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Last Updated on: 2nd August 2023, 05:43 pm
While working with controlled substances, you have specific legal obligations that include exercising appropriate measures to keep controlled substances out of the hands of those who might abuse them. If you violate those obligations, you may receive what’s called a show cause order from the Agency of Drug Enforcement. This article will discuss the specifics behind what a show cause order is, what it means for you and your practice or business and the options you have in the event you should receive one.
What Is a Show Cause Order?
When you receive a show cause order, it means you have violated the Effective Drug Enforcement Act in some way. Therefore, the order should be taken seriously, and prompt action must be taken because the order can jeopardize your ability to continue your practice or maintain business operations.
A show cause order is an official administrative proceeding from the United States Drug Enforcement Agency initiated to suspend an existing registration or revoke an application for a registration. By law, when you’re served with a show cause order, the DEA must provide legal grounds for revoking your application or registration and provide an opportunity to defend yourself in court in which you can plead your case before they can revoke your registration or application.
Usually, the Drug Enforcement Agency will serve you a show cause order if you:
What Can I Do In My Defense?
When you are served with a show cause order, you have certain rights that are designed to comply with your constitutional right of due process. These rights include:
Exceptions to the Rule
The only way that the DEA can immediately suspend your registration or application before a hearing takes place is if there’s a reasonable belief that allowing you to continue your practice or business would represent an imminent danger to public health or safety.
The Effective Drug Enforcement Act defines “imminent danger to public health or safety” as a risk of death, serious bodily harm or serious drug addiction as a result of either ineffective diversionary measures or a failure to maintain effective controls over who receives controlled substances. In such cases, the DEA will issue you an immediate suspension order along with the show cause order.
If such a determination is made, you will be forbidden from handling controlled substances until your case reaches a decision. This means that you will be legally unable to continue to prescribe controlled substances. The decision of the hearing judge is considered final, and appropriate action will be taken if it is deemed necessary.
Contact Us for a Consultation
The Spodek Law Group can represent you in your hearing. Our experienced attorneys have years of experience in handling cases involving show cause orders. Due to the complexities of the law, we strongly suggest that you hire an experienced lawyer to assist you in your case. You may contact our office with any questions you may have or if you wish to schedule a consultation.
The DEA may issue an Order to Show Cause to a provider for a number of reasons, including:
If you have received an Order to Show Cause, you will have an opportunity to respond in writing within 30 days. You will also be given the opportunity to request a hearing on the matter. It is important that you take advantage of this opportunity and hire an experienced DEA registration attorney who can help you prepare your response and represent you at the hearing. If you do not respond within 30 days, your registration will be automatically suspended or revoked. An experienced DEA registration attorney can help ensure that your response is timely filed and that it includes all relevant information that may be helpful in protecting your registration. If a hearing is requested, it will be held before an Administrative Law Judge (ALJ) within 90 days after the date on which the notice of hearing was mailed. The ALJ will issue a recommended decision after considering all evidence presented at the hearing, which will then be forwarded to the Administrator for final review and action. An experienced DEA registration attorney can help ensure that all evidence is properly presented at the hearing so that your interests are protected throughout this process.
If you have received an Order to Show Cause from the DEA, you need to take action quickly. An experienced DEA registration attorney can help you determine how to respond and protect your interests throughout the process.
The Show Cause Order will also provide the provider with an opportunity to explain why the DEA’s decision is incorrect. The provider will have a specific amount of time to respond to the Show Cause Order, and it is important that this response be submitted in a timely manner.
If the provider does not respond to the Show Cause Order within the specified time period, or if their response is deemed unsatisfactory by the DEA, then their registration will be suspended or revoked. If a registration application has been denied, then it cannot be resubmitted for at least one year.
A provider who has had their registration suspended or revoked may appeal this decision by filing a petition with the DEA’s Administrative Law Judge (ALJ). The ALJ will review all of the evidence and testimony related to the case and make a determination as to whether or not there was sufficient cause for the DEA’s actions. If it is determined that there was not sufficient cause for these actions, then the ALJ may order that the provider’s registration be reinstated.
If you have received a Show Cause Order from the DEA, or if you are facing any other type of disciplinary action from the DEA, it is important that you seek legal assistance as soon as possible. The attorneys at Spodek Law Group have extensive experience representing healthcare providers in administrative matters before the DEA and other federal agencies, and we can help you to understand your rights and options.
If a person does not agree with the ALJ’s decision, they can file an appeal with the DEA Administrator. If the Administrator does not agree with the ALJ’s decision, they can file an appeal with the U.S. Court of Appeals for the District of Columbia Circuit.
