Judge mulls FDA control over compounded drugs

MIDLAND, TEXAS — The Food and Drug Administration's (FDA) regulatory authority over compounded veterinary medicines hinges on a ruling by a judge who's already hinted at limiting the agency's control in the human sector.

The Food and Drug Administration's (FDA) regulatory authority over compounded veterinary medicines hinges on a ruling by a judge who's already hinted at limiting the agency's control in the human sector.

U.S. District Court Judge Robert Junell's written decision regarding compounded animal drugs was expected soon after he noted from the bench in May that such drugs for human use are not subject to FDA approval. Compounds fail to qualify as new, unapproved drugs in human medicine, but more study was needed for the case's animal drug element, he contended. In July, Junell invited another round of briefing on the animal drug issue before handing down a final verdict, not released by presstime.

The lawsuit, filed by 10 pharmacists, contests FDA's position that it has carte blanche under the Food Drug and Cosmetic Act to enter and inspect compound pharmacies, which are regulated by state pharmacy boards. It also challenges FDA's requirements that compound pharmacies sign the agency's Compliance Policy Guide before participating in trade shows, court documents show.

While conflict between FDA and compounders has ensued for years, the debate came to a head in 2004, when the agency issued letters to state pharmacy boards that all compounding from bulk substances was subject to regulatory authority and inspection. While the struggle has since fizzled, FDA maintains that compounded drugs create new medicines to be policed for safety and efficacy. For now, FDA employs what it calls enforcement discretion to determine when to act against a compounding pharmacy and when to look the other way.

"Clearly, FDA reads the law much differently than compounding does," says L.D. King, executive director of the International Academy of Compounding Pharmacists. "According to FDA, every compounded medication is an unapproved drug, therefore, it is illegal."

FDA officials refused to comment on the ongoing case but noted a willingness to appeal any unfavorable decision. Dr. Kent McClure, general counsel for the Animal Health Institute, represents pharmaceutical manufacturers and comes out on the side of FDA. So far, the judge has only "shared some thoughts," he says.

"There's nothing to appeal until there's a written order signed by the judge," McClure says. "He's reserving the question of animal drugs and voices some apprehension. It's anybody's guess when the written order will come out. That's where the real meat of this is going to come."