Mr. Chairman, thank you for initiating this investigation and holding the first of this Subcommittee's hearings into the safety and efficacy of anti-depressants in adolescents and related issues. Today's hearing focuses on efficacy. Specifically, whether parents, pediatricians, and other physicians who treat children with anti-depressant drugs should have been notified of the repeated failure of clinical trials to show that these medicines, with a single exception, are effective in adolescents and how such notice should have been provided.

We are told that the Food and Drug Administration (FDA) does not believe that these very potent drugs, which are labeled as a treatment for severe depression in adults, need to be labeled as clinical trial failures for children. Is withholding this information in the best interests of patients? Or is it in the best interest of the drug companies that are supposed to be regulated by the FDA? It becomes an even more relevant question when we know that those trials were paid for by billions of dollars from the pockets of consumers and taxpayers.

Today we will explore how the drug manufacturers and the FDA justify not providing to parents and doctors the evidence of the ineffectiveness and dangerous side effects of these powerful drugs on children. We will not only ask why the FDA and the manufacturers failed to provide this important information on the label, but why the FDA ignored the minimal public disclosure requirement in the pediatric exclusivity legislation.

I opposed giving drug companies additional monopoly profits in order to induce them to test their drugs on children when the "Best Pharmaceuticals for Children Act" was passed last Congress. During the debate a number of logical amendments were offered that would have mitigated the giveaway or at least imposed minimal labeling requirements upon the beneficiaries of that Act. The pharmaceutical industry opposed every amendment, as did their allies in the Administration.

Since enactment of the law, study after study of dubious design has been submitted and apparently approved by those responsible for protecting children and other citizens from products that are ineffective and cause dangerous side effects. The study designs were dubious because they apparently could never satisfy the FDA that drugs would not work for children and youth regardless of what the data showed. In other words, once the drug had been approved for adults the studies could never show ineffectiveness in children.

This hearing will demonstrate, with the exception of Eli Lilly, that the manufacturers and the FDA went to extraordinary lengths to keep vital information from the public regarding the ineffectiveness of these drugs in children. The hearing scheduled for September 23rd will further show how FDA attempted to hide critical information about the increase in suicides or suicidal ideation by adolescents who were prescribed certain drugs. In both cases, crucial information was withheld by an agency responsible for providing public health information to the doctors and the parents who care for these troubled children.

We need prompt, accurate labeling of all drugs before any exclusivity is granted. I look forward to working with my colleagues on legislation to make sure doctors and parents have the information they need and expect, and that the FDA and drug manufacturers uphold their responsibilities to the public.