The administrative hearing process is complicated and requires a thorough understanding of DEA regulations and procedures. An experienced attorney can help you navigate this process and ensure that your rights are protected throughout every step of your case.
What Are Some Possible Outcomes of an Administrative Hearing?
If you have been served with an Order to Show Cause, it is important to understand that there are several possible outcomes to your case:
The outcome of your case will depend on many factors, including whether you have a previous history of disciplinary actions, whether there is evidence that you violated federal law or regulations, and whether there are any extenuating circumstances that contributed to any violations that occurred. A skilled attorney can help you develop a strong defense strategy based on these factors and work toward protecting your registration status during administrative hearings and appeals processes.
What Are Some Possible Defenses to an Order to Show Cause?
If you have been served with an Order to Show Cause, it is important to understand that there are several possible defenses that may be available to you. Some of the most common defenses include:
The DEA does not have the authority to take action against your registration; The evidence presented by the DEA is insufficient; The evidence presented by the DEA is inaccurate or false; You did not violate any federal laws or regulations; You did not violate any state laws or regulations; You did not violate any terms of your registration; and/or There are extenuating circumstances that contributed to any violations that occurred.
The best defense strategy for your case will depend on many factors, including the specific facts and circumstances of your case, whether you have a previous history of disciplinary actions, and whether there is evidence that you violated federal law or regulations. A skilled attorney can help you evaluate all of these factors and develop a strong defense strategy based on your unique situation.
What Are Some Possible Penalties for Violating Federal Drug Laws?
If you are convicted of violating federal drug laws, you may face a variety of penalties, including:
Imprisonment; Fines; Probation; and/or The loss of your DEA registration.
The specific penalties that you may face will depend on the specific facts and circumstances of your case, the severity of the offense, and whether you have a previous history of disciplinary actions. A skilled attorney can help you understand all of the potential penalties that you may face and work toward protecting your rights throughout every step of your case.
For physicians, pharmacists, and other registrants authorized to handle controlled substances, receiving a DEA Order to Show Cause can be a terrifying experience. These formal notices threaten exclusion from federal programs and revocation of DEA registrations that allow prescribing medications and dispensing narcotics.
Losing this livelihood without a fight is not an option. By understanding the show cause process and enlisting experienced counsel, you can mount an effective defense against DEA allegations of misconduct. This guide covers:
Knowing what to expect and formulating the right legal strategy can help quash DEA action or at least mitigate the consequences. Don’t delay engaging experienced counsel.
DEA focuses show cause orders on registrants suspected of:
These arise from audits, informant tips, patient overdoses, raids finding violated records, and data analysis of prescription histories.
These formal notices outline several key elements:
Any vagueness should immediately be challenged to allow mounting a proper rebuttal.
While show cause proceedings vary case-by-case, they tend to adhere to the following phases:
Investigation – Surveillance, data analysis, audits and informant tips help DEA build allegations. Targets unaware.
Pre-hearing discovery – DEA provides evidence backing charges. Defense counsel reviews and prepares.
Written response – Within 30 days, respondent files a detailed written reply arguing why registration should remain intact.
Prehearing conferences – Continued negotiations and evidence sharing with potential for settlement.
Administrative hearing – Before a DEA judge, prosecutors present charges and defense rebuts allegations.
Ruling – Judge decides whether revocation warranted and registration expires. Sanctions like fines also possible.
Appeals – Administrative review board can affirm or overturn rulings. Federal court appeals also possible.
This complex litigation process requires experienced counsel guiding each stage.
A forceful yet nuanced response is required to defeat show cause orders. Smart legal strategies include:
In responding, balance mounting an aggressive defense while also expressing willingness to resolve DEA concerns constructively.
Given the complexities of DEA enforcement machinery, retaining an experienced administrative law and controlled substances attorney is essential. Look for subject matter expertise from among:
Carefully vet credentials like specific controlled substances case experience, DEA hearing record, and reputation with agents and prosecutors. This is no place for amateurs.
REACTING hastily or naively to show cause orders often backfires, as does delaying engagement of counsel.Specific errors to sidestep include:
Let experienced lawyers interface with DEA directly while you remain in strict compliance moving forward.
Being slapped with a DEA show cause order threatens everything you have built through years of medical training and practice. But all is not necessarily lost. With a vigorous evidence-based rebuttal argument and negotiations steered by knowledgeable counsel, suspensions can often be avoided or limited.
Wasting time is your enemy, however. Enlist experienced legal firepower immediately to improve the odds of preserving your reputation and registration. But also follow counsel’s advice meticulously to avoid making the situation worse through hasty missteps. Your livelihood deserves a full-throated yet disciplined defense against any DEA overreach.
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