BRADLEY MERRILL THOMPSON is a Member of the Firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues.
Mr. Thompson regularly defends companies receiving FDA warning letters, on a wide gamut of subjects including good manufacturing practice compliance and off label promotion. He frequently counsels companies on premarket clearance and approval strategies and on marketing strategies. When medical device companies become concerned that perhaps their employees have not followed FDA requirements, they often engage Mr. Thompson to investigate. With a special focus on drug delivery companies, Mr. Thompson also advises such companies on the unique aspects of combination product development and manufacturing.
For trade associations, Mr. Thompson has served as regulatory counsel for Continua Health Alliance; as counsel to AdvaMed for payment issues; as General Counsel to the Combination Products Coalition, the mHealth Regulatory Coalition, and the CDS Coalition (focusing on clinical decision support software); and for 17 years, as General Counsel and Secretary for the Indiana Medical Device Manufacturers Council (the "IMDMC").
For over 25 years, Mr. Thompson has focused on administrative law issues, particularly on the best ways for agencies and the public to work together in defining new regulatory policy and guidance. In the mid 1990s, on behalf of the IMDMC and about a dozen large trade associations representing virtually every industry the FDA regulates, Mr. Thompson advocated that FDA should improve its guidance development process to enhance the quality and reliability of guidance as well as to better ensure public participation. Mr. Thompson's advocacy resulted in the so-called FDA Good Guidance Practices, now embraced by other federal agencies, as well. In the late 1990s, Mr. Thompson successfully advocated that what is now called the Centers for Medicare & Medicaid Services should conduct its coverage decision-making process more openly, and in particular should permit public attendance at its advisory committee meetings.
In legislative matters, Mr. Thompson has over the years actively worked to ensure that health care economic information can be appropriately shared without running afoul of FDA requirements, and seeking to secure stakeholders a reasonable avenue of appeal when Medicare contractors deny claims. In both cases, Congress enacted responsive legislation.
He has taught food and drug law at Indiana University School of Law—Indianapolis and Columbia Law School. Mr. Thompson also serves as Co-Chair of the Food & Drug Law Committee of the Administrative Law Section of the American Bar Association, and of the Medical Device Committee of the Food & Drug Law Institute.
Mr. Thompson was elected by his peers as a Fellow of the American Bar Association, and he has received an "AV Preeminent" Peer Review Rating by Martindale-Hubbell, signifying the highest level of professional excellence. He was included in 100 Notable People in the Medical Device Industry (Medical Device & Diagnostics Industry, June 2004) and has been listed in Chambers USA: America's Leading Lawyers for Business (2010 to 2013). He was also selected for inclusion in Indiana Super Lawyers (2004 to 2006) and Washington, DC Super Lawyers (2013 to 2014).
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