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Nov. 2, 2012 

FDA Still Offering Excuses and Dodging Responsibility for Its Failed Oversight that Allowed Fungal Meningitis Outbreak to Occur

Statement of Dr. Michael Carome, Deputy Director of Public Citizen’s Health Research Group

Late Thursday, the U.S. Food and Drug Administration (FDA) issued a statement expressing concern about an announcement by Ameridose that the company has voluntarily recalled all of its products after FDA inspectors found deficiencies in the company’s testing process for ensuring that its products were sterile.

Ameridose is owned by the some of the same people who own and operated the New England Compounding Center (NECC) in Framingham, Mass. The NECC is the manufacturer of the tainted injectable steroid drugs linked to the growing fungal meningitis outbreak that has so far sickened 386 patients, killing 28.

Media reports of the Ameridose recall indicate that the FDA expressed concern that this recall will worsen existing shortages of sterile injectable drugs. Indeed, Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, told The New York Times that “We have to balance the risk of lack of sterility assurance against the issues of products not being available. That’s a line we walk every day.”

This statement by one of the most senior FDA officials suggests that the agency is willing, in the face of drug shortages, to turn over production of drugs from mainstream drug manufacturers that are held by the agency to the rigorous regulatory standards for drug approval and manufacturing to companies that have not been—but under FDA’s existing legal authority could and should have been—held to those same high standards.

Moreover, the FDA may previously have used concerns about drug shortages as an excuse to ineffectively regulate those drug manufacturing companies that acted under the guise of compounding pharmacies and engaged in large-scale production and national distribution of standardized versions of drugs without being required to adhere to established safety standards.

Any such decisions by the agency may well have contributed to the circumstances that allowed the current public health catastrophe to occur. 

Drug shortages often result when mainstream manufacturers of commercially available, FDA-approved drugs are cited for violations of the good manufacturing practice (GMP) regulations and need to upgrade their manufacturing facilities and procedures. The FDA should not permit compounding pharmacies to fill this gap because these companies have not demonstrated that their compounded products are safe and effective or, with limited exceptions, that they are manufactured in accordance with GMP regulations. This is particularly true when uses of many of these drugs are elective and, in many cases, other commercially available FDA-approved versions are available or could become available through manufacturers that abide by the GMP regulations.

Allowing compounding pharmacies to take over market share for a drug also may discourage commercial mainstream drug manufacturers from resuming production of FDA-approved, higher-quality versions of drugs.

Furthermore, many compounding pharmacies are involved in the large-scale production and distribution of many drugs for which there is no shortage.

Public Citizen again calls on Congress and the Department of Health and Human Services’ Office of Inspector General to conduct independent investigations into the role of the FDA’s lack of oversight as a factor that contributed to the fungal meningitis outbreak.

To read our October 24, 2012, letter to the Secretary of Health and Human Services calling for an independent investigation of the FDA, visit http://www.citizen.org/hrg2080

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