FDA Does Not Use Advisory Committees Effectively PDF Print E-mail

FDA Does Not Use Advisory Committees Effectively in Approving New Drugs, Public Citizen Writes in Lancet Medical Journal

FDA Follows Committee Recommendations Only 72 Percent of Time, Does Not Present Its Own Reviews 18 Percent of Time

WASHINGTON, D.C. - The U.S. Food and Drug Administration (FDA) is not using its own advisory committees effectively when considering the approval of new drugs, according to a Public Citizen study, the results of which are published in a letter in the current edition of the Lancet medical journal. The study of drug advisory committee meetings found that the FDA overrules the findings of its own advisory panels 28 percent of the time, a figure higher than is generally assumed.

To read the entire press release, click here

Even more, click the 'Read More' button below.

FDA Proposal for Painkiller Warning Is Decades Late

Dec. 19, 2006

Statement of Dr. Peter Lurie, Deputy Director of Public Citizen’s Health Research Group

Finally, the Food and Drug Administration (FDA) is proposing to put labels on over-the-counter pain relievers warning of the potential for stomach bleeding and liver damage.

Our major question is: What took the agency so long?

To read the entire statement, click here


FDA APPROVED (Another Farce!) 

Silicone Gel Breast Implants: Most Defective Medical Device Ever Approved by the FDA

Nov. 17, 2006

Statement of Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group

Public Citizen has opposed the use of silicone gel breast implants since the fall of 1988, when we petitioned the Food and Drug Administration (FDA) to ban them after receiving numerous documents from FDA scientists concerned about their safety.

In terms of adverse safety and health information known at the time of approval – such as high rates of rupture, the need for repeat surgery and clear evidence of lymph node infiltration and damage by leaked silicone – silicone gel breast implants are the most defective medical device ever approved by the FDA. The approval makes a mockery of the legal standard that requires “reasonable assurance of safety.”

It is a terrible reminder of the double standard for women versus men that the FDA has not approved silicone gel testicular implants because of the inadequacy of clinical trials on these devices. (Saline breast implants and testicular implants have been approved by the FDA.)

This approval of such a defective medical device raises again the larger issue of the poor leadership and dangerously poor performance of the FDA’s Center for Devices and Radiological Health (CDRH). Recent examples of this include the large number of defibrillator and pacemaker recalls, primarily the fault of manufacturers such as Guidant but abetted by the lack of FDA promptness, and the approval of the vagus nerve stimulator for depression despite the opposition of dozens of FDA staffers because it lacked evidence of effectiveness.

We will certainly be urging thorough congressional investigations and hearings on this lack of assertion of regulatory authority by the FDA’s CDRH.

FDA’s Delay on Plan B Contraceptive Pill Is Another Black Mark Against Troubled Watchdog Agency

August 24, 2006

Statement of Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group

    The Food and Drug Administration’s inexcusable delay in approving over-the-counter sales of Plan B, the “morning after” pill, has caused more damage to its reputation and public confidence in the agency. The delay was caused by political pressure from social conservatives and the religious right that trumped scientific judgment, inevitably resulting in many abortions in women who otherwise would not have become pregnant.

    The troubled agency is already under fire for accepting as much as $380 million a year in users’ fees from industries it is regulating, and allowing dangerous drugs on the market that 15 years ago would either have been banned or not approved in the first place. Some in the agency view industry as a client, clearly ignoring the inherent conflict of interest. The FDA’s watchdog function and the public’s health will continue to suffer because politics and profit margins have increasingly replaced science in decision-making.

Public Citizen Sues FDA Over Secrecy on Blood Substitute Meeting

July 13, 2006

Move to Hold Closed Advisory Meeting on Proposal to Test Blood
Substitute Product on Civilian Trauma Patients Is Unlawful

    WASHINGTON, D.C. – Public Citizen filed an emergency suit last
night against the U.S. Food and Drug Administration (FDA) to force the
agency to open a closed meeting scheduled for Friday, July 14, on an
experimental blood substitute product.

To read the entire press release, click here