FDA, States Weigh Pharmacy Regulation in Wake of Meningitis Outbreak12/20/12
THURSDAY, Dec. 20 (HealthDay News) -- 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.
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