FDA Update on Review of Antidepressants Used as Tool for Drug Companies to Seek Pediatric Approval for Antidepressant Use in Children

Patricia Weathers
President
www.ablechild.org
(845) 677-8115

Sheila Matthews
National Vice President
www.ablechild.org
(203) 966-8419

 AbleChild.org Requests that the FDA Withdraw Antidepressant Drug Applications that Seek Drug Approval at Upcoming Advisory Review Committee Meeting on September 13th and 14th, 2004 in Bethesda, Maryland.

According to the FDA’s Talk Paper on the safety review of antidepressants dated August 20th, there are findings among drug trials that suggest an increase risk of suicide in children, but interpretation of these findings represents a “substantial challenge”. Despite these findings, and the fact that the UK last year banned the use of 8 of these antidepressants for use in children, the FDA has attached to their Talk Paper, applications from drug companies, which seek to approve these same drugs for children. (See link attachment on FDA Talk Paper http://www.fda.gov/cder/pediatric/Summaryreview.htm).

The fact is that these drugs have never been approved for use in children. These drugs were being prescribed in what is termed an “off-label loophole”, whereby a doctor could prescribe any of these drugs for a child at his own discretion.

With these facts, and the link to suicide in children, the America public should be alarmed that the FDA is allowing these drug applications to be considered during this safety review process.

“As part of its commitment to keep the American public fully informed about the status of its review of data concerning the use of antidepressants in pediatric patients, the FDA is issuing this update to provide healthcare providers and patients with the most current information on this topic.”

How is this statement fulfilling the FDA’s commitment to fully inform the public, when in fact, they are simultaneously submitting new applications from various drugs companies that would approve the use of these same drugs for children? There was a total of 203 press alerts across the wires yesterday on the FDA’s Safety Update on Antidepressants, all of which excluded the “fine print” located at the bottom of the FDA’s Talk Paper that links new applications to the safety review process. Is this the FDA’s commitment to fully inform the American public?

“The FDA will assure that the labels of the antidepressants used in pediatric patients reflect the most recent information obtained from these same studies and analyses”.

Let’s get to the plan at hand. Is it the intent of the FDA to approve these suicide-linked drugs for use in children, and then slap warning labels on the package after approval?

The September FDA Advisory Committee Meeting that is conducting this review should be acting in accordance with U.S. Code Title 42: Section 289a-1: Part H – General Provisions regarding review and approval of proposal for research under Section (b) Ethical Review of Research. This Advisory Committee has an obligation to the protection of human research and under section (2) the peer review and in the case of any proposal for the National Institutes of Health to conduct or support research; the Secretary may not approve or fund any proposal that is subject to technical and scientific peer review.

Based on these procedural safeguards and guidelines, these antidepressant drug applications that seek drug approval for use in children should be withdrawn immediately from the September FDA Advisory Committee Meeting Agenda.

As a public health agency, the FDA must protect public health, not manage risks associated with depression that goes untreated, especially when that “treatment” itself is inducing suicide ideation that results in death.

It appears the pending strategy seems to be, approve the drugs for use in children, and then warn of risks. This is unacceptable.