WASHINGTON — Legislation to close the regulatory gaps that led to last year’s deadly outbreak of fungal meningitis in Tennessee and 19 other states appears “pretty close” to being ready, key senators said Thursday.
But members of the Senate Health Education Labor and Pensions Committee also warned that lobbying efforts to oppose the bill are forming, just as they did in 2007, the last time Congress attempted to address oversight of compounding pharmacies.
“The same forces that sunk (that legislation) are out there again,” said Sen. Tom Harkin, D-Iowa, committee chairman.
Harkin and Sen. Lamar Alexander of Tennessee, the ranking Republican on the panel, oversaw a hearing on legislation relating to compounding pharmacies that is due to be marked up or formalized by Memorial Day.
“I think we are pretty close to what we need to do,” Harkin said.
Alexander, when asked if he viewed the bill as adequate, said, “I do.” He said his goal continues to be that the Food and Drug Administration have unambiguous authority over large-scale drug compounders that ship products across state lines.
The proposed legislation that he and other committee members have been working on would make clear that such “compounding manufacturers” are to be federally regulated. The proposal also distinguishes them from traditional drug manufacturers, already regulated by the FDA, and from traditional pharmacies that compound non-sterile drugs in response to prescriptions aimed at a single patient. The FDA has traditionally left such oversight to the states.
“It tries to set clear lines on who is in charge and when they are in charge,” Alexander said. “Clarity is what I am looking for.”
A 1997 law intended to clarify FDA authority over large-scale compounders was mitigated by a series of subsequent federal court decisions.
FDA has concerns
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, told the committee the agency welcomes the proposed legislation but has some concerns, including that it might “blur the line” between traditional manufacturers and large-scale compounders. She also said the agency wants more clearly stated authority to access records of compounders.
But FDA’s request to maintain some state role in dealing with large-scale compounders bewildered Alexander.
“Wouldn’t that just leave us where we are, which is confusion?” Alexander asked Woodcock.
Woodcock said the proposal stems from states’ longstanding role in licensing pharmacists but that the FDA would still assume “full responsibility” for overseeing operations such as the New England Compounding Center in Framingham, Mass.
Woodcock said the FDA views the draft legislation as “a huge step in the right direction.”
It was tainted steroid drugs from NECC that caused the 2012 outbreak of fungal meningitis.
Contact Paul C. Barton
at pbarton@gannett.com.
at pbarton@gannett.com.
quoted from source found here