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WASHINGTON, D.C. - U.S. Rep. Bart Stupak on Thursday criticized the U.S. Food and Drug Administration for its lack of oversight of antidepressants that are prescribed to children.
Stupak, a Democrat who represents Cheboygan County, spoke at a House Oversight and Investigation Subcommittee hearing regarding the pharmaceutical industry and the FDA's role in disclosing drug studies of antidepressants. He said the agency has repeatedly failed doctors, patients and parents.
"There is no room for incompetence or complacency when it comes to the safety of our children," Stupak said before the panel. "Disclosure of all drug trials must be swift, it must be complete, and it must be understandable to physicians and parents alike."
He cited recent reviews that have found possible links between suicidal behavior in children and the antidepressants they were taking.
Stupak became an advocate for such disclosure after his son, Bart Stupak Jr., committed suicide at the family home in Menominee in May of 2000. B.J., as he was known, had 11 more Accutane pills to take to complete his prescription to treat acute acne. After B.J.'s death, his parents discovered that Accutane use among teenagers was linked to suicides and suicidal thoughts.
Studies on antidepressants have found that all but one of the drugs used provide only as much benefit to children as sugar pills, while at the same time increasing suicidal behavior in some young patients, Stupak said. Meanwhile, he explained, the FDA has failed to act quickly to make the information available to doctors and parents and to require the appropriate changes to drug labels.
"Physicians and parents deserve a full accounting of the research from the FDA and the drug companies about the risks and benefits of these drugs, but that's not happening," Stupak said. "Drug companies, aided by FDA complacency, gave them no reason to question the safety or effectiveness of these drugs."
Stupak said drug companies can "cherry-pick" which studies they publish.
He also pointed out that the FDA is not enforcing the laws that require studies. Stupak cited one law in particular, the Best Pharmaceuticals for Children Act, which allows drug companies to receive patent extensions if they agree to study the effect of a particular drug on children.
However, the FDA had not published the summaries of the studies of five antidepressants until late in August. The agency published the drug study summary for just one, Effexor, and that study failed to mention the suicidal behavior link, Stupak stated.
In addition, the law doesn't require that drug summaries be completed before the patent extension is issued.
"We have it backwards," Stupak testified Thursday. "The patent extension should only occur if the drug is safe, effective and if necessary label changes are fully implemented."
Stupak unsuccessfully offered an amendment to make that specific change in 2002.
Later this month, an FDA advisory committee will meet to discuss recommendations about the safety and effectiveness of antidepressants on children and possible labeling requirements. The House subcommittee will then hold a second hearing on the FDA's suggestions.
"Congress will not sit back if the drug companies and FDA ignore or are slow to implement those recommendations by the advisory committee," Stupak said. "We cannot allow profits and stock prices to trump the safety of our children. This complacency must end.
"Unfortunately, as we know from Accutane, that the FDA most often simply chooses to ignore the Advisory Committees'' recommendations," he added.
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