The Honorable Margaret A. Hamburg
U.S. Food and Drug Administration
White Oak Building
10903 New Hampshire Avenue
Silver Spring, MD 20993
Via: E-mail Margaret.Hamburg@fda.hhs.gov
Dear Commissioner Hamburg:
The Project On Government Oversight is a nonpartisan independent watchdog that champions good government reforms. We take a keen interest in the U.S. Food and Drug Administration (FDA), which receives around $4 billion a year in federal taxpayer dollars to regulate aspects of almost 25 percent of the U.S. economy.
We are concerned about a letter POGO received this spring from Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the FDA. There is a clear disconnect between what Dr. Woodcock told POGO in the letter and what is happening at the FDA.
POGO sent you a letter on October 25, 2010, alerting the FDA to a potentially dangerous interaction of the drugs Seroquel (quetiapine) and methadone that may be putting veterans at risk. According to news accounts, these drugs are now widely used in combination to treat veterans with Post-Traumatic Stress Disorder (PTSD). We requested that the FDA look into the potential drug interaction, and to issue an alert to inform patients and prescribers.
In her April 15, 2011, response letter, Dr. Woodcock stated that such a potentially dangerous interaction was “exceedingly unlikely” and that the FDA would not be taking any further action regarding “a revision in labeling that would include new warnings or cautions, or targeted public and professional communications efforts.”
Less than two months later, in June 2011, the FDA approved changes to the label for Seroquel to note that the drug “should be avoided in combination with other drugs” such as methadone. (See Attachment A) In light of this FDA action, the letter from Dr. Woodcock in response to our request frankly makes no sense. It is our understanding that changes to a label take anywhere from 3 to 6 months. Given that FDA has to approve label changes, how could Dr. Woodcock not know in April that changes would be made in June?
Again, I remain concerned about the potential for a dangerous interaction of the drugs Seroquel (quetiapine) and methadone that may be putting veterans at risk. These drugs are widely used to treat veterans with PTSD. An investigation by The Military Times found that military spending on Seroquel almost quadrupled between 2001 and 2009. In a separate story, The Military Times found that methadone overdose has caused at least sixty deaths in the military, more than any other drug—legal or illegal.
POGO is pleased that the FDA has made progress by requiring the label changes, but requests once again that the FDA issue an action alert to inform patients and prescribers about the risk. Given the FDA-approved changes to Seroquel’s labeling, we would imagine this would be a natural next step for FDA.
I also request an explanation for the response we received from Dr. Woodcock in April denying the need for a “revision in labeling” given the changes to Seroquel’s label just two months later.
I appreciate your review of this letter and the attached documents. If you have any questions, please do not hesitate to contact Paul Thacker at email@example.com or (202) 347-1122.
cc: Senator Carl Levin, Chairman, Senate Armed Services Committee
Senator John McCain, Ranking Member, Senate Armed Services Committee
Senator Patty Murray, Chairman, Senate Veterans’ Affairs Committee
Senator Richard Burr, Ranking Member, Senate Veterans’ Affairs Committee
The Honorable Eric K Shinseki, Secretary, Department of Veterans Affairs
Dr. Jonathan Woodson, Assistant Secretary of Defense (Health Affairs), Department of Defense
 Letter to Danielle Brian, Executive Director, Project On Government Oversight, from Dr. Janet Woodcock, April 15, 2011.
 Letter to The Honorable Margaret A. Hamburg, Commissioner, U.S. Food and Drug Administration, from the Project On Government Oversight, October 25, 2010.
 For instance, see Andrew Tilghman and Brendan McGarry, “Medicating the Military: Use of Psychiatric Drugs has Spiked; Concerns Surface about Suicide, other Dangers,” Army Times, March 17, 2010. (hereinafter “Medicating the Military”)