According to the AP, a federal advisory panel determined Friday (12/2/05) that the first skin patch to treat attention deficit hyperactivity disorder in children is both effective and safe, bringing the patch a step closer to regulatory approval.
But there’s another story here, one that isn’t yet being reported. Why did the FDA reviewer reverse himself just a day after such a big stink was made about how potentially unsafe the patch was:
But FDA reviewer Dr. Robert Levin found the patch produces troubling side effects too often to be considered safe. His findings were in briefing documents released by the agency on Thursday in advance of a public meeting on the drug.
To any outsider, like myself, this looks just like a phone call was made to Dr. Levin, and he was ordered or convinced to change his opinion. But why? What made this FDA researcher/reviewer change his mind overnight??
However, the panel of independent experts voted to recommend to the Food and Drug Administration that the patch’s label encourage its use only as an alternative treatment for children with ADHD — in effect, saying doctors should prescribe it if taking pills is too difficult for a child.
The unanimous vote by the FDA’s Psychopharmacologic Drugs Advisory Committee, saying the patch was acceptably safe, came after a formerly critical FDA reviewer reversed his opinion about the drug.
The agency will now decide whether to approve the patch. It usually follows the advice of its advisory committees but is not required to.