In a recent press release, the United States Attorney’s Office for the Northern District of New York announced that a Poughkeepsie physician and his wife were sentenced for a misdemeanor for ordering and administering to patients, drugs that were not approved by the FDA and were obtained from foreign sources. In addition to the criminal conviction, they agreed to pay $500,000 to the federal government for alleged violations of the False Claims Act. The press release can be found here.
The FDA strictly enforced its regulations and guidelines related to the administering of non-approved drugs. According to an FDA publication in November 2017, a primary concern is that drugs marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling. Moreover, it warns that physicians cannot assume that all marketed drugs have been found by the FDA to be safe and effective. The FDA is also concerned that the labeling on these drugs may not contain information required by law. Lastly, physicians should be aware that the Food, Drug and Cosmetic Act strictly regulates the importation of drugs from non-approved foreign sources.
Health care providers should be mindful of the FDA and other agency regulations when prescribing or administering non-traditional drugs. Where appropriate, providers should seek the guidance of health care legal counsel as well. If you have any questions about this or any other legal matter, please email me at email@example.com.