FDA, States Weigh Pharmacy Regulation in Wake of Meningitis Outbreak
THURSDAY Dec. 20, 2012 -- State public health officials want the U.S. Food and Drug Administration to play a stronger role in regulating large-scale compounding pharmacies to prevent tragedies like the recent nationwide meningitis outbreak, officials said at a meeting in Washington, D.C., on Wednesday.
Health officials from 50 states and FDA representatives met to discuss regulatory concerns after contaminated vials of a steroid medication for back and joint pain sickened 620 people with meningitis in 19 states. Thirty-nine have died. All received injections for back pain made by a Massachusetts-based specialty drug firm called the New England Compounding Center.
Typically, states -- not the FDA -- govern pharmacies, but many states lack the resources to oversee large-scale operations such as the New England Compounding Center (NECC), the state officials said, according to The New York Times.
"The consensus in our group was that there is a role for the FDA to be involved in facilities like NECC," Cody Wiberg, executive director of the Minnesota Board of Pharmacy, told the Times. "If you're talking about compounding, most states have the authority and resources to handle that," he said. Not as many states can effectively oversee manufacturing enterprises such as the New England Compounding Center, he added.
Compounding pharmacies mix or alter ingredients to create drugs to meet specific needs of individual patients, but the business has mushroomed since the 1990s. And FDA Commissioner Dr. Margaret Hamburg told the newspaper that the laws have not kept pace with changes in the industry.
"It is very clear that the health care system has evolved and the role of the compounding pharmacies has really shifted," said Hamburg, who called for greater oversight by the FDA in testimony before Congress last month.
But she and others expressed concern that heavy-handed measures might harm the health care system. The ability to tailor medications to individual patients is important, experts noted.
Some critics have said the FDA has shirked its responsibilities. "There should be one uniform federal standard that is enforced by one agency -- the FDA," Michael Carome, deputy director of the consumer advocacy organization Public Citizen's Health Research Group, told the Times. "They have been lax in enforcing that standard."
The New England Compounding Center ceased operations after the start of the meningitis outbreak early in October.
Compounding pharmacies aren't subject to the same FDA oversight as regular drug manufacturers. Some members of Congress have called for greater FDA regulation of these businesses.
The owner of the New England Compounding Center refused last month to testify before a House of Representatives committee investigating the steroid/meningitis outbreak.
Meningitis is inflammation of the membranes that surround the brain and spinal cord. The steroid injections were used on patients complaining of back or joint pain.
FDA investigators who toured the New England Compounding Center's Framingham plant found foreign, "greenish-black" material in some vials of the injectable steroid suspected as the cause of the illnesses, federal health officials said. The contaminated product was one of a host of potential violations discovered during the recent inspection, the officials said.
The CDC and state health departments estimate that roughly 14,000 patients may have gotten steroid injections from the New England Compounding Center.
The U.S. National Library of Medicine has more about injections for back pain.
Posted: December 2012
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