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Hospital Pharmacists Want Better Oversight of Drug Compounders

November 15, 2012

Hospital pharmacists are backing a call by the Food and Drug Administration for added regulation of compounding companies after a meningitis outbreak, calling it a “gray area” with serious implications.

FDA Commissioner Margaret Hamburg’s request for greater federal power to inspect compounding companies and test their medicines yesterday drew skepticism from House Republicans during a subcommittee hearing yesterday on the outbreak, which has infected 438 people and killed 32. The statement by the hospital pharmacists came in prepared remarks for a probe by the Democratic-controlled U.S. Senate.

“The distinction between traditional pharmacy compounding and manufacturing appears to be a regulatory gray area between state boards of pharmacy and FDA,” Kasey Thompson, vice president of policy for the American Society of Health-System Pharmacists, said in prepared testimony. “As we have seen, however, the implications of this gray area are serious.”

Both houses of Congress are weighing whether to expand the FDA’s powers over compounders after tainted vials of a pain- killing steroid from New England Compounding Pharmacy Inc. were linked to the meningitis infections. Yesterday’s hearing in the House was contentious for Hamburg; she’ll face similar questions in the Senate panel hearing today.

House lawmakers were skeptical yesterday when Hamburg asked for additional authority. The International Academy of Compounding Pharmacists, the industry’s main lobbying group, will tell the Senate panel today that no oversight change was needed, according to prepared remarks.

‘Same Laws’

“A pharmacy engaged in manufacturing is subject to the same laws, inspections, restrictions, and penalties as a commercial drug manufacturer,” David Miller, the group’s chief executive officer, said in prepared remarks.

House lawmakers asked Hamburg yesterday during a contentious hearing why her agency hadn’t done more to rein in New England Compounding Pharmacy, known as NECC, when it had the chance. Inspection reports show that the risk of illness from drugs produced at the Framingham, Massachusetts-based company was known by the FDA as early as 2002.

The FDA sent NECC a warning letter in 2006 in which the agency said it could shut down the business if the pharmacy failed to correct business practices that involved copying certain drugs without permission. House lawmakers were visibly frustrated by Hamburg’s characterization of her agency’s authority as complex to explain why the FDA didn’t shutter NECC then.

Hamburg is scheduled to speak again before the Senate panel, as is Lauren Smith, interim commissioner of the Massachusetts Department of Public Health.

Records Inspection

Compounding pharmacies are supposed to mix drugs based on individual patient prescriptions for treatments that commercial manufacturers don’t make available. Massachusetts regulators have moved to permanently revoke the license of NECC, citing business practices that may have exceeded the scale and scope that is typically allowed.

The company had suspended operations Oct. 3 and recalled 17,676 doses of the steroid methylprednisolone acetate after being linked to meningitis cases. NECC co-owner Barry Cadden appeared at yesterday’s hearing and declined to answer questions from lawmakers, citing his constitutional rights. He’s listed as a witness for today’s hearing.

Legislation Sought

Hamburg asked Congress yesterday to pass legislation granting the FDA the ability to inspect the records of compounding pharmacies and test their drugs and require those that operate on a larger scale by producing treatments in anticipation of prescriptions to register with the FDA. She also asked that compounding pharmacies that practice outside the traditional scope be required to adhere to the agency’s standards for manufacturing.

Hospital pharmacists weren’t specific about what type of FDA regulation they would support. Miller, with the compounders’ lobbying group, on the other hand, said he wouldn’t support registration requirements and that the agency already had the other powers it sought when pharmacies act like manufacturers.

House Republicans didn’t show much interest yesterday in legislation also claiming the FDA had the authority it needed to shut NECC down.

“We might not get legislation,” Representative Cliff Stearns, the Florida Republican who leads the House subcommittee that held the hearing yesterday “The Republicans control the House. The Democrats control the Senate. It will be very difficult.”

To contact the reporter on this story: Anna Edney in Washington at

To contact the editor responsible for this story: Reg Gale at

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