Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well as key recent trends in enforcement activities by the Federal Government. This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena.
What’s at stake if your advertising and promotional efforts violate the law? Colossal fines – the latest was $3 Billion; criminal liability, including even prison time; and huge disruption in operations while dealing with federal probes into illegal marketing.
Seminar Fee Includes:
- AM-PM Tea/Coffee
- Seminar Material
- USB with seminar presentation
- Hard copy of presentation
- Attendance Certificate
- $100 Gift Cert for next seminar
- Download Brochure
Key goals of the conference will include learning:
- The basics of FDA law and regulations governing advertising and promotion, as well as sister agencies such as the Federal Trade Commission, which shares jurisdiction with FDA on certain regulated products (e.g., OTC drugs).
- The distinctions between labels, labeling and advertising and how that impacts FDA's powers, and
- How to properly position Direct-to-Consumer (DTC) promotions
- The Dos and Don'ts of promoting products on the internet, including social media sites such as Facebook and Twitter
- The perils of off-label promotion, including criminal and civil actions that have led to multi-billion dollar settlements by regulated drug companies
- Whether the First Amendment provides any insulation for truthful statements regarding regulated products;
- When disseminating medical educational materials crosses the line into improper promotion; and