Acceptance of Responsibility and Remedial Measures
While DEA focus in the last few years has leaned more and more into investigations of pharmaceutical manufacturers and distributors in headline-grabbing (and money-making) civil penalties cases, the traditional role of the registration enforcement divisions of the agency was focused on investigations into doctors and pharmacies who, in the eyes of DEA, were committing acts of diversion or willfully closing their eyes to the abuse of controlled substances in front of them. When DEA wishes to challenge a registrant and revoke her registration, the agency issues an Order to Show Cause (“OTSC”), summoning the registrant to a hearing where the registrant must show DEA why they should be permitted to keep their registration.
During my work at DEA, I saw a material point often missed by registrants called before a DEA administrative law judge: the Show Cause hearing is not the same as a criminal defense hearing. Generally speaking, in an ideal world, a defendant in a criminal proceeding has the benefit of being innocent until proven guilty. With DEA OTSC hearings, the agency has already produced enough evidence internally to summon a registrant before the tribunal to show cause why her registration should not be revoked. A registrant in an OTSC hearing starts from a position of “guilt” and must prove themselves to the agency.
If a registrant may present a valid defense to the factual allegations raised in the DEA OTSC, obviously it behooves the registrant to present all evidence to contradict any and all allegations. Counter-experts and anecdotal evidence of extenuating circumstances can be powerful tools to defend against the Government allegations. But in many circumstances, a registrant defending himself against the allegations from the OTSC is fighting an uphill battle or, worse still, digging their own grave by ignoring the most important factor in the agency’s analysis of whether or not to revoke a registration: acceptance of responsibility and remedial measures.
DEA has repeatedly held that where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for his actions and demonstrate that he will not engage in future misconduct. Thus, under agency law, admitting fault is properly considered by DEA to be an important factor in the public interest determination.
Too often, a registrant spends too much of his resources and his trial time focused on the factual allegations from the OTSC. A defending physician or pharmacy needs to be able to look at the larger picture, to analyze the potential outcomes, and to understand that the agency is not engaging in random and arbitrary enforcement of its regulations. In the event that a registrant has made a mistake, the registrant must be able to own up to the mistake, and to present to the agency evidence of any measures being taken to ensure that the particular type of violation claimed by DEA will not happen in the future.
Remedial measures may take many forms. For practitioners brought before the agency for allegations related to self-abuse of controlled substances, the agency looks very highly upon self-imposed third-party monitoring and drug tests, or mandatory NA or AA meetings. For pharmacies, it may involve submitting new policies related to contacting prescribing physicians to confirm the validity of a prescription, or implementing systems to make sure all prescribing physician DEA registration numbers are valid and updated.
Registrants facing corresponding criminal cases in relation to their prescribing practices must walk a very thin line between accepting responsibility and admitting liability – anything testified to in a DEA hearing can theoretically be used against a registrant at a subsequent criminal proceeding. However, it may be argued that the execution of remedial measures is, in itself, an acceptance of responsibility, as a registrant shows that while his understanding of the regulation may have been flawed, he accepts the DEA interpretation and is implementing measures to get in line with the law of the land.
In the event of an OTSC, acceptance of responsibility and implementation of remedial measures are the most important steps towards maintaining or reinstating your DEA registration. However, as always, DEA is not quite straightforward with the details of what it looks for in terms of implementation of such measures.
Mr. Novak is a former attorney for the United States Department of Justice Drug Enforcement Administration. Jonathan is now working nationwide representing public entities, including counties, cities, and Native American tribes, in litigation against manufacturers and distributors of opioid controlled substances, as well as providing education and legal guidance on state and federal controlled substance regulations. If you have any questions or concerns regarding regulatory compliance, state or federal enforcement action on your controlled substance or pharmacy registration, or if you represent a public entity interested in learning more about potential litigation against opioid manufacturers and distributors, please contract Jonathan directly ([email protected]).
This blog is for informational purposes only and meant to provide general insight and commentary; it is not meant to convey specific legal advice. By using this blog site you understand that there is no attorney client relationship of any kind. The information contained in this blog is opinion based and should not be used as a substitute for skilled legal advice from a licensed professional attorney in your state.