Understanding the Food and Drug Administration
The Food and Drug Administration recently issued draft guidance to explain its approach to pre-dissemination review of direct-to-consumer (DTC) television advertisements. The draft guidance represents a significant change in FDA’s approach and attempts to provide detail on what steps advertisers should take and what enforcement steps, including civil and criminal penalties, may be expected.. If adopted, the Guidance will present significant compliance challenges for all companies in the industry.
Pharmaceutical companies and ad sponsors should have a complete understanding of FDA’s current thinking as reflected in this draft guidance to assess its potential impact on their business relations.
The Knowledge Group has assembled a panel of distinguished professionals and key regulators to help understand the complex issues related to the draft guidance and its impact on your firm and the broader market. The speakers will present their expert opinions in a two-hour LIVE Webcast.
- DTC Regulation
- FDA & FTC
- State authorities
- The Draft Guidance
- Categories of television ads covered
- The 45-day pre-dissemination submission
- Comments from Industry
- DTC in State and Federal Courts – WALSH
- Constitutional issues
- Commercial speech and compelled speech – First Amendment
- Due process and vagueness – Fourteenth Amendment
- Tort claims
- The learned intermediary doctrine
- Off-label promotion
- Constitutional issues
- DTC Compliance – HURON
- Planning the 45-day pre-dissemination submission
- Implementing requests for changes
- DTC Enforcement – ENGELMANN
- FDA –Options
- Untitled Letter
- Warning Letter
- Litigation (Lanham Act)
- Plaintiffs’ Litigation
- Interplay with CIA’s/StateSettlements
- FDA –Options
Who Should Attend:
- Bio/Pharma and Related Attorneys
- Advertising Attorneys
- Health Care Law Attorneys
- Health Industry Advisors
- Health Policy Directors
- Compliance Officers
- State Health Executives/Professionals
- General Counsel
- Senior Management
- Senior Executives
- Advertising/Marketing Officers
- Professionals coming from Food and Drug Industries
- Consultants & Clients in the Food and Drug Industries
Michael Walsh is a partner in the Dallas office of Strasburger & Price and leads the firm’s Drug and Device Industry Team. He devotes most of his practice to representing clients in FDA regulated industries on issues related to labeling and compliance and is a frequent speaker on issues concerning FDA labeling and marketing. Mike is also a member of the Laws and Regulations Committee of the Association of Food and Drug Officials and DRI Drug and Device Committee.
Michael Walsh is a partner in the Dallas office of Strasburger & Price and leads the firm’s Drug and Device …
Dr. DeWyngaert has provided operational, clinical, managerial, consulting, and litigation services to various segments of the health care industry. He trained as a molecular biologist and has been actively involved in both research and business development roles for the past 25 years. Mark specializes in assisting pharmaceutical manufacturers, biotechnology, and medical device companies with identifying and mitigating regulatory risks and valuing intellectual property.
Mark regularly leads teams in the assessment of medical affairs and clinical development activities and assists companies in the redesign of business practices to comply with applicable regulations and standards. He also serves clients and their legal counsel in fraud investigations, compliance inquiries, litigation strategy issues, and acting as an expert witness.
Dr. DeWyngaert has provided operational, clinical, managerial, consulting, and litigation services to various segments of the health care industry. He …
Brad has more than 16 years’ experience advising pharmaceutical, biotechnology, and medical device clients on issues of strategic growth, process improvement, and quality systems optimization. Brad delivers solutions focused on the transformation of core business and scientific processes from R&D, through commercial launch, with a particular emphasis on regulated clinical operations improvement.
Brad has more than 16 years’ experience advising pharmaceutical, biotechnology, and medical device clients on issues of strategic growth, process …
Glenn Engelmann is Senior Counsel in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C. office. In advising clients, he leverages his 25 years of experience managing complex legal and regulatory matters in the pharmaceutical industry. As the Vice Chair of McDermott’s multi-disciplinary global Life Sciences Industry Group, Glenn is integral to the ongoing development of the growth of this important part of the firm’s practice. Prior to joining McDermott, Glenn served as a member of Astra Zeneca’s executive leadership team responsible for managing the U.S. business. In this role, he provided advice and support to company leadership in addressing a wide range of legal and regulatory matters including defending multiple Federal and State investigations and patent challenges. For the last two and a half yearsof his tenure , he was responsible for the legal support for the global sales and marketing organization as well. In 2012, Glenn was selected as a Life Science Star by LMG Life Sciences. He is a member of the D.C. bar and is also past chair of the PhRMA Law Section Executive Committee.
Glenn Engelmann is Senior Counsel in the law firm of McDermott Will & Emery LLP and is based in the …
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About Strasburger & Price, LLP
Strasburger & Price, LLP is an AmLaw 250 law firm offering clients a broad range of legal services in over 30 practice areas. The firm represents international, national and middle market Texas-based companies with the goal of finding effective business solutions while complying with the highest standards of character, professionalism and understanding. To learn more Strasburger’s rich history, diverse areas of practice and experienced attorneys, visit www.strasburger.com.
About Huron Consulting Group
Huron Life Sciences assists the continuum of life sciences organizations from pharmaceutical companies and device manufacturers, to academic medical centers and hospitals, to universities and research institutes, to the law firms and other organizations that support the life sciences industry. Our team is comprised of experienced consultants and subject matter experts with many years of business, scientific, industry, and regulatory experience. We help our clients improve their regulatory compliance, increase efficiencies in their clinical research enterprises, and achieve their financial and operational objectives. For more information, please visitwww.huronconsultinggroup.com.
About McDermott Will & Emery
McDermott Will & Emery has one of the largest and most prestigious Health law practices in the world, counseling leading organizations in every major sector of the health and life sciences industry on legal, regulatory and business transaction issues. For the second consecutive year Chambers USA ranked the Firm’s Health practice as the only Tier 1 Health Practice in the United States. The Firm’s Life Sciences Industry Group is also nationally ranked by Chambers USA, and this group of 135+ lawyers, patent agents and scientific advisors provides the full range of legal services required by life sciences companies, regardless of their stage of development.