Florida To FDA: No Foster Kids In Psychotropic Trials

Florida To FDA: No Foster Kids In Psychotropic Trials

By Ed Silverman // July 19th, 2010 // 8:56 am
Last year, a 7-year-old foster boy named Gabriel Myers committed suicide in Florida and, after reams of publicity and hand-wringing over the use of psychotropic medications in such children, a state task force recommended, among other things, that children never be allowed to participate in a clinical trial designed to evaluate new psychotropic meds or whether such drugs approved for adults should be given to children.
The move was prompted, in part, because a Florida psychiatrist, Sohail Punjwani, who treated the boy before he committed suicide, received an FDA warning letter for failing “to protect the rights, safety and welfare” of children enrolled in clinical trials (back story). Before the suicide, the psychiatrist prescribed to kids several drugs, some of which weren’t approved by the FDA for use on children and had been linked to dangerous side effects, including an increased risk of suicide among children (back story).
As part of the follow-up, George Sheldon, who head’s Florida’s Department of Children and Families, wrote FDA commish Margaret Hamburg for info about any foster children who might have participated in clinical trials for psychotropic meds (read the letter) and asked the FDA to forbid foster kids from participating in these trials. Last month, the agency wrote back to say the agency does not agree with a “blanket prohibition” on enrolling foster children. Why? Such a policy fails to account for the greater risk of off-label prescribing and research involving children can yield benefits that cannot be obtained by tracking usage in adults, Jill Warner, acting associate commissioner for the FDA’s Special Medical Programs, wrote back (see here). Drugmakers, by the way, also have something at stake - they receive an extra six months of marketing exclusivity in return for having conducted the pediatric trials.
We asked Florida officials if they are rethinking their position. The answer? No way. The state is resolute. A department spokeswoman writes us to say this: “There is no impasse. While we appreciate the information provided by the Food and Drug Administration, the Department of Children and Families, not the FDA, is responsible for the protection of children in its care and takes those responsibilities extremely seriously. To that end, we have, by administrative procedures, prohibited the use of children in state care in clinical trials relating to the development of new psychotropic medications.
“Additionally, this Department’s operating procedure on ‘Institutional Oversight of Human Subject Research and Institutional Review Board Designation’ now further specifies: “At no time shall a child in the custody of the Department be allowed to participate in a clinical trial that is designed to develop new psychotropic medications or evaluate the suitability of providing medications previously approved for adults to children” (read more here). She adds that the department expects to send a formal response to the FDA in the “immediate future.” What do you think?

http://www.pharmalot.com/2010/07/florida-tells-fda-no-children-in-psychotropic-trials/