American Society for Pharmacy Law
ROUNDTABLE DISCUSSIONS

 

Join us for thought-provoking discussions with your fellow ASPL members, the 3rd Wednesday of each month.  Registration is complimentary to all ASPL members.

 

 


 

 

Friday, September 9, 2022
12:00 – 1:00 pm Central
The Impact of Roe v. Wade's Reversal on Pharmacies and Pharmacists

In June 2022, the Supreme Court of the United States issued a landmark decision in Dobbs v. Jackson Women's Health Organization when it held that the U.S. Constitution does not confer a right to abortion and overruled precedent set in both Roe v. Wade and Planned Parenthood v. Casey. With almost half of abortions in the U.S. occurring via medication, the Dobbs decision has prompted several questions regarding the role and scope of pharmacies and pharmacists in dispensing reproductive medications for either on or off label use, while complying with applicable state law, in a post-Roe world. This roundtable features legal experts who will analyze the Dobbs decision through the lens of questions that have arisen regarding federal and state laws impacting the distribution and dispensing of pregnancy terminating medications (e.g., Mifepristone and Misoprostol), as well as other medication used for reproductive health (e.g., Plan B). This roundtable will also examine federal and specific state laws that have limited or expanded the pharmacist’s role in dispensing (or refusing to dispense) abortifacients and other reproductive health medications.

Speakers:
Delia Deschaine is partner at Epstein Becker & Green, P.C., where she focuses her practice on advising pharmaceutical and biotechnology clients on a broad range of U.S. Food and Drug Administration regulatory matters, including the Drug Supply Chain Security Act compliance. Delia also focuses on the federal and state regulation of controlled substances and other medications, defending pharmaceutical and biotechnology companies, distributors and pharmacies in government investigations, litigation, and compliance with Drug Enforcement Administration and related state law regulatory requirements. Most recently, Delia provides advice to her clients on the implications of the U.S. Supreme Court’s decision in Dobbs v. Jackson Women's Health Organization and has been a featured thought leader on the topic in publications including Bloomberg Law. Delia received her J.D., cum laude, with a Health Law Certificate from the University of Maryland Francis King Carey School of Law and a B.A. from Manhattanville College.

Mary Ellen Kleiman is Vice President, Legal Affairs and Senior Counsel for the National Association of Chain Drug Stores.  In her role, Mary Ellen serves as in-house legal counsel to NACDS and as a legal resource to NACDS members on matters related to pharmacy compliance, liability, and enforcement matters, among others.  Prior to joining NACDS, she was with Akin, Gump, Strauss, Hauer, & Feld, L.L.P. in their DC office.  Mary Ellen is a graduate of Northwestern University and the Columbus School of Law of the Catholic University of America. From 2008-2013, she served on the Board of the American Society for Pharmacy Law.

Kala Shankle deftly navigates clients through pharmacy laws and drug pricing, reimbursement, and supply chain issues. Her legal counsel is guided by a deep understanding of a client’s business and objectives, coupled with the dynamics of federal and state regulatory landscapes.
For retail and specialty pharmacies, pharmacy benefit managers, insurers, and other health care providers and suppliers, Kala counsels on drug reimbursement by private insurers and government programs, 340B drug program compliance and management, supply chain laws and regulations, and provider licensure and accreditation. She also advises on compliance with fraud and abuse, cannabis, state and federal COVID-19 regulations, and patient/consumer data privacy laws. Separately, she provides guidance to organizations on nonprofit compliance issues.

 

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