Examining FDA's Review of Safety & Efficacy Concerns in Anti-Depressant Use by Children

"Examining FDA's Review of Safety & Efficacy Concerns in Anti-Depressant Use by Children"

September 23, 2004

Opening Statement Oversight & Investigations Subcommittee Hearing
Mr. Chairman, thank you for calling this second hearing to examine concerns surrounding the safety and efficacy of anti-depressant use by children. This committee must closely examine the FDA's role in reviewing clinical trial data indicating serious side effects associated with certain prescription drugs. The FDA's mission is to protect public health, and therefore it has the responsibility to alert physicians and the public to safety and efficacy concerns associated with various medical treatments.

I find it very troubling that FDA officials appear to have attempted to suppress information indicating that SSRI antidepressants may increase the risk of certain suicide related thoughts and/or behaviors in children. I am disturbed that Dr. Mosholder's full report on this issue, conducted at the behest of the FDA, was not allowed to be presented at FDA's February advisory committee meeting on this issue. I look forward to hearing from Dr. Mosholder about the directive under which he conducted his review on clinical trial data of SSRIs and the conclusions of his report.

Clearly there is debate among the scientific community about whether episodes of attempted suicide while taking SSRIs are attributed to the underlying depression of an individual patient, or to the taking of SSRIs. However, disagreement about clinical trial data does not mean that the studies, and conclusions of specific researchers, should be dismissed or suppressed. Rather, vigorous debate in the scientific community should be encouraged, and conclusions challenged, in order to arrive at the best determination of what information should be disseminated to physicians and their patients.

The increasing rate of clinical depression in children is a serious public health issue. Children diagnosed with depression are clearly at an increased risk for suicidal thoughts and behaviors. Each year more than 500,000 children and adolescences attempt suicide, and approximately 2,000 young people die as a result of suicide.

I had the opportunity to discuss the link between SSRIs use and the possible increase in suicidal thoughts and behavior with a pediatric physiatrist in Maine. He said that there is solid agreement among physicians that they need better clinical data on the side effects of anti-depressants, and not just studies financed by drug manufacturers. He also stressed that physicians need to have a variety of drugs available to them in order to make the best choice for their patients. Research indicates that between 30 and 40 percent of children and adolescents with depression will not respond to the first medication. The debate surrounding this issue clearly indicates a need for greater post-marketing studies on prescription drugs.

I am interested in learning from Dr. Temple about the recent recommendations of the Psychopharmacologic Drugs and Pediatric Advisory Committees, including the suggestion of requiring a "black box" warning on all antidepressant drugs indicating an increased risk for suicidality in pediatric patients.

Certain drugs prescribed to children can be ineffective or dangerous. It is FDA's responsibility to investigate the risks associated with prescription drug use in order to protect the safety of our nations' children. FDA has a critical role in ensuring that doctors and consumers receive balanced information.

I look forward to hearing all of your testimony on this very important topic.