Mary Calvert/Reuters
Margaret Hamburg, the F.D.A. commissioner, testified on the meningitis outbreak before Congress in November. She addressed the need for greater federal oversight of large compounding pharmacies, which mix 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, testified in Congress last month 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 the states see the federal role. Some states said they would prefer to see the F.D.A. handle large-scale compounders like the New England Compounding Center, or N.E.C.C., the Massachusetts pharmacy that was the source of the outbreak.
“The consensus in our group was that there is a role for the F.D.A. to be involved in facilities like N.E.C.C.,” said Cody Wiberg, the executive director of the Minnesota Board of Pharmacy. “If you’re talking about compounding, most states have the authority and resources to handle that. If you’re talking about nontraditional compounding,” he said, referring to large-scale enterprises like N.E.C.C., “fewer states may have the resources to do that.”
Large-scale compounding has expanded drastically 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 had not kept pace.
“We need legislation that reflects the current environment and the known gaps in our state and federal oversight systems,” Dr. Hamburg said.
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, although 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 that 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, like IV feeding tube bags, for example. 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.”
The central problem, state representatives said, is how to define large-scale compounding. Should companies be measured by how much they produce, whether they ship across state lines, the types of products they produce, or some combination of those factors?
“It’s easy to stand at a distance and ask why can’t there be a bright line?” said Jay Campbell, executive director of the North Carolina Board of Pharmacy. “Let’s not let the perfect get in the way of the good. We won’t be able to make a distinction that is razor sharp.”
Large-scale compounders play an important role in the health care supply chain when they produce high-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 that states were not equipped to regulate the large-scale compounders and that the F.D.A. needed 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
