.
Even firms that choose to register will be subject to less stringent requirements than traditional drug manufacturers, critics say.
"This ultimately undermines requirements that have been in place for more than 50 years," said Michael Carome of Public Citizen. "This (creates) a substandard group of manufacturers that have to follow some of the rules but not all of them."
A prominent lobbying group, the International Academy of Compounding Pharmacists, remained critical as well.
"If the goal of this legislation is to prevent another NECC, which has been stated many times over, then the American public must know that this bill will not accomplish that goal. A voluntary category of outsourcing facilities is not the answer," the group said in a statement.
"Would NECC, with its alleged myriad violations of law and regulations, have voluntarily enrolled in this new category? We think the answer is clear."
Alexander, in an interview after the vote, said he would have preferred the original Senate version, which would have required all NECC-type firms to register with the FDA.
Still, the senator said, pressure from hospitals and doctors will likely encourage many such firms to submit to FDA regulation.
Two Tennessee compounders, Pharmedium and CAPS (Central Admixture Pharmaceutical Services), have announced they will register with the FDA.
"Some large compounders will say it's better to say, 'We are an FDA-regulated facility,'" the Tennessee senator said.
Alexander added that the bill ranks "very high" among his legislative accomplishments in 12 years as a senator, because each of the 153 cases in Tennessee was "very personal and very tragic."