James S. Cohen Joins McDermott Will & Emery to Lead the FDA practice

WASHINGTON, D.C. —  McDermott Will & Emery is pleased to announce that James S. Cohen will join the Firm’s Health Industry Advisory and Life Sciences & Medical Devices Practice Groups as a partner and leader of the firm's FDA practice in the Washington, D.C. office on July 27th.  Mr. Cohen focuses his practice on the development, clinical investigation, approval, manufacturing, distribution, and marketing of pharmaceuticals, biologics, medical devices and combination products.  A significant portion of his practice is devoted to counseling and defending clients in compliance investigations and enforcement actions undertaken by the U.S. Food & Drug Administration (FDA), U.S. Department of Justice and other Federal and State agencies. 

Mr. Cohen spent more than 17 years in senior FDA regulatory positions, including as Deputy and Acting Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, and as Associate Chief Counsel for Enforcement, Drugs, and Biologics.  He joins McDermott from the Washington office of a national law firm.
 
“The addition of Jim further strengthens our group’s ability to help life sciences clients throughout their complete life cycle,” said Stephen Bernstein, leader of the Firm’s international Health Industry Advisory Practice Group.  “The Patient Protection and Affordable Care Act’s overhaul of the nation’s health care system poses immense regulatory and cost containment challenges, especially for pharmaceutical, biotech and medical device innovations.  Jim’s extensive experience overseeing the FDA approval process in these areas adds a valuable dimension to our leadership in the life sciences and health care sectors.” Mr. Bernstein added, "Jim's experience in defending regulated companies and products in a period of unprecedented enforcement activity by the federal government deepens the scope of our practice as well."

Pharmaceutical, biologic and medical device clients rely on Mr. Cohen to advise and represent them in all phases of pre-market review and post-market regulation.  Representative matters that he handles include oversight of clinical investigations, product application issues, product jurisdiction issues, response and defense to FDA inspection, compliance and enforcement actions, defense to Department of Justice investigations, advertising and promotion, recalls, citizen petitions, and CMS coverage and rebate issues. As a leader of the FDA Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, he directed and managed the agency's activities in these areas for biological products (including biological drugs and devices) and oversaw a variety of compliance issues. 

In addition, Mr. Cohen served for eight years as Associate Chief Counsel in the Office of the Chief Counsel (OCC) at the FDA, where as an enforcement attorney he conducted civil and criminal enforcement litigation in all major product areas regulated by the FDA. During this time, he also served as a Special Assistant United States Attorney in three federal jurisdictions.  He received numerous awards at the FDA, including the Award of Merit and Distinguished Service Award, and served in the federal government's Senior Executive Service.

Mr. Cohen has spoken on FDA regulation at numerous conferences and programs, domestically and internationally, to product manufacturers, industry organizations and government officials. He is admitted to practice in the District of Columbia, in Massachusetts and before a number of federal courts, including the U.S. Supreme Court.  Mr. Cohen received his J.D. degree from Georgetown University Law Center, Washington, D.C., in 1983.

“Jim’s arrival enhances our group’s ability to help life sciences companies with the industry’s unprecedented business and legal changes,” stated William Gaede, co-chair of the Firm’s Life Sciences & Medical Devices Practice Group.  “His long tenure at the FDA provides him with a unique and complete perspective for our clients on the development, marketing and regulatory oversight of drugs and devices.”

McDermott’s Life Sciences & Medical Devices Practice Group provides fully integrated, multidisciplinary legal services to life sciences companies, regardless of their stage of development. Life Sciences is a major focus of McDermott and in recent years has enhanced its resources with the addition of leading pharmaceutical, biotechnology and medical device practitioners.  McDermott’s Life Sciences & Medical Device Practice Group is nationally recognized by Chambers USA for its impressive work advising clients on regulatory, corporate partnering and intellectual property matters.  Chambers USA, 2010, notes that, “[McDermott] has developed an impressive life sciences and medical devices group, advising clients on regulatory, corporate partnering and IP matters.”

Teaming with the Firm’s Life Sciences & Medical Devices practice, the Firm’s Health Industry Advisory Practice Group was named 2010 “Health Team of the Year” by Chambers USA, the first such national award by Chambers.  McDermott also is the only law firm to earn a 2010 Tier 1 ranking in the first-ever national health law rankings by Chambers USA, reflecting overall pre-eminence and precedent-setting work in the health care sector.  As one of the largest and most prestigious health law practices in the world, the Firm’s 80-lawyer Health Industry Advisory group counsels leading organizations in every major health care and life sciences sector on transactional, regulatory and dispute resolution matters.  

McDermott Will & Emery is a leading international law firm with a diversified business practice.  Numbering more than 1,000 lawyers, we have offices in Boston, Brussels, Chicago, Düsseldorf, Houston, London, Los Angeles, Miami, Milan, Munich, New York, Orange County, Rome, San Diego, Silicon Valley and Washington, D.C., as well as a strategic alliance with MWE China Law Offices in Shanghai.  For more information see www.mwe.com.