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Christine P. Bump, principal and founder of Penn Avenue Law & Policy, is an insightful regulatory attorney with two decades of experience developing and implementing FDA strategies for devices, diagnostics, digital health platforms, and genetic and genomic tests. She advises laboratories, large corporations, and emerging companies with an awareness and understanding of their business and strategic goals. Christine has served as regulatory counsel for a national diagnostic coalition, written several articles, and presented at numerous industry conferences. Before starting her firm, she practiced at Hyman, Phelps, & McNamara, P.C. and in the Life Sciences group at Goodwin. Christine earned a B.A. from Sweet Briar College, an M.P.H. from Emory University’s Rollins School of Public Health, and a J.D. from Emory University School of Law.
The Supreme Court of the United States’ recent decision in Loper Bright Enterprises v. Raimondo weakened FDA’s defense of its authority to regulate laboratory developed tests (LDTs) as devices. Loper Bright overturned the Chevron doctrine, which had required courts to defer to federal agencies’ interpretations of ambiguous statutes. Courts must now exercise independent judgment in deciding whether an agency has acted within its authority.
Loper Bright has a direct impact on the pending lawsuit against FDA by the American Clinical Laboratory Association (ACLA), which challenges the agency’s authority to issue and enforce the LDT final rule. The decision also serves as a basis for Congressional inquiries into FDA’s authority, and will likely influence new legislation that promises to create less burdensome regulations for laboratories.
This webinar will explain the Loper Bright decision and the potential effect on regulation, legislation, and lower court decisions that impact laboratories.
