WASHINGTON – Members of a House committee sharply criticized the Food and Drug Administration Thursday for hiding research that linked anti-depressants and suicidal thoughts and behavior among adolescents
“There's something terribly rotten at the FDA,” said Rep. Peter Deutsch,D-Fla.,“and no agency of Congress should ever show the disrespect that the FDA has in the course of this investigation.”
A House Energy and Commerce subcommittee investigating the FDA's role in disseminating new information about children and anti-depressants heard from six agency scientists and officials at an oversight hearing.
According to the committee chairman,Rep. Joe Barton,R-Texas,more than 10 million children are prescribed anti-depressants each year.
The committee heard key testimony from Andrew Mosholder,a safety reviewer for the FDA who was barred from speaking about his research on these drugs at a public meeting in February. After an advisory meeting less than two weeks ago – in which Mosholder was finally allowed to present his findings – the advisory committee suggested that the FDA add warnings to the drugs' labels.
The panel said it recognized an association between anti-depressants,such as Paxil,Prozac and Zoloft,and teen suicide.
According to an FDA statement issued last week and supported by officials at the hearing,the agency “generally supports” its advisory committee's recommendations,and is working to write a new label to warn parents about their children's increased risk of becoming suicidal during the first weeks of therapy.
The agency has not given a specific date for the release of the new black-box warning labels,but Robert Temple,FDA director for medical policy,said it may be as soon as a couple of weeks.
British regulators have banned the use of anti-depressants,with the exception of Prozac,for people less than 18 years old. Mosholder said Prozac is the most effective and least risky anti-depressant on the market.
Committee members,including Rep. Greg Walden,R-Ore.,said they wanted to know why the FDA chose to withhold such vital information. Walden said the FDA has known for several years that anti-depressants were ineffective and potentially risky for children,but the agency has done nothing to alert the public.
“The FDA can't simply sweep this under the carpet or put it in the back corner,” said Rep. Diana DeGette,D-Colo. “I think the FDA has a lot to answer for.”
Temple backed the agency's decision to be cautious in releasing Mosholder's report. He said a more careful review of anti-depressants and the pediatric population is needed because depression is a potentially life-threatening disease,and there are no acceptable alternative treatments.
Mosholder,a doctor of child and adolescent psychiatry,said one reason the FDA could have been hesitant to release information about his studies is that no one knows the long-term effects of anti-depressants on children. He said the drugs may have short-term risks and long-term benefits.
In response to questions,Mosholder said he thought the long-term data question was the reason he was prevented from talking before now and not that anyone doubted his credibility.
Rep. Bart Stupak,D-Mich.,said he is frustrated with the FDA's failure to act quickly.
“When safety is in question,the FDA should err on the side of caution,” he said. “Congress and the American people have had enough of the stonewalling and the excuse-making.”