Oxford Pharmaceuticals LLC filed a complaint against Alabama State Board of Pharmacy, its president, vice president, treasurer, a member, and executive secretary, as well as the Food and Drug Administration. The purpose of the lawsuit is to obtain a declaration that the FDA’s May 2019 inspection of the plaintiff does not warrant any disciplinary action.
According to the complaint, the defendants originally filed a lawsuit against the plaintiff claiming the plaintiff violated the Food Drug and Cosmetic Act (FDCA), and sought to have the plaintiff’s Alabama license revoked and assess disciplinary penalties against the plaintiff. However, after the aforementioned 2019 inspection by the FDA, the federal agency determined that Oxford minimally complied with regulations and thus, there was no warranted disciplinary action to be taken against the plaintiff. The complaint alleges that several months after the FDA’s inspection, the defendant inspected the plaintiff’s facility and also found it to be compliant.
However, more than three years later, the defendants have brought the same charges against the plaintiff and has set the hearing for those charges on August 16.
The plaintiff seeks the following for relief: a judgement declaring that the FDA has exclusive rights to enforce the FDCA against the plaintiff, a temporary restraining order and preliminary injunction preventing the defendant from proceeding with the August 16th hearing, and attorney’s fees.
The plaintiff is represented by their personal counsel and Baker Donelson Bearman Caldwell & Berkowitz P.C.
