Food and Drug Adminstration Truth Watch

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

I would argue that the FDA as currently configured is incapable of protecting America....

— Dr. David Graham
Associate Director of Science
Office of Drug Safety
Center for Drug Evaluation and Research
Food and Drug Administration
(congressional testimony)
Nov. 18, 2004

Key FDA Links
FDA Broadcasts (search engine) FDA Dockets Management (search engine)
FDA Freedom of Information Requests
FDA Web View: The Internet's Fastest FDA News Center
The FDA Advisory Committee.com

Key FDA Personnel to Monitor
Dr. Russell Katz
Dr. Thomas Laughren
Dr. Robert Temple
Dr. Janet Woodcock

Key FDA Committees to Watch
Drug Safety and Risk Mgmt Advisory Committee
Pediatrics Anti-Infective Drugs Advisory Subcommittee
Pediatrics Subcommittee
Peripheral and Central Nervous System Drugs Advisory Committee
Psychopharmacologic Drugs Advisory Committee

FDA 2003 - 2005: A Selection of Key Meetings & Press Releases

(10/10/03)
Antidepressant Suicidality Event Classification Substantially Different Across Sponsor Programs, FDA Tells Cmte

(10/10/03)
Antidepressant Reports Of Suicidality In Children Topic Of FDA Feb. Cmte. Meeting

(2/2/04)
Antidepressant Risk Of Suicidality In Pediatric Patients

(2/4/04)
Antidepressant Strengthened Warnings About Pediatric Suicidality Risk Needed Immediately, Cmte. Says

Click here to see a transcript of the Feb 2nd FDA Pediatric Suicidality meeting (large document)

(4/22/04)
SSRI Antidepressant Effects On Infants Will Be Discussed At June 9 Pediatric Subcmte.

(6/8/04)
Pediatric Subcommittee To Consider Neonatal Antidepressant Withdrawal

(6/9/04)
SSRI Antidepressant Pregnancy Exposure Risks Should Be Communicated In Patient Labeling, Subcmte. Says

Click here to see a transcript of the June 9th FDA SSRI Pregnancy Exposure Risks meeting (large document)

(9/13/2004)
FDA Pediatric Antidepressant Suicidality Data Review Day 1

(9/14/2004)
FDA Pediatric Antidepressant Suicidality Data Review Day 2

(9/15/2004)
"Black Box" SSRI Suicide Warning for Pediatric Patients Recommended By Joint Cmte.

Click here to see a transcript of the Sept 13th-14th FDA Pediatric Suicidality meeting (large document)

(5/26/2005)
Adult SSRI Use And Suicidality To Get Committee Review In Next Few Months, J&J Says

Select FDA Web Site Searches

GlaxoSmithKline
SmithKline Beecham