Overview
In mid-August, the U.S. Department of Health and Human Services (HHS) announced that FDA would no longer require premarket review of laboratory developed tests (LDTs) (tests designed, manufactured, and used within a single laboratory), absent future legislation or notice and comment rulemaking. On October 7th, FDA announced that it would no longer review emergency use authorization requests for LDTs. There are competing views about whether FDA had previously overstepped its authority over LDTs and whether these changes could cause unreliable tests, including COVID-19 tests, to enter the market. This webinar will examine the history of FDA’s LDT regulation, HHS’s legal authority for revoking FDA’s premarket review process, whether the HHS announcement followed proper administrative law procedures, the effect of the HHS and FDA announcements on FDA’s regulation of both COVID-19 and non-COVID-19 LDT tests and FDA’s future use of enforcement discretion generally, and the progress of pending diagnostic reform legislation.
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Speakers
Alberto Gutierrez, Partner, NDA Partners LLC
Peter Lurie, Executive Director, Center for Science in the Public Interest
Tom Sparkman, Senior Vice President, Government Affairs and Policy, American Clinical Laboratory Association
Moderated by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC
JEFFEREY N. GIBBS is a director in the Washington, DC law firm of Hyman, Phelps & McNamara, P.C. Before entering private practice, he was an Associate Chief Counsel for Enforcement at the Food and Drug Administration. He previously served as General Counsel and then as Chairman of FDLI’s Board of Directors. Jeff assists in vitro diagnostic and medical device companies with a variety of regulatory issues, including FDA product clearance and approval, product labeling, clinical studies, promotional and marketing programs, appeals, regulatory strategy, FDA enforcement actions, emergency use authorizations, citizen petitions, and laboratory developed tests. He has written extensively on FDA issues, including those involving diagnostic products, and has advised IVD companies on a wide range of FDA regulatory and strategic issues. He received FDLI’s Distinguished Service and Leadership Award in 2013, LMG Life Sciences FDA Medical Device Attorney of the Year Award in 2013, and was inducted to LMG Life Sciences Hall of Fame Award in 2018. Jeff previously served on the Human Subjects Review Board of George Mason University, and is currently teaching medical device law at George Washington University. Jeff graduated from Princeton University and New York University School of Law. Jeff is co-editor and co-author of FDLI’s forthcoming book on IVD regulation.
Peter Lurie, MD, MPH is President and Executive Director of CSPI. Previously, Lurie was the Associate Commissioner for Public Health Strategy and Analysis at the Food and Drug Administration, where he worked on antimicrobial resistance, transparency, caffeinated beverages, arsenic in rice, fish consumption by pregnant and nursing women, expanded access to investigational drugs, and prescription drug abuse. Prior to that, he was Deputy Director of Public Citizen’s Health Research Group, where he addressed drug and device issues, coauthored the organization’s Worst Pills, Best Pills consumer guide to medications, and led efforts to reduce worker exposure to hexavalent chromium and beryllium. Earlier, as a faculty member at the University of California, San Francisco and the University of Michigan, he studied needle exchange programs, ethical aspects of mother-to-infant HIV transmission studies, and other HIV policy issues domestically and abroad.
Tom Sparkman was named Vice President for Government Relations in March 2013. Prior to joining ACLA, Mr. Sparkman was a senior lobbyist at a top lobbying firm in Washington representing biotech and medical device innovators, hospitals and other providers, among others. Joining the firm in 2008, he helped build coalitions on and off Capitol Hill to achieve his client’s legislative and policy goals. Mr. Sparkman has also held positions with the National Association of State Medicaid Directors, the National Association of Chain Drug Stores, in addition to being a practicing pharmacist in Northern Virginia. He holds a Bachelor of Pharmacy from Rutgers University, a Master of Public Policy from Georgetown University, and a Juris Doctor from American University and is licensed as a pharmacist in Virginia and an Associate Member of the Virginia State Bar.Virtual Learning FAQ
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