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Critical Regulatory Changes Governing the Marketing of Pharmaceuticals & Biotech Products - How Will It Affect Your Firm? LIVE webcast
Arnold I. Friede, Esq.
Counsel, Former Associate Chief Counsel, Food and Drug Administration
McDermott Will & Emery LLP
Arnold I. Friede is counsel to the law firm of McDermott Will & Emery LLP based in its Washington, D.C. office. Arnie is a member of the Firm’s Health Law Department. Arnold I. Friede is a widely respected food and drug law counselor and advocate with significant advertising law, health care law, First Amendment, environmental, and commercial and transactional experience. He has a long history of direct involvement in successfully representing clients in FDA-regulated matters beginning as an Associate Chief Counsel in the FDA Chief Counsel’s Office, as well as a broad spectrum of senior in-house legal experience across multiple FDA-regulated industries.
Arnie has had a distinguished career of highly responsible, diverse, and complex positions. He served in government as a law clerk in Federal District Court in Los Angeles, and then with the Federal Judicial Panel on Multidistrict Litigation in Washington, DC, and as an Associate Chief Counsel in the FDA Chief Counsel's Office in Rockville, Maryland. Afterwards with Richardson-Vicks in Wilton, Connecticut, and then with several divisions of Unilever United States, including as General Counsel of Unilever’s U .S. food business in New Jersey, and then as senior corporate counsel with Pfizer in New York, Mr. Friede has been involved for nearly 35 years in a broad range of FDA and other agency-regulated businesses, including the life sciences, such as pharmaceutical and biotech, medical device, medical information, disease management, and over-the-counter drugs, as well as in the food, cosmetic, chemical and other industries. He has a breadth and depth of experience across an array of substantive legal areas and business operations.
Mr. Friede received his B.S. degree in Mathematics from the University of Pittsburgh and his J.D. from the George Washington University School of Law. In addition to numerous other professional affiliations, he is a past-Chairman of the Food, Drug, and Cosmetic Law Section of the New York State Bar Association.
Arnie is a frequent speaker and author on a wide range of topics of interest to the pharmaceutical, biotech, medical device, and life science industries generally.
Mr. Friede is admitted to practice in California, Connecticut, the District of Columbia, and Maryland.
Robert N. Weiner, Esq.
Partner, Former Senior Counsel, White House Counsel's Office
Arnold & Porter
Robert Weiner has headed Arnold & Porter LLP's litigation and business litigation practice groups. Ranked in numerous surveys as one of the best litigators in the US, Mr. Weiner has substantial experience as a trial lawyer and appellate advocate in criminal and civil cases. His experience includes:
- Serving as national coordinating and trial counsel in product liability and toxic tort cases involving, among
other things, diet drugs, heart valves, pharmaceutical products, and lead paint.
- Representing clients in media-intensive congressional investigations and regulatory inquiries, as well
as in confidential, criminal, and disciplinary investigations.
- Representing the State of Israel in litigation involving national security policies.
In 1997-98, Mr. Weiner served as Senior Counsel in the White House Counsel’s Office. As “in-house” counsel in the White House, he dealt with the legal aspects of major legislative and public policy issues confronting the nation, from global warming and civil rights to financial reform and privacy. Mr. Weiner has also taught Mass Torts at the University of Virginia School of Law and Complex Criminal Litigation at the Georgetown University Law Center. In 1987, Mr. Weiner served as an Associate Independent Counsel in the Wedtech prosecution. Mr. Weiner clerked for Judge Henry Friendly of the US Court of Appeals for the Second Circuit and for Supreme Court Justice Thurgood Marshall.
Kelly N. Reeves
Partner
King & Spalding LLP
Nikki Reeves is a partner in King & Spalding’s FDA & Life Sciences Practice Group in Washington, D.C. She counsels pharmaceutical, biotechnology, and medical device companies on a broad range of FDA and healthcare regulatory compliance matters, including clinical trial regulation, product advertising, labeling, postmarket safety reporting, quality system regulation/good manufacturing practices, FDA enforcement, and state laws targeting pharma and device companies. Ms. Reeves has also advised clients in the food and cosmetic industries.
Ms. Reeves is a frequent speaker for the Food and Drug Law Institute and American Health Lawyers Association. She has published several articles on FDA regulation of medical device and prescription drug advertising/promotion and new state laws regulating drug and device industry marketing practices. Prior to law school, Ms. Reeves worked for GlaxoSmithKline and Kaiser Permanente.
James E. Dutton
President Emeritus, CMR Institute, Executive Advisor, Advocacy and Strategic Development, Medical Representatives, Certification Commission
CMR
Executive Advisor, Advocacy and Strategic Development, Medical Representatives Certification Commission (MRCC) and President Emeritus, CMR Institute
Jim Dutton is Executive Advisor, Advocacy and Strategic Development for the Medical Representatives Certification Commission (MRCC’s mission is to improve patient outcomes by certifying the professional competency and ethical conduct of medical representatives, increasing their value to healthcare providers) and is President Emeritus of the CMR Institute, an independent, not-for -profit 501 (c)(3) educational organization. Mr. Dutton joined the CMR Institute in 1984, served as its President from 1989 to 2009, and was honored by being named President Emeritus of the Institute earlier this year. In his role presiding over an organization long recognized as the industry leader in education, he has been dedicated to providing pharmaceutical and biotech industry representatives and managers with the highest quality continuing education, professional development, and certification through increasingly innovative learning strategies and a greatly expanded and enhanced curriculum of more than 40 courses in science and medicine, disease management, the business of healthcare and pharmaceutical management.
Mr. Dutton’s leadership and commitment to advancing industry education was recognized in 1998 when the Society of Pharmaceutical and Biotech Trainers (SPBT) bestowed on him the Frank and Anne Walsh Distinguished Service Award, named for the SPBT’s founders and established to recognize outstanding dedication and service. Mr. Dutton was inducted into the SPBT Hall of Fame in 2001 and today serves on its Board of Directors as the first and only director to be elected from outside the industry. Mr. Dutton is well known in the industry as an advocate for expansive and in-depth medical representative education, and for pro-active national, industry-wide certification. He currently serves on the Editorial Advisory Board of Pharmaceutical Representative.
A Certified Medical Representative (CMR) since 1975, Mr. Dutton worked for 17 years in the pharmaceutical industry for Warner-Chilcott Laboratories and Parke-Davis, both divisions of Warner Lambert, and for the Mead Johnson Pharmaceutical Division of Bristol-Myers Squibb before joining the Institute in 1984. Mr. Dutton holds a Master’s Degree in Science from Virginia Tech.
Critical Regulatory Changes Governing the Marketing of Pharmaceuticals & Biotech Products - How Will It Affect Your Firm?
Speaker Firms:
Arnold & Porter
King & Spalding LLP
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