Compromise bill announced on regulating drug compounders

Written by

Walter F. Roche Jr.

The Tennessean

A compromise bill that supporters say gives the U.S. Food and Drug Administration great regulatory control over drug compounders has been announced by congressional leaders from both the House and Senate, but it is unclear whether it has the support of the FDA itself.

The compromise was disclosed late Wednesday in press releases issued by U.S. Sen. Lamar Alexander, R-Tenn., and a bipartisan group of House leaders including U.S. Rep. Henry Waxman, a California Democrat.

The agreement comes a year after the beginning of a fungal meningitis outbreak that took the lives of 16 patients treated in Tennessee and 64 nationwide. The deadly outbreak has been blamed on a Massachusetts drug compounding company that shipped fungus-tainted spinal steroids to health-care providers in 20 states.

Industry officials said the compromise had been worked out over the weekend, but expressed concern that the FDA had last-minute objections.

Erica Jefferson, FDA spokeswoman, said she could not immediately comment on the matter. Actual copies of the legislation were not immediately available.

“This bill will prevent Tennessee families from living through another nightmare like last year’s tragic meningitis outbreak,” Alexander said in a prepared statement.

The congressional proposal has drawn criticism from advocacy groups like Washington, D.C.-based Public Citizen. Dr. Michael Carome, who heads the group, said both the House and Senate versions of the bill authorize a new category of drug manufacturers that will face less scrutiny than those now licensed by the FDA. He argues that the FDA already has the authority to regulate large drug compounders but has failed to do so.

Carome said Wednesday that he had yet to see the actual legislation and repeated his concerns.

The bill establishes a category of drug producers called outsourcers who will be authorized to mass-produce compounded drugs without patient-specific prescriptions.

Alexander said the compromise will allow local pharmacies to produce individually compounded drugs as they can now with oversight by state regulators, not the FDA.

The national association representing drug compounders had expressed concerns that previous versions of the bill would give the FDA regulatory authority over individual pharmacies.

David Ball, spokesman for the International Academy of Compounding Pharmacists, said Wednesday that his organization did not yet know the details of the compromise, but had heard of possible FDA objections.

The compromise also includes provisions to create a new prescription drug supply chain tracking system allowing regulators to trace drugs from the manufacturer to local drug stores. The tracking system had been originally proposed in separate legislation and is aimed at preventing counterfeit drugs.

Walter F. Roche Jr. can be reached at 615-259-8086 orwroche@tennessean.com

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