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.
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