RULING UNDERCUTS FDA'S AUTHORITY TO REGULATE COMPOUNDING
The FDA has been denied two of its central strategies in regulating compounded drugs by a federal court decision that could undermine future agency efforts to regulate this practice, industry sources said.
The U.S. District Court for the Western District of Texas issued its findings Aug. 30 in Medical Center Pharmacy, et al. v. Gonzalez. The judge took the unusual step in late May of issuing a decision from the bench without writing a formal opinion. But while Judge Robert Junell had earlier indicated that he would rule against the FDA, the decision provides plenty of ammunition for compounding proponents to use in fighting agency regulations, industry observers said.
Drug compounding, a practice in which pharmacists manufacture prescription drugs from bulk ingredients, is traditionally done for medical reasons, such as when a patient is allergic to an inactive ingredient in the commercially manufactured drug.
In this ruling, the court went beyond its earlier finding that the FDA does not have the authority to classify compounded products as new drugs to add that the agency cannot prohibit pharmacists from using bulk ingredients to create customized medications. While the agency has never prohibited the use of bulk ingredients for human prescriptions, it had done so for animal products. Compounding proponents believed that the FDA would soon try to apply this policy to human drugs. Fighting this practice was the pharmacists' effort to pre-emptively stop the agency from applying this approach to human drugs, Steven Hotze, one of the plaintiffs in the case, said.
Making pharmacists go through the regulatory steps required for new drugs and prohibiting the use of bulk materials are two of the strategies the FDA uses to curb compounding, plaintiff's attorney Terry Scarborough of Hance, Scarborough, Wright said. The decision "flies in the face of the position taken by the FDA across the board," he said.
The decision is the first of its kind and, while not precedent for other circuits, will be persuasive, Scarborough said. The case is "the snowball that starts the avalanche."