» Drug, Devices, and Supplements

» Physician Accountability

» Consumer Product Safety

» Worker Safety

» Health Care Delivery

» Auto and Truck Safety

» Global Access to Medicines

» Infant Formula Marketing


More Information on Compounding Pharmacies

Response to Senate HELP Committee's Questions Regarding Compounding Pharmacies

November 2, 2012

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

Copyright © 2016 Public Citizen. Some rights reserved. Non-commercial use of text and images in which Public Citizen holds the copyright is permitted, with attribution, under the terms and conditions of a Creative Commons License. This Web site is shared by Public Citizen Inc. and Public Citizen Foundation. Learn More about the distinction between these two components of Public Citizen.

Public Citizen, Inc. and Public Citizen Foundation


Together, two separate corporate entities called Public Citizen, Inc. and Public Citizen Foundation, Inc., form Public Citizen. Both entities are part of the same overall organization, and this Web site refers to the two organizations collectively as Public Citizen.

Although the work of the two components overlaps, some activities are done by one component and not the other. The primary distinction is with respect to lobbying activity. Public Citizen, Inc., an IRS § 501(c)(4) entity, lobbies Congress to advance Public Citizen’s mission of protecting public health and safety, advancing government transparency, and urging corporate accountability. Public Citizen Foundation, however, is an IRS § 501(c)(3) organization. Accordingly, its ability to engage in lobbying is limited by federal law, but it may receive donations that are tax-deductible by the contributor. Public Citizen Inc. does most of the lobbying activity discussed on the Public Citizen Web site. Public Citizen Foundation performs most of the litigation and education activities discussed on the Web site.

You may make a contribution to Public Citizen, Inc., Public Citizen Foundation, or both. Contributions to both organizations are used to support our public interest work. However, each Public Citizen component will use only the funds contributed directly to it to carry out the activities it conducts as part of Public Citizen’s mission. Only gifts to the Foundation are tax-deductible. Individuals who want to join Public Citizen should make a contribution to Public Citizen, Inc., which will not be tax deductible.


To become a member of Public Citizen, click here.
To become a member and make an additional tax-deductible donation to Public Citizen Foundation, click here.