Advocacy
Megan Anderson Brooks, PhD
President
Innovation Policy Solutions
Springfield, Virginia, United States
Session
Description: The decision to file a lawsuit against the FDA was not reached lightly. In this session you will hear from AMP members directly involved in the development and formulation of the legal complaint, along with AMP CEO, Laurie Menser, under whose leadership this decision was made. She will provide a unique perspective from an organizational standpoint. Additionally, legal expert and long-time AMP member, Roger Klein will weigh in on historical cases and recent legal challenges that have changed the regulatory landscape and the role they could play in potential outcomes.
Session
Objectives: To inform AMP membership about the significant decision to pursue legal action against the FDA due to the agency’s overreaching final rule that seeks to regulate LDPs as medical devices.
If this session topic is of interest to you, please consider looking at the following course on AMP EDucation (AMPED™ Online)
Title: AMP Resource Center on the FDA Final Rule on LDTs
Click here to learn more.
Breakout Speaker: Eric Konnick, MD, MS (he/him/his) – University of Washington
Breakout Speaker: Karen L. Kaul, MD, PhD (she/her/hers) – NorthShore Hospitals / Endeavor Health
Breakout Speaker: Laurie Menser (she/her/hers) – Association for Molecular Pathology
Breakout Speaker: Roger D. Klein, MD, JD – Center for Law, Science and Innovation, ASU Law School