Ruling Undercuts FDA’s Authority to Regulate Compounding
FDA’s crack down on compounding has apparently been dealt a setback according to this FDA News Story describing a U.S. District Court opinion. I had previously discussed FDA’s recent crackdown on national compounders, which FDA claimed were behaving more like drug manufacturers than compounders, risking patient safety. Let’s have a brief look at the lawsuit and opinion itself (Decision).
A group of compounding pharmacists joined forces to sue FDA in 2004. They sought summary judgment relief from FDA in five general areas: the practice of compounding itself, FDA inspections of compounding pharmacists, compounding from bulk ingredients for non-food animals, FDA’s compliance policy guideline 608.400 (relating to compounding for non-food animals), and injunctions against FDA.
Compounding itself:
Plaintiffs claim that compounded drugs are not “new drugs” under the United States Code. FDA disagrees. The Court sided with the Plaintiffs, granting summary judgment, finding that FDAMA (1997) implicitly exempts compounded drugs from the new-drug definitions. However, the Court upheld FDA restrictions that limit compounding to “compounds which are made in reasonable quantities upon receipt of a valid prescription for an individual patient from a valid prescriber. Drugs that are compounded in large quantities before a prescription is received from a doctor do not fall with the narrow exemption this Court finds exists.”
Inspections:
Plaintiffs contended that they are exempt from inspections, beyond FDA’s general and limited inspection authority, specifically from “enhanced inspections” that include inspections of records. FDA argued that they were entitled to the enhanced inspections. The Court sided with the Plaintiffs, finding that since the Plaintiffs themselves met the inspection exemption requirements of USC 374(a)(1), they were exempt from inspections. Note that the Court was careful to make this judgment applicable only to the Plaintiffs in this case, as they had demonstrated their exemption status.
Compounding from Bulk for Non-food Animals and FDA’s Policy Guideline:
The Plaintiffs argued that nothing in the law prevented them from compounding drugs for non-food animals. FDA argued that such drugs were new drugs that were unsafe, adulterated and misbranded. The Court again sided with the Plaintiff’s, finding that pharmacies may compound for non-food animals using legal bulk drug. As far as the policy guideline on non-food animal compounding, the Court agreed with FDA that its policy guideline doesn’t violate the Adminstrative Procedure Act’s requirement for notice and comment, since it doesn’t contain new substantive rules. However, the Court further found that FDA would not be premitted to enforce the portion of its policy guideline and notice which conflict with the Court’s ruling on compounding (above).
Injunctions:
Plaintiffs sought injunctions against FDA that would prevent FDA from declaring that: compounded drugs were new drugs,engaging in enhanced inspections, enforcing its compliance policy guideline,prohibiting plaintiffs and other compounding pharmacists from receiving bulk ingredients, and bringing actions against Plaintiffs for refusing to allow FDA to conduct enhanced inspections. The Court denied these injunction requests without prejudice, opening the door for future injunctions to be granted if re-urged later.
Putting it all together, I can see how this Court ruling can be construed as a victory for compounding pharmacists. It was clearly a victory for the Plaintiffs who swept the Court’s decisions, save for the injunctive relief sought. And it reinforced legal support for the practice of compounding per se. However, FDA’s recent crackdown on compounding pharmacists and their threat to go after other compounding pharmacists are not based on arguments the Texas Court defeated. Rather, FDA is claiming that these compounders violated laws regulating new drugs and that they are not exempted by FDAMA. Specifically, FDA is going after compounding pharmacists that it believes are acting like manufacturers of drugs, making drugs in advance of receiving a valid prescription. The Court in the Texas case was careful to note that the Plaintiffs in this case were found not to have violated the FDAMA exemptions for compounding pharmacists, leaving the door open for rulings against compounders that do violate these exemptions. In a nutshell, this ruling leaves allows FDA to shutter the operations of manufacturers that disguise themselves as compounding pharmacists, while allowing genuine compounding pharmacists to operate legally. Sounds like a win-win to me.
