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Will the FDA Follow Guidelines For Safety Review of Antidepressant Use In Children?

Patricia Weathers 845-677-8115

Sheila Matthews 203-966-8419
National Vice President

The FDA’s hearings on February 2, 2004, regarding the safety review process of today’s mass marketed antidepressants otherwise known as SSRI’s (Selective Serotonin Reuptake Inhibitors) has led us to question what guidelines are being followed by the administration that would ensure due process in obtaining a determination that will affect our children’s overall health and well being.

February 2, 2004 marks the day that parents and children implored the FDA to listen to their stories of personal tragedies regarding antidepressants and view them as a wake up call, one that would require immediate action. Sadly, parents need a hitter, but the administration appears to be lingering on the sidelines stating that it would not be making a decision anytime soon.

Parents might have to wait a dangerously long period-of-time for the administration to give a final answer, which possibly could occur sometime in late summer. Until then, the FDA has advised doctors to use great caution if they prescribe any antidepressants to anyone under age 18. This is unacceptable.

The FDA must be held accountable for following guidelines regulating the safety review process that governors what they can and cannot do and their ability to move forward in an unbiased manner in addressing the emerging issues related to drug development, testing and safety. The FDA needs to adhere to the United State Code – Title 42, Section 289a-1: Part H – General Provisions regulating any and all actions that need to be taken regarding safety review of drug research.

Is the administration on the same page with us regarding the guidelines that govern the review process?

Parents look to specific written rules that govern the FDA’s safety review process that relates to drug research outlined within US Code 42, Section 289A-1, Part H: General Provisions. As with free elections, the public must be able to rely on some type of written rules to ensure the process is open and reliable.

Under US Code 42, parameters are in place regarding how the FDA can act. One such area is the FDA’s choice of a review panel. The composition of this panel or “the ethics board for review” should consist of specific review panel members. The public should be aware that there should be in place at least one attorney, a minimum of one ethicist, at least one practicing physician, one theologian, and no less than 1/3 and no more than 1/2 of scientists with substantial interest in biomedical or behavioral research. The translation of this should be quite clear: The FDA cannot arbitrarily choose just anybody for this review panel.

Within the general guidelines, there are also time sensitive dates, such as- an ethics board termination schedule, that must be highlighted in lieu of the FDA’s announcement that they will not be able to give an outcome any time soon. Parents are concerned that the FDA is bypassing time sensitive dates and the structural make-up of the review board in hopes of protecting special interest groups. The safety reviews are governed by due process and parents expect the administration to hold our children’s basic safety above special interest group agendas.

The FDA should be held accountable for informing the public as to how they will proceed under the federal guidelines clearly set-up to govern their actions. At the very least, they should inform the public as to which type of review will take place according to these provisions.

The FDA stated in its recent memorandum:

“The FDA relies on the knowledge, judgment, experience, and wisdom of scientists and practitioners like you to help determine how to move forward and address newly emerging issues related to drug development. We thank you for your time and effort, and we look forward to seeing and hearing from you on Feb 2nd.”

This closing statement, we believe, clearly demonstrates the administration falling several feet short of meeting the expectations outlined within the US Code. We question the FDA’s actions and ask it to supply the answers to show that it is operating within the guidelines that regulate the safety review process. After all, the public is entitled to know if the FDA is following this basic safety review process outlined within the U.S. Code.

It is very clear to us what the FDA needs to do and the parameters that regulate how they need to do it. In the same token, is it clear to the FDA?