The Drug Enforcement Administration (DEA) regulates manufacturers, distributors, pharmacies, and practitioners authorized to handle prescription drug controlled substances. The revocation of an existing DEA registration, or the denial of an application for registration, can significantly impact the livelihood or business of an affected party. Under the Controlled Substances Act (CSA) and DEA’s implementing regulations, such parties are entitled to a full administrative hearing before DEA’s administrative law judges.
Revocation and denial hearings are complex and require detailed knowledge of DEA hearing procedures, as well as agency interpretation of the CSA and the DEA’s implementing regulations. This course, taught by Karla Palmer of Hyman, Phelps & McNamara P.C., will present a general background of the Controlled Substances Act and its implementing regulations, and recent legislation affecting DEA registrants such as the SUPPORT Act, enacted in late 2018. The program will also provide an overview of the hearing process, an introduction to the statutory basis for revocation or denial, and a discussion of recent “hot” issues in DEA administrative decisions. Finally, the presenter will address recent DEA administrative actions, with a focus on the ongoing opioid crisis and the DEA’s increased focus on the diversion of opioid medications.
Karla L. Palmer focuses on DEA and FDA enforcement and litigation matters, with particular emphasis on Controlled Substances Act (CSA) issues. Ms. Palmer advises clients throughout the supply chain, from manufacturers and distributors to pharmacies and doctors on a range of issues including government inspections and investigations, warning letters, consent decrees, and administrative and federal proceedings.
Ms. Palmer also advises compounding pharmacies and outsourcing facilities on all aspects of the Drug Quality and Security Act, and has closely followed developments in the law prior to and since its enactment in late 2013.
Over the course of her career, Ms. Palmer has been involved in all aspects of commercial litigation. She has served as trial counsel in federal, state, and administrative courts in the District of Columbia, Florida, Illinois, Maryland, New York, Nevada, Pennsylvania, Kansas, Virginia, and before the Court of Federal Claims, the U.S. Tax Court, and Federal Energy Regulatory Commission (FERC). She also has significant arbitration and mediation experience.
Before joining Hyman, Phelps & McNamara in 2010, Ms. Palmer was a partner at a large international law firm where she was head of the Washington, D.C. trial department and co-partner-in-charge of its national recruiting program. Following law school, Ms. Palmer clerked for the Honorable Claude M. Hilton, former Chief Judge of the U.S. District Court for the Eastern District of Virginia, Alexandria Division. She has served as both lead and local counsel in the Eastern District of Virginia.
While in law school, Ms. Palmer was an associate editor of The University of Richmond Law Review, a member of the McNeill Law Honor Society, and a legal writing teaching assistant.
Ms. Palmer is an immediate past member of the Board of Directors of the Law School Alumni Association at the University of Richmond, and is a former board member of Chattering Children, a nonprofit that provides speech and language education, therapy, and services to hearing impaired children throughout the Washington, D.C. area.
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This was a great course.
I had no background in the subject but was still able to follow along, due to the clarity of the presentation. Thank you.
Good general overview with useful details