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Stupak backs drug label change

Published Monday, September 27, 2004 1:06:01 PM Central Time

WASHINGTON -- U.S. Rep. Bart Stupak, D-Menominee, has called on the Food and Drug Administration to immediately implement a recent FDA Advisory Panel's recommendation to place "black box" labels on antidepressants that warn of possible suicidal behavior by the children who take them. Stupak emphasized that such labeling needs to be easy to understand and able to be seen.

Stupak, who participated in the House hearing relative to those recommendations, also criticized the FDA for suppressing internal agency analysis that found increased rates of suicidal behavior in children who took antidepressants, such as Paxil, Effexor, Zoloft and Celexa. He said the FDA has finally admitted what they've known for a year -- there is an increased risk of suicidal thoughts and behavior in children who take antidepressants.

Stupak says these antidepressants should be banned until it has been proven that they are safe and work. "The American people have a right to demand the FDA look out for their interest and not the interest of the drug companies," he said.

People may not realize that the FDA is under no obligation to implement those recommendations, according to Stupak. "There are many instances when the FDA has ignored or scaled back Advisory Committee recommendations, caving to drug company pressure. I know from my own experience that the FDA has repeatedly ignored Advisory Committee recommendations concerning the acne drug Accutane.

"I am particularly concerned the FDA might back away from the recommendation of package labeling that parents and patients can see and understand. The FDA should require information about the safety and efficacy of these drugs be dispensed with every prescription and on the drug's packaging. The FDA should also require parents to sign an informed consent form before treatment can begin."

Stupak pointed out that in 1997 Congress passed a law beginning a system where drug companies get patent extensions "worth billions of dollars" to study these drugs in children.

"Children, the most vulnerable members of society, are the only group that we grant patent extensions to drug companies in exchange for studies," Stupak charged.

"Patents are extended once pediatric studies are turned into the FDA. There is no requirement that the studies were actually done well, or actually showed whether the drug worked or was safe. And there's no requirement that the package labeling on these drugs is actually changed before the patent extension is granted.

"At the very least, parents should get the facts in exchange for those billions in profits. It's clear today that they aren't," he concluded.

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