Despite evidence of harm–including the suicide of a 7-year old Gabriel Myers– the FDA, which is charged with ensuring the safety of children in drug trials, fails to maintain a record of children enrolled in commercial drug trials.

By contrast, after the suicide of Gabriel Myers , a seven-year old boy in foster care who had been prescribed three powerful psychotropic drugs in a dubious clinical trial, George Sheldon, Florida’s Secretary of the Department of Children and Families, examined the records of children in State foster care and found a high percentage being drugged with psychotropic drugs:



"Not only was the percentage high, it was not really known. And, in more than a third of known cases, required approval permission documents were missing."

So he wrote to the FDA–which is responsible for ensuring that children’s involvement in drug trials is approved and understood by parents or guardians who give surrogate consent. The FDA is charged with overseeing pediatric trials conducted under the FDAMA law–a law that awards drug manufacturers who test their drugs in children with an extended, highly lucrative, 6-months of market exclusivity.

Sheldon asked the FDA how many Florida foster children were involved in drug studies as they bounce from foster family to foster family?



The answer encapsulates FDA’s irresponsible approval for the use of children–who are, after all, NON-CONSENTING human beings–without regard for children’s safety.

Drug trials pose known and potential risks of harm, pain, and discomfort. Commercially-driven drug trials rarely offer children a direct benefit.

The Herald Tribune (Florida) reports (below) the response by Jill Hartzler Warner, an associate FDA commissioner, to Sheldon’s question:

"the FDA didn’t have an exact number. Or even an estimate. The FDA, in fact, doesn’t have the slightest idea how many Florida foster kids are or have been involved in its drug studies."

What’s more, Hartzler and the FDA also urged Sheldon "not to bar Florida’s foster kids from drug trials, arguing that benefits can outweigh risks."



Richard Wexler of the National Coalition for Child Protection Reform, says the FDA’s position is absurd.

"I would love to ask Associate Commissioner Hartzler if she’d care to let a total stranger decide if her children should be enrolled in a trial for a potentially dangerous drug."



Does Jill Hartzler Waner’s response represent the official position of FDA and its Commissioner, Dr. Margaret Hamburg?

*Jill Hartzler Warner, J.D., is Acting Associate Commissioner for Special Medical Programs at FDA. She oversees FDA’s Office of Pediatric Therapeutics, Office of Orphan Products Development, Office of Good Clinical Practice, Office of Combination Products, and the Advisory Committee Oversight and Management Staff. In this position, Ms. Warner provides leadership and direction in the coordination of internal and external review of pediatric science, safety, ethics, and international issues.

Vera Hassner Sharav



