HEALTH AND SAFETY

» 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

 

Read our outrages

Outrage of the Month


If you're not outraged, you're not paying attention!

Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.

 

FDA Cautious on Food Safety, Reckless on Drug Safety

April 2010

Sidney M. Wolfe, M.D.

The Food and Drug Administration (FDA) has brought welcome, increased focus and action to protect people from unsafe or possibly unsafe foods. The most recent example is the massive recall of products containing hydrolyzed vegetable protein, in which the FDA stated that although “no illnesses are known to be associated with this problem of [salmonella bacterial] contamination,” the agency was “taking steps to protect the public.”

In contrast to becoming more active and cautious in enhancing food safety by removing potentially dangerous products before they have caused harm, several FDA decisions in the past year regarding prescription drugs can only be described as reckless. By deciding not to ban three drugs in particular, the FDA has endangered the lives and health of hundreds of thousands of people. For each of these drugs there is unequivocal evidence that their dangers, resulting collectively in hundreds of deaths each year, clearly outweigh their health benefits.

This evidence is so clear that two of the drugs — the pain killer propoxyphene (included in Darvocet) and the diet drug sibutramine (Meridia) — have already been removed (propoxyphene) or removal has been recommended (sibutramine) from the market in the U.K. and in Europe. The American and European diabetes associations recommended a year ago that the third drug, the diabetes drug Avandia, should not be used. In 2009, there were approximately 23 million prescriptions filled for these three drugs in the U.S.

Why is the FDA cautious on food safety but reckless on prescription drug safety? The agency has clearly made a decision to take the lead and insist on a more public health protective effort in the food area. But it has deferred to the existing, dangerously flawed leadership in FDA’s Center for Drug Evaluation and Research (CDER). For foods with possible harm but no evidence yet, there have been recalls, but for these three drugs with thecertainty of harm already having been established and other countries acting accordingly for two of them, the FDA seems incapable of protecting the public.

The top leaders in the FDA, Commissioner Margaret Hamburg and Principal Deputy Commissioner Joshua Sharfstein, stated last year that the “overriding purpose [of the FDA is] protecting the public health,” and that “some benefits are not worth the risk.” Unless this statement is empty rhetoric with regard to drugs, Hamburg and Sharfstein must insist on the ban of these three drugs, as we have previously petitioned the agency to do. Until this is done, they will be complicit, as leaders of the FDA, in the needless, preventable deaths of hundreds or more people a year from drugs with no unique benefits, only unique, life-threatening risks.

Copyright © 2014 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.