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Hospitals Seek to Close Gray Area for Drug Compounders

Hospital pharmacists said compounding unique versions of medicines on a large scale creates a gray area between manufacturing and supplying drugs that Congress must clear up following the meningitis outbreak.

“The distinction between traditional pharmacy compounding and manufacturing appears to be a regulatory gray area,” Kasey Thompson, vice president of policy at the American Society of Health-System Pharmacists, said today in prepared testimony for a Senate committee hearing in Washington. “There may be a need for a special category” of oversight that falls between compounding and manufacturing, she said.

Congress is investigating the oversight of compounding pharmacies that mix drugs on a large scale in anticipation of prescriptions, rather than adhering to their traditional role of responding to individual doctor’s orders. Lawmakers said they have received more than 10,000 pages of documents showing that the company at the center of this year’s U.S. meningitis outbreak, New England Compounding Pharmacy Inc., had a history of not complying with state and federal law.

“This case represents a catastrophic failure of regulatory agencies,” Senator Michael Enzi, a Republican from Wyoming, said at a hearing of the Senate’s health committee.

FDA’s Role

Enzi’s comments began a second day of congressional hearings that lambasted FDA Commissioner Margaret Hamburg for failing to shut down New England Compounding, despite a warning letter sent by the agency in 2006 asking the company to modify its business practices. NECC voluntarily suspended operations on Oct. 3 of this year and recalled 17,676 doses of the steroid methylprednisolone acetate after being linked to meningitis cases.

Why “send the warning letters if you can’t act on them?” Senator Pat Roberts, a Republican from Kansas, asked Hamburg. “Why do we even have an FDA and why do you have a job if the FDA can’t stop back alley large-scale drug manufacturing that it knows about?”

Hamburg defended her agency, saying that while the FDA has the power to inspect such facilities, states have the ultimate authority and there is no legislative framework to hold these compounders to a set of federal standards.

“We have authority, but it is limited, unclear and contested,” Hamburg told members of the committee.

Patient Risk

Much like Hamburg did yesterday at a House hearing, the Health-System Pharmacists group told the Senate committee that compounders producing large amounts of medicines may need federal regulation once their activities “advance along the continuum to manufacturing and the risk to patient safety and public health increases.”

The International Academy of Compounding Pharmacists, the industry’s main lobbying group, said expanded federal authority may not be necessary.

“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. He said the FDA already has the authority it needs.

2006 Letter

House lawmakers asked Hamburg yesterday during a hearing why her agency hadn’t done more to rein in 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.

In the 2006 letter, the FDA said it could shut down the business if the pharmacy failed to correct business practices that involved copying certain drugs without permission. 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.

The Massachusetts board and FDA appear not to have taken the necessary steps to protect the public, said Senator Tom Harkin, a Democrat from Iowa. He questioned why products from compounding pharmacies that are sent outside a state’s boundaries don’t fall under FDA’s jurisdiction.

Massachusetts regulators last month 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 already voluntarily suspended operations Oct. 3 and recalled 17,676 doses of the steroid methylprednisolone acetate after being linked to meningitis cases.

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. She also asked that those companies that operate on a larger scale by producing treatments in anticipation of prescriptions be required to register with the FDA. Compounding pharmacies that practice outside the traditional scope also should be made 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.”

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