In the three years since the Drug Supply Chain Security Act (DSCSA) took effect there have been significant legal and regulatory developments in drug compounding. Learn where compounders, FDA, States, Congress, and pharmaceutical companies stand on the many issues affecting this important, yet challenging, practice. Speakers will cover pressing issues such as the still-unsettled office use compounding debate, FDA’s draft guidance on “essentially copies” of approved drugs, the status of FDA’s draft MOU addressing interstate shipments, and the status of FDA’s “Bulks Lists.” An analysis of what is on the horizon for compounders from a regulatory (FDA and state inspections) and legal (actions for non-compliance) perspective will be provided.
Elizabeth Jungman, Director, Public Health Programs, The Pew Charitable Trusts
Moderated by Karla L. Palmer, Director, Hyman, Phelps & McNamara
- +$100 for non-members
- Includes opportunity to ask questions
Webinar & Recording
- +$100 for non-members
- Recording provides ongoing access
Elizabeth Jungman is director of public health programs at The Pew Charitable Trusts, overseeing initiatives related to antibiotics, drug safety, and health care products. Before joining Pew, she served as a senior health policy adviser with the Senate Committee on Health, Education, Labor, and Pensions, where she played a key role in drafting and negotiating the Food and Drug Administration Safety and Innovation Act of 2012, the FDA provisions in the Pandemic All-Hazards Preparedness Reauthorization Act of 2013, and the Drug Quality and Security Act of 2013. Before moving to the Hill, Jungman was in private legal practice, where she counseled clients on a broad range of FDA regulatory matters and other health care issues related to the human pharmaceutical industry. She has an undergraduate biology degree from Harvard College, a law degree from Georgetown University, and a master’s degree in public health from Johns Hopkins University.
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.