The Drug Enforcement Administration (DEA) regulates the registration of manufacturers, distributors, pharmacies, and practitioners authorized to handle prescription drug controlled substances. The revocation of an existing 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), 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, presented by Karla Palmer and Andrew Hull of Hyman, Phelps & McNamara P.C., provides 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.
Andrew J. Hull represents clients on matters related to administrative, civil, and criminal investigations and proceedings conducted by the DOJ, DEA, FDA, and state authorities under the federal Controlled Substances Act (CSA), the Federal Food, Drug, and Cosmetic Act, and related state laws and regulations. He also advises clients on compliance with federal and state laws and regulations related to the manufacturing, distributing, and dispensing of controlled substances and prescription drugs, particularly under the federal CSA and the Drug Supply Chain Security Act.
Prior to joining the firm, Mr. Hull served as the law clerk to the DEA’s Chief Administrative Law Judge (ALJ), John J. Mulrooney, II, a position he was awarded through the DOJ’s Attorney General’s Honors Program. As a law clerk, he co-authored with Judge Mulrooney the first in-depth primer for practitioners and pharmacies involved in administrative proceedings and hearings before the DEA, titled Drug Diversion Administrative Revocation and Application Hearings for Medical and Pharmacy Practitioners: A Primer for Navigating Murky, Drug-Infested Waters.
At law school, Mr. Hull served as the editor-in-chief of his school’s law review, and he is the author of numerous publications.
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.
I found this lesson very educational.
Exhaustive and interesting.
Solid presentation on this one.
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