We published a version of this post several years back (see here), but recent updates to the law and trends in DEA enforcement merit a refresher. The stakes are high when a DEA-registered practitioner, pharmacy, distributor, manufacturer, or other registrant receives an Order to Show Cause (or OSC) from DEA. OSCs often appear without warning and can throw a registrant into a flurry of uncertainty and risk of losing a registration necessary to conduct business. Failing to respond in a timely or appropriate manner may also result in a waiver of your rights.
If you are in receipt of an Order to Show Cause from DEA and lost as to what it means or what to do, read this short primer to help guide you in making necessary and correct decisions in a prompt manner to protect your business and preserve your rights.
What Is an Order to Show Cause?
An Order to Show Cause is DEA’s official initiation of an administrative proceeding to revoke or suspend an existing DEA registration or deny an application for a DEA registration. By law, DEA must provide you with notice and an opportunity for a hearing before it can take away your registration (or deny your application), so DEA will issue an Order to Show Cause, which explains the legal grounds for revoking or denying a registration and informs you of your right to challenge DEA’s decision.
What Are Your Options When You Receive an Order to Show Cause?
You have several options. The first is to request a hearing before one of DEA’s administrative law judges (ALJs). To preserve your right to a hearing, you must file a request for a hearing with DEA’s Office of Administrative Law Judges within thirty (30) days of service of the Order to Show Cause. A second option is to waive your right to a hearing and simultaneously file a written position statement, again within thirty (30) days of service of the Order to Show Cause. A third option is to ignore the Order to Show Cause, in which case DEA will request a final order based only on DEA’s evidence. Which option is right for you is a decision that is best made after consulting with experienced counsel.
If you decide to request a hearing, DEA’s revised hearing regulations require that you simultaneously file an Answer to the Order to Show Cause. The Answer must address each factual allegation in the OSC and specifically admit, deny, or state that the party does not have and is unable to obtain sufficient information to admit or deny the allegation. It is not enough to file a timely request for a hearing; failure to simultaneously file an Answer may result in default, and DEA will deem each factual allegation not denied to be admitted against you.
Failure to file a request for hearing and answer in a timely manner (i.e., 30 days from service) may result in a waiver of the right to a hearing and a default, absent a timely request for an excuse demonstrating good cause.
What Happens If You Request a Hearing?
A timely request for a hearing places your case on the docket of one of the ALJs. The ALJ will issue an order for prehearing statements and schedule a prehearing conference. At the prehearing conference, the ALJ will set a date and location for the hearing.
The hearing closely resembles a trial, but the ALJ (rather than a jury) is the trier of fact. Both the government (represented by DEA counsel) and you will have an opportunity to present your case through witness testimony and record evidence. Hearings can range from half a day to several weeks, depending on the complexity of the case. After the hearing, both parties may submit post-hearing briefs, and the ALJ will issue a recommended decision. The parties may file exceptions to the decision if they believe the ALJ made a factual or legal error in the decision. The recommended decision is submitted to the DEA Administrator who reviews the decision, rules on the exceptions, and issues a final order regarding your registration, either adopting or rejecting the ALJ’s recommended decision.
Not all cases end up going to hearing, however, as DEA is sometimes willing to consider a settlement resolution.
What Happens If You Waive Your Right to a Hearing?
If you choose to forgo a hearing, the government will forward your case with its evidence (along with any timely submitted position statement) to the Administrator. The Administrator will then issue a final order based on the review of the evidence and written statements provided. Remember that all factual allegations in the Order to Show Cause that have not been denied will be admitted against you.
What Is an Immediate Suspension Order?
An Immediate Suspension Order is the exception to the rule that DEA will not revoke or suspend an existing DEA registration prior to a hearing. An Immediate Suspension Order allows DEA to suspend your registration upon a determination that there is an “imminent danger to the public health and safety.” An Immediate Suspension Order is served along with an Order to Show Cause, allowing you to challenge DEA’s determination that your registration should be revoked, but it takes away your ability to handle controlled substances while your case is pending. As a result, an Immediate Suspension Order can significantly (and immediately) affect your ability to practice medicine or operate your business.
What Is a Corrective Action Plan?
Recipients of an Order to Show Cause (except those also receiving an Immediate Suspension Order) are permitted to submit a Corrective Action Plan. A Corrective Action Plan provides an opportunity for the registrant to demonstrate remedial actions contemplated or taken, and requests DEA to discontinue the Order to Show Cause proceedings. What should be discussed or admitted in a Corrective Action Plan is a decision that likely should be made after seeking advice from an experienced attorney.
Are You Allowed to Have an Attorney Represent You?
You are permitted to proceed on your own (i.e., pro se) or to have an attorney represent you. Because of the complex nature of these proceedings and the stakes involved, representation by a law firm experienced in handling DEA hearings may be a necessity.
What Resources Are Available?
DEA’s Office of Administrative Law Judges has a website containing forms and links to a variety of helpful legal resources, including instructions on filing documents. We also regularly blog on DEA administrative cases and procedures (see here), and our HPM attorneys have authored articles (see here and here) on the DEA hearing process. Our experienced HPM attorneys stand ready to defend you or company when you face an Order to Show Cause.
