By THOMAS M. BURTON
The Food and Drug Administration under President Barack Obama didn't push for a law to regulate drug-mixing pharmacies before a recent outbreak of more than 600 meningitis cases tied to such a pharmacy, the head of the agency said Wednesday.
FDA Commissioner Margaret A. Hamburg said her agency didn't press for such a law despite numerous deaths and illnesses over several years linked to compounding pharmacies. She made the remark at a summit meeting the FDA held Wednesday with officials of all 50 states who regulate compounding pharmacies.
During the later years of the George W. Bush administration, FDA officials said, disagreements between senior agency officials led to relative inaction about compounding pharmacies by the agency. In 2007, staffers in the office of Sen. Edward M. Kennedy (D., Mass.) worked with some Republican senators in an effort to further legislation to strengthen FDA supervision over compounders. But a lobbying push by compounding pharmacists' trade association stopped that effort.
Dr. Hamburg has said current law is murky about the authority of the FDA and states, and recently has called on Congress to pass a law to clarify it.
The recent outbreak, including 39 deaths, was linked to injections of the steroid methyprednisolone acetate from New England Compounding Center of Framingham, Mass.
"With respect to this administration, there has not been any formal effort" to clarify the law prior the current illnesses, which began occurring more than two months ago, the commissioner said. Now, she said, "We strongly believe we need additional legislation."
She mentioned cases of deaths in 2005 linked to a Maryland pharmacy's cardioplegia drug used during heart surgery.
There were also adverse events involving a Mississippi pharmacy's anesthesia drug in 2007, and eye inflammation and blindness in 2009 linked to a compounding pharmacy, she said.
State regulators at the FDA meeting in Silver Spring, Md., said several states lack staffing and authority to adequately supervise compounders.
Some court decisions conflict as to what the FDA's authority is, and FDA officials have said that is a big reason why they haven't done more.
"We don't know what's happening at pharmacies that ship into our state," said John Kirtley, executive director of the Arkansas Board of Pharmacy.
The FDA in 2008 sent a letter to NECC declaring the agency's intention to inspect the compounder. But FDA officials acknowledge they never did so until recent weeks, following the multistate cases of a rare and lethal fungal meningitis.
"We are struggling with not knowing how many of these pharmacies are out there," Dr. Hamburg said during a panel discussion.
Cody Wiberg, director of the Minnesota pharmacy board, said "some states don't always have the resources they need" to regulate compounding pharmacies.
Write to Thomas M. Burton at tom.burton@wsj.com
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