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Response to Senate HELP Committee’s Questions Regarding Compounding Pharmacies

View entire letter as PDF.

The Honorable Tom Harkin
U.S. Senate Committee on Health, Education, Labor, and Pensions
731 Hart Senate Office Building
Washington, DC 20510

The Honorable Michael B. Enzi
Ranking Member
U.S. Senate Committee on Health, Education, Labor, and Pensions
379A Russell Senate Office Building
Washington, DC 20510

Re: Questions for Stakeholders Regarding Appropriate Regulation of Pharmacy Compounding

Dear Senators Harkin and Enzi:

Public Citizen, representing more than 300,000 members and supporters nationwide, appreciates the opportunity to respond to the questions regarding pharmacy compounding that were posed by the Senate Committee on Health, Education, Labor, and Pensions (HELP Committee). Please find enclosed our responses to these questions.

The now widely publicized outbreak of life-threatening fungal meningitis in back-pain patients linked to contaminated steroid injections prepared by the New England Compounding Center, a compounding pharmacy located in Massachusetts, highlights the failure of the Food and Drug Administration’s (FDA’s) regulatory oversight of drugs prepared and sold by such pharmacies.

What is particularly tragic for the families of those who have been sickened or killed by the tainted steroid drug is that this situation was completely avoidable given the FDA’s current legal authorities. Indeed, over the last decade, the FDA has been remarkably consistent and unwavering in asserting that the agency has legal authority over compounding pharmacies, particularly those that engage in drug manufacturing through the large-scale production and distribution of standardized versions of drugs.

The HELP Committee and other congressional committees responsible for overseeing the activities of the FDA should fully investigate the role this agency, as well as others, played in allowing the meningitis outbreak to occur. This investigation must identify all FDA officials whose actions and decisions contributed to the agency’s failure to prevent this public health catastrophe. Ultimately, the senior leadership within the Office of the Commissioner, the Center for Drug Evaluation and Research, and the Office of Chief Counsel must be held accountable.

The Congress should await the completion of its investigations before deciding what legislative measures are needed to enhance the regulatory oversight of compounding pharmacies.

Please feel free to contact us if you have any further questions or would like our assistance.


Michael A. Carome, M.D.
Deputy Director
Public Citizen’s Health Research Group

Sarah Sorscher, J.D., M.P.H.
Public Citizen’s Health Research Group

Sidney M. Wolfe, M.D.
Public Citizen’s Health Research Group