Learn more about our policy experts.

Media Contacts

Angela Bradbery, Director of Communications
w. (202) 588-7741
c. (202) 503-6768
abradbery@citizen.org, Twitter

Don Owens, Deputy Director of Communications
w. (202) 588-7767

Karilyn Gower, Press Officer
w. (202) 588-7779

David Rosen, Press Officer, Regulatory Affairs
w. (202) 588-7742

Other Important Links

Press Release Database
Citizen Vox blog
Texas Vox blog
Consumer Law and Policy blog
Energy Vox blog
Eyes on Trade blog

Follow us on Twitter


Oct. 24, 2012

Public Citizen Calls for Independent Investigation of FDA’s Failure to Regulate Pharmacy Practice at Heart of Meningitis Outbreak

FDA Statements in Aftermath Appear Deliberately Misleading on Agency’s Authority to Regulate

WASHINGTON, D.C. – The U.S. Department of Health and Human Services (HHS) Office of Inspector General should open an independent investigation into how the Food and Drug Administration (FDA) failed to use its established regulatory authority to protect the public from the dangerous practice of large-scale drug compounding that led to the widening fungal meningitis outbreak caused by tainted steroid injections, Public Citizen said today in a letter addressed to HHS Secretary Kathleen Sebelius.

Citing statements made by an FDA official during a teleconference with journalists reported by The Washington Post, Public Citizen strongly condemned the FDA for making misleading statements to the public; in particular claiming to lack “clear authority to take action earlier against” the New England Compounding Center (NECC), the company that produced large quantities of the contaminated steroid drug linked to the ongoing meningitis outbreak. In addition to other unnamed officials, the article quoted Deputy FDA Commissioner for Global Regulatory Operations and Policy Deborah M. Autor as saying it was “really unfortunate that it sometimes takes a tragedy” to bring about change and calling for a “new regulatory scheme that appropriately controls the risk.”

“This attempt by one of the most senior figures within the FDA to deflect criticism for FDA failures that contributed to the meningitis outbreak is deeply troubling,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “The claims by agency officials that the FDA lacks authority to properly regulate compounding pharmacies is contradicted by a long history of remarkably consistent statements and enforcement actions asserting the agency’s legal authority over such pharmacies.”

Prior warning letters from the FDA to several compounding pharmacies over the past decade, including one to the NECC in 2006, indicate that the agency considered these pharmacies to be engaged in drug manufacturing. The pharmacies were therefore considered by the FDA to be subject to the safety and effectiveness standards required for approval of new drugs, as well as the rigorous manufacturing standards designed to ensure that drugs are sterile and uncontaminated with such germs as bacteria or fungi before being sold and distributed.

“Given its attempts to dodge responsibility in this matter, the FDA is clearly incapable of conducting an objective evaluation of its own policy, oversight, and enforcement decisions, which no doubt contributed to this ongoing preventable tragedy,” Carome said. “An independent investigation must be conducted and should identify all agency officials whose actions and decisions contributed to the FDA’s failure to prevent this public health catastrophe.”


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


You can support the fight for greater government and corporate accountability through a donation to either Public Citizen, Inc., or Public Citizen Foundation, Inc.

Public Citizen lobbies Congress and federal agencies to advance Public Citizen’s mission of advancing government and corporate accountability. When you make a contribution to Public Citizen, you become a member of Public Citizen, showing your support and entitling you to benefits such as Public Citizen News. Contributions to Public Citizen are not tax-deductible.

Public Citizen Foundation focuses on research, public education, and litigation in support of our mission. By law, the Foundation can engage in only very limited lobbying. Contributions to Public Citizen Foundation are tax-deductible.