The Florida Board of Pharmacy thoroughly investigated and resolved this matter to its satisfaction, but the incident prompted FDA to conduct multiple inspections of Franck’s facilities.
Subsequent to one of the inspections, FDA issued a Form FDA 483 citing various observations primarily involving quality assurance and training issues. None of the observations identified compounding from bulk ingredients as a concern. Franck’s responded to the Form 483 by arguing that, among other things, FDA’s observations involve the practice of pharmacy, over which the Florida Board of Pharmacy has jurisdiction, and that Franck’s was not subject to FDA’s authority because it is not a drug manufacturer. Without further discussion, FDA filed a lawsuit against Franck’s, arguing that Franck’s was engaged in the illegal manufacturing and distribution of animal drugs in violation of the Federal Food, Drug, and Cosmetic Act (“FD&C Act” or “Act”).
Arguments Before the Eleventh Circuit
- The authors of this article submitted an amicus curiae brief in the case on behalf of former FDA officials in support of the Defendants-Appellees, Franck’s Lab, Inc., et al., for affirmance of the district court’s decision.
- Franck’s expert witnesses included Sheldon T. Bradshaw, who is a partner and Co-Chair of the Food and Drug Practice at Hunton & Williams LLP, and was the former Chief Counsel of the FDA. Mr. Bradshaw is one of the former FDA officials that filed an amicus curiae brief and is represented by the authors of this article in the appeal of the Franck’s Lab case pending before the Eleventh Circuit.