Interactions with the Drug Enforcement Administration (“DEA”), whether criminal or civil in nature, can have serious ramifications on the careers and livelihoods of doctors, dentists, veterinarians, pharmacies, wholesale distributors, and other health care professionals in possession of a DEA registration.
This is why it’s imperative to obtain an attorney who specializes in defending DEA administrative action and order to show cause proceedings. But what are some of the key processes the DEA uses to suspend or revoke a DEA registration? And what you can do about protecting or reobtaining yours?
An Order to Show Cause is the DEA’s initiation of an administrative proceeding to revoke or suspend a DEA registration. To comply with the procedural due process, the DEA must provide you with notice of their intent to revoke or suspend your registration, and an opportunity for a hearing. So the DEA will issue an Order to Show Cause, which explains their reason for revoking your registration and informs you of your right to challenge that decision. You will likely receive this in the form of a certified letter to your registered address.
From this point, there are several options available to DEA registrants.
First, you may 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 30 days of service of the Order to Show Cause.
Second, you may waive your right to a hearing and simultaneously file a written statement of why your registration should not be revoked, again within 30 days of service of the Order to Show Cause.
Finally, 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, usually resulting in a revocation of your DEA registration.
The option that is best for you is a decision that is best made after consulting with experienced DEA order to show cause attorney. Due to the requirements for filing an appropriate response, it is imperative that you retain legal counsel as soon as possible.
Prior to going to a hearing, the government will file a pre-hearing statement. This statement will detail the evidence against you and the DEA’s proposed witness testimony. Your attorney must respond with a highly detailed pre-hearing statement. Often, general criminal law attorneys who are not experienced in this area overlook this requirement, and that can severely damage your case going forward.
If evidence is not first presented in your pre-hearing statement, the judge will exclude it from the hearing. After statements are exchanged, your counsel will likely file motions seeking various forms of relief. A show cause hearing will take place either near your practice or at the DEA office of administrative law judge.
The hearing will be presided over by a DEA administrative law judge who has been appointed by the DEA but operates independently to hear cases. In our experience, these judges are fair but have little patience for attorneys who do not take the time to understand the specific rules of litigating a DEA order to show cause hearing.
The hearing will proceed much like a trial with an opening statement, the DEA will present its case, and your counsel will have an opportunity to call witnesses. The judge will rule on objections and procedural issues.
At the conclusion of the hearing, the judge will issue a proposal for decision. This proposal is non-binding on the DEA, meaning that it is not a final order.
Your counsel will file objections if the decision is adverse. After objections are filed, the case will be reviewed by the DEA administrator. This will take a long time; the administrator has typically been incredibly slow in deciding these cases; in some of the cases we at Chapman Law Group have handled, the administrator has taken up to two years.
This issue was the subject of a Department of Justice report that found a significant delay in administrative decisions. Unfortunately, short of filing an injunction in federal court, there is no way to speed up this process. Once the DEA administrator enters a final decision into the Federal Register, the decision will typically be effective within 30 days. Any appeal of this decision would be to a federal court.
In recent years, the DEA has been utilizing a variety of tools to combat the opioid epidemic. One in particular is “strong-arming” registrants to sign a DEA Form-104 Voluntary Surrender of their DEA registration.
Often, the DEA utilizes threats of licensing and criminal actions against the registrant and false promises of reapplication. In 2011, the DEA enacted a “final rule” under 21 C.F.R. § 1301.52, a surrender effectively immediately upon receipt by any DEA agent.
Ordinarily, registrants must re-apply for a DEA registration upon which the DEA will issue an order to show cause requiring the registrant to plead their case after a lengthy delay before any hope of reobtaining their DEA registration.
An effective alternative available to registrants is to appeal the voluntary surrender in federal court by seeking injunctive relief in the form of a preliminary injunction or temporary restraining order.
The healthcare criminal law attorneys at Chapman Law Group have extensive experience in DEA Orders to Show Cause, as well as DEA investigations, DEA registration revocation or denial, drug diversion and drug trafficking, and unlawful controlled substance dispensing.
We have four national DEA matters and healthcare defense law office locations to serve you:
Contact us today.
"*" indicates required fields
Our criminal law and healthcare fraud lawyers look back to a complex criminal case that shows how, even in the worst of situations, the right things can happen for a healthcare practitioner being dragged through a criminal maelstrom.
Chapman Law Group’s Ronald W. Chapman Sr. and Juan Santos hosted a CLE session on DOH, DEA, Medicaid at the Florida Pharmacy Association Law & Regulatory Conference in Sarasota.
Our national DEA attorneys are dedicated to defending prescribers and dispensers against DEA investigations, registration applications and denials, audits and raids. Here’s what healthcare providers should know about the DEA process, from our perspective.
The CDC Guidelines for prescribing controlled substances like opioids, and the DEA/DOJ investigations that follow, are putting physicians and their pain patients in a regulatory crunch.
If a physician is excluded from Medicare/Medicaid because he/she accepted a kickback, does this mean he/she could be denied DEA registration in the future? Not necessarily.
Michigan OFFICE
1441 W Long Lake Road
Suite 310
Troy, MI 48098
T. 248.644.6326
F. 248.644.6324
CALIFORNIA OFFICE
5250 Lankershim Blvd.
Ste. 500
North Hollywood, CA 91601
T. (818) 287-0576
FLORIDA OFFICES
6841 Energy Court
Suite 120
Sarasota, FL 34240
T. 941.893.3449
701 Waterford Way
Suite 340
Miami, FL 33126
T. 305.712.7177
Practice Areas
Attorneys
© CHAPMAN LAW GROUP. ALL RIGHTS RESERVED
