Product Details
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Drug and device manufacturers can ensure compliance with the FDA’s advertising and promotion guidelines by attending this introductory presentation.
You will come away with a solid grasp of advertising and promotion principles, including the requirements for promotion (incorporating claims substantiation, fair balance and off-label promotion) and the key differences between drug and device promotion.
Covington & Burling LLP’s Stefanie A. Doebler, a Partner, and Christopher Hanson, Special Counsel, will use case studies from recent enforcements to explain the most important risk areas, so you can avoid them.
Presentation Takeaways:
- Key statutory definitions used in the Federal Food, Drug and Cosmetic Act (FD&C Act), such as misbranded, labeling and false and misleading
- The primary requirements for advertising and promotion set forth in the FD&C Act and implementing regulations
- The FDA’s recent guidance on promotion consistent with the approved labeling described in its 2019 guidance, “Medical Product Communications That Are Consistent With the FDA-Required Labeling”
- The scope of the prohibition on preapproval promotion, 21 CFR 312.7, 812.7
- The difference between promotion and disease awareness communications, described in FDA’s draft guidance, “‘Help-Seeking’ and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms”
What you don’t know about drug and device advertising and promotion will hurt you. Arm yourself against violations with this presentation.
Meet Your Presenters
Stefanie A. Doebler, a Partner at Covington & Burling LLP, is co-chair of the firm's healthcare practice group and a member of the food, drug and device practice group. She focuses on healthcare compliance matters for pharmaceutical, biotech and medical device clients. She provides advice related to advertising and promotion, fraud and abuse, transparency requirements, state law compliance and reporting regulations, interactions with healthcare professionals, Medicaid price reporting and other aspects of federal and state regulation of pharmaceuticals, biologics and medical devices. Ms. Doebler also advises on the development and implementation of healthcare compliance programs.
Christopher Hanson, a Special Counsel at Covington & Burling LLP, assists clients in tackling their most sophisticated and high-stakes regulatory issues involving medical devices, in vitro diagnostics, clinical laboratories and radiation-emitting electronic products. For nearly a decade, he has aided clients in interactions with federal, state and foreign regulatory agencies, including the FDA, the Centers for Medicare and Medicaid Services (CMS), the Federal Trade Commission (FTC) and the Substance Abuse and Mental Health Services Administration (SAMHSA). His broad range of clients includes large multinational companies, venture capital firms, industry associations and development-stage companies. Mr. Hanson takes a hands-on approach in crafting creative and practical solutions for clients, including drafting legislation as well as preparing public comments for agency rulemakings, guidance documents, advisory committees and other public policy venues. He provides strategic advice and regulatory due diligence to support corporate transactions and securities filings. Mr. Hanson also has experience advising in enforcement matters and conducting global internal investigations and audits of the firm’s life science clients in the U.S., Asia, Australia, Europe and Latin America.
Who Will Benefit
- Quality Specialists
- Regulatory Specialists
- Compliance Specialists