WASHINGTON — The commissioner of the federal Food and Drug Administration will recommend changes in the regulatory landscape for compounding pharmacies, placing those that produce drugs on a large scale in a new category that would give the agency greater powers to police them.
The commissioner, Dr. Margaret Hamburg, will tell the House Committee on Energy and Commerce during a hearing on Wednesday that compounding in its traditional form — mixing medicine for individual patients — should be preserved, but that pharmacies that have in effect turned into mini-drug companies should be placed under the agency’s oversight, according to her written testimony posted by the committee.
Pharmacy compounding has come under a spotlight in recent months since the New England Compounding Center in Framingham, Mass., produced thousands of vials of pain medicine contaminated with fungus that caused a national meningitis outbreak, sickening more than 400 people and killing 32. Dr. Hamburg’s testimony was her first substantive comment on regulatory problems in the compounding industry since the outbreak, and outlines the changes that the Obama administration will seek.
Among the changes proposed by Dr. Hamburg are requiring larger compounders to register with the F.D.A. and abide by its so-called good manufacturing practice, which requires drug producers to report any problems with their products to the agency. She is also recommending new labeling requirements that would make the origin and the risks of a compounded drug clear. She is also requesting that some products, including drugs with complex dosage forms, be banned for compounders.
“In light of growing evidence of threats to the public health, the administration urges Congress to strengthen federal standards for nontraditional compounding,” Dr. Hamburg stated in the written testimony. “Such legislation should appropriately balance legitimate compounding that meets a genuine medical need with the reality that compounded drugs pose greater risks than those that are evaluated by F.D.A.”
Large-scale pharmacy compounding has greatly expanded since the early 1990s, lifted by tectonic shifts in the health care industry, including a widespread turn toward outsourcing. The practice fills shortage gaps in the health care system and provides lower-cost drugs. But pharmacies are primarily regulated by states, a situation that federal regulators argue is risky.
The F.D.A. had dealings with the New England Compounding Center in the past, including an inspection in 2002 after reports of problems and a warning letter in 2006. The agency argued that the actions failed to head off the current disaster, in part, because the company took great pains to avoid F.D.A. oversight.
“Throughout this time, N.E.C.C. has repeatedly disputed F.D.A.’s jurisdiction over its facility,” Dr. Hamburg said in the written testimony.
Barry J. Cadden, the chief pharmacist at the company and one of its principal owners, was subpoenaed by the House committee. To every question posed by committee members on Wednesday, he replied: “On advice of counsel, I respectfully decline to answer on the basis of my constitutional rights and privileges, including the Fifth Amendment to the U.S. Constitution.”
F.D.A. Asking for More Control Over Drug Compounding
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F.D.A. Asking for More Control Over Drug Compounding
