Mary Calvert/Reuters
Margaret Hamburg, the F.D.A. commissioner, testified on the fungal meningitis outbreak before Congress in November. Dr. Hamburg addressed the need for greater federal oversight of large compounding pharmacies, which mix up batches of drugs on their own, often for much lower prices than major manufacturers charge.
SILVER SPRING, Md. – The Food and Drug Administration conferred with public health officials from 50 states on Wednesday about how best to strengthen rules governing compounding pharmacies in the wake of a national meningitis outbreak caused by a tainted pain medication produced by a Massachusetts pharmacy.
It was the first public discussion of what should be done about the practice of compounding, or tailor-making medicine for individual patients, since the F.D.A. commissioner, Dr. Margaret Hamburg, last month testified in Congress about the need for greater federal oversight of large compounding pharmacies. So far, 620 people in 19 states have been sickened in the outbreak, and 39 of them have died.
Pharmacies fall primarily under state law, and the F.D.A. convened the meeting to get specifics from states on gaps in the regulatory net and how they see the federal role. Large-scale compounding has expanded dramatically since the early 1990s, driven by changes in the health care system, including the rise of hospital outsourcing.
“It is very clear that the health care system has evolved and the role of the compounding pharmacies has really shifted,” Dr. Hamburg said in a telephone interview on Tuesday. She said the laws have not kept pace. “We need legislation that reflects the current environment and the known gaps in our state and federal oversight systems.”
Under current law, compounders are not required to give the F.D.A. access to their books, and about half of all the court orders the agency obtained over the past decade were for pharmacy compounders, though compounders are only a small part of the agency’s regulatory responsibilities.
The F.D.A.'s critics argue that the agency already has all the legal authority it needs to police compounders. They say many compounders have been operating as major manufacturers, shipping to states across the country, and that the F.D.A. should be using its jurisdiction over manufacturers to regulate those companies’ activities.
“There should be one uniform federal standard that is enforced by one agency – the F.D.A.,” said Michael Carome, deputy director of Public Citizen’s Health Research Group, a nonprofit consumer organization, who has been a critic of the agency’s approach. “They have been lax in enforcing that standard.”
But Dr. Hamburg contends that the distinction is not so simple. Lumping large compounders in with manufacturers would mean they would have to file new drug applications for every product they make, a costly and time-consuming process that is not always necessary for the products they make, which may include IV feeding tube bags. Dr. Hamburg has proposed creating a new federal oversight category for large-scale compounders, separate from manufacturers.
“What concerns me is the idea that we could assert full authority over some of these facilities as though they were manufacturers, as though there were an on-off, black-white option,” Dr. Hamburg said. “That is a heavy-handed way to regulate a set of activities that can make a huge positive difference in providing necessary health care to people.”
Large-scale compounders play an important role in the health care supply chain when they produce quality products, F.D.A. officials say. They fill gaps during shortages and supply hospitals with products that can be made more safely and cost-effectively in bulk than in individual hospitals. Officials said they wanted to make sure the products made by such suppliers were safe, but were also concerned about disrupting that supply.
Carmen Catizone, head of the National Association of Boards of Pharmacy, said states are not equipped to regulate the large-scale compounders and that the F.D.A. needs to find a middle path for regulating them.
“Either hospitals are not going to like the solution, or the manufacturers aren’t going to like the fact that these guys get a shorter path,” he said. “But something’s got to give.”
F.D.A. and States Meet About Regulation of Drug Compounders
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F.D.A. and States Meet About Regulation of Drug Compounders
