understood; it was manufacturing unapproved duplicates of FDA-approved drugs and distributing them for a large-scale market without first receiving valid prescriptions for the individual drugs.” During a May 26, 2017, Congressional hearing, Dr. Gottlieb signaled to proponents of loosening compounding restrictions that for there to be changes, Congress would have to “revisit it as a matter of statute.”On June 26, 2017, Dr. Gottlieb issued yet another statement reiterating the “importance of the [DQSA] and overseeing the safety of compounded drugs.” His statement noted that the FDA had conducted more than 400 inspections, including 109 inspections of outsourcing facilities; issued more than 150 warning letters advising compounders of significant violations of federal law; issued more than 50 letters referring inspectional findings to state regulatory agencies; overseen over 125 recalls involving compounded drugs; and worked with the Department of Justice on a number of civil and criminal enforcement actions. He also noted that the FDA has issued 21 draft guidance documents, ten final guidance documents, three proposed rules, a final rule, and a draft memorandum of understanding.Caveat EmptorSelling or administering compounded drugs produced in violation of federal law puts practitioners (and their patients) at serious risk. Given the current enforcement posture of the FDA, the potential rewards available to whistleblowers, and the press’ hunger for sensational news stories, the question isn’t whether, but when, the FDA, medical licensing boards, and the public will find out about unlawful compounding activities. Practitioners should take all precautions to insulate their patients and practices from these activities. When FDA goes after an illegal drug compounder, it can be expected to look for the compounder’s customer list. Practitioners who are purchasing these illegally compounded drugs should immediately stop doing so. And, in light of the government’s vigorous enforcement of anti-fraud rules against rogue drug compounding, practitioners who have done business with these compounders should also talk to their lawyers.Sheldon Bradshaw served as Chief Counsel of the United States Food and Drug Administration from 2005-2007. He currently is a partner in the FDA and Life Sciences Practice Group at King & Spalding.
Sheldon Bradshaw JD email@example.com