In recent years, the Department of Justice, the FDA and the FBI have stepped up enforcement of the Food Drug and Cosmetic Act’s (FDCA) drug importation, distribution and misbranding requirements particularly with respect to high-priced and difficult-to-obtain drugs used in cancer treatment. Recently, these efforts suffered an unexpected setback in the Sixth Circuit following the United States’ decision to abandon its prosecution against an East Tennessee Oncologist and his wife.
This case began when Dr. Sen, and his wife, Posey Sen, were solicited by a mail order pharmacy, which, unbeknownst to them, was importing oncology drugs from Canada and then reselling them without disclosing their true origin. Dr. Sen’s wife, who was also the practice manager, unknowingly purchased these improperly imported oncology drugs from the pharmacy. Following the purchase, prosecutors charged both Dr. Sen and his wife in a 110-count indictment with violating Section 331(a) of the FDCA, alleging that the drugs were not approved for use by the FDA and were considered “misbranded,” as they were not made at facilities registered by the FDA and their packaging contained foreign languages, among other things. The government’s case rested on the attenuated theory that the FDCA criminalized the mere ordering of these drugs by Dr. Sen’s wife, despite the fact she did not know, and had no reason to believe, that the drugs were being imported improperly. Even more troubling, the government took the position that Dr. Sen was liable simply because his wife – an employee of his practice – ordered the drugs without the doctor's involvement or knowledge. Prosecutors persisted with these charges despite the fact that Dr. Sen and his wife seemingly qualified for the FDCA Section 333(c) “safe harbor” by trying to do the right thing and immediately informing the government where they received the drugs, surrendering the drugs to an FDA agent, and assisting the FDA with its investigation.
Following trial, both Dr. Sen and his wife were acquitted on the 81 felony counts against them but were convicted of 29 misdemeanor counts that did not require the government to prove that they acted with any knowledge that the drugs were misbranded. The Sens appealed these convictions. Following briefing, the United States decided to abandon the prosecution and filed a motion to vacate the convictions of both Dr. Sen and his wife.
This surprise move may signal a change in the way the Department of Justice will approach misbranding cases brought under the FDCA and has important lessons for doctors, physician practice managers, pharmacists and others:
- Providers need to continue to be vigilant about the sources of their drugs, particular if they are being bought from an Internet-based supplier, or one with which the provider has no history.
- If contacted by the FDA, FBI or other investigating agency, providers should strongly consider engaging counsel. In the Sen case, the Court found that the FDA agent improperly seized certain misbranded drugs. Early involvement of experienced counsel can avoid such issues and ensure that the provider can take advantage of the §333(c) "safe harbor", if applicable.
Providers need to be aware that this area is a focus for investigations and prosecutions by the Department of Justice, the FDA and the FBI and rapidly developing with decisions like Sen and others. For additional information, please contact J.D. Thomas or any member of Waller’s Government Investigations | White Collar Defense team at 615.244.6380 or 800.487.6380.
The opinions expressed in this bulletin are intended for general guidance only. They are not intended as recommendations for specific situations. As always, readers should consult a qualified attorney for specific legal guidance.