Columbia University Medical Center
NewYork-Presbyterian Hospital The University Hospital of Columbia and Cornell
July 5, 2009

This cross-specialty advisory committee consisted of members from the FDA's psychopharmacologic drugs, pediatric, cardiovascular and renal drugs, drug safety and risk management, and endocrinologic and metabolic drugs advisory committees.

During the open public hearing, David Fassler, M.D., APA secretary-treasurer and a child and adolescent psychiatrist, urged the FDA to "consider the reality of how medications are used in the treatment of children and adolescents with complex psychiatric disorders ... and to limit any specific indication approval to short-term, episodic use consistent with the data presented." He also recommended that the FDA require the companies that make the SGAs to conduct phase-4 trials to evaluate long-term outcomes associated with these drugs. Fassler was testifying on behalf of APA.

Laurence Greenhill, M.D., president of the American Academy of Child and Adolescent Psychiatry, also spoke at the public hearing. He urged the FDA to require a registry for the use of these antipsychotics in children and adolescents so that more long-term data on the safety and efficacy can be centrally collected and monitored. Currently, a national registry is in place for clozapine use because of its potentially fatal side effect.

Read more at Psychiatric News">Read more at Psychiatric News


chronos interior