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