Martha M. Rumore, PharmD, JD, MS, LLM, FAPhA is Of Counsel at Health Law Alliance and a registered U.S. Patent Attorney

Frequently Asked Questions

Health Law Alliance is pleased to announce that a lawsuit it filed on behalf of a Florida community pharmacy in Tampa federal court has resulted in the immediate lifting of a suspension of the pharmacy’s registration to dispense controlled substances, and termination of all further proceedings against the pharmacy in the DEA’s administrative tribunal. This outcome restores the pharmacy’s ability to dispense all controlled substances without restriction and ensures continuity of care for the patients it serves.

This significant win represents the culmination of our firm’s efforts over several months to convince the DEA that the suspension lacked legal justification. From the outset, Health Law Alliance vigorously challenged the DEA’s issuance of the Immediate Suspension Order (“ISO”) as erroneous because it had failed to consider the pharmacy’s maintenance of effective controls against diversion, including extensive due diligence documentation of “red flag” resolution prior to the dispensing of controlled substances.  

TAKING THE FIGHT TO FEDERAL COURT

The DEA, however, attempted to avoid our arguments, claiming simply that the Agency disagreed with our position. The DEA’s administrative tribunal is the quintessential example of “home court advantage:” the courtroom is located in DEA’s headquarters and the presiding judge is a DEA employee. Although we have beaten the DEA resoundingly in that courtroom before, the DEA’s presiding administrative law judge suddenly resigned following the nomination of Terrance Cole by President Donald J. Trump.

The DEA’s administrative tribunal is the quintessential example of “home court advantage.”

Hence, we had no choice but to take the fight to federal court, where we filed an emergency complaint against the Agency and its Administrator, Terrance Cole. After extensive legal advocacy and a demonstration of our ability to back it up, justice ultimately prevailed. On the same day the federal court was scheduled to hold a hearing on Health Law Alliance’s emergency complaint, the DEA reversed course and agreed to lift the ISO against our client. In addition, the DEA agreed that all further proceedings pending pursuant to an Order to Show Cause (“OTSC”) against our client’s registration would be dismissed.

HOLDING THE DEA ACCOUNTABLE FOR OVERREACH

Health Law Alliance’s lawsuit against the DEA successfully restored our client’s ability to service the needs of patients, including with respect to the dispensing of controlled substances. It also held the DEA accountable for an improvidently issued ISO against a pharmacy that had not done what the DEA alleged. Although the DEA’s former administrator had signed the ISO, ultimately the DEA and its current administrator were held responsible and relented once Health Law Alliance filed suit.

This case highlights the critical importance of safeguarding due process for pharmacies and other healthcare providers. Health Law Alliance is proud to have secured a just outcome that not only vindicated its client’s rights but also reinforced the firm’s unwavering commitment to protecting its clients from government overreach.

Health Law Alliance continues to stand at the forefront of defending pharmacies, healthcare providers, and healthcare organizations nationwide against improper government enforcement actions.

Health Law Alliance continues to stand at the forefront of defending pharmacies, healthcare providers, and healthcare organizations nationwide against improper government enforcement actions. With deep experience in government investigations and enforcement matters, combined with a proven track record of litigating complex civil and criminal matters in federal court, the firm has established itself as a trusted and leading advocate for healthcare providers.

About Health Law Alliance

Health Law Alliance is a national healthcare law firm dedicated to representing healthcare providers and healthcare businesses in high-stakes regulatory, enforcement, criminal, and civil matters. The firm’s seasoned healthcare defense attorneys bring extensive experience in both litigation and administrative proceedings, consistently achieving successful outcomes in cases involving some of the most challenging issues facing the healthcare sector.  

Contact us today to schedule a free consultation.

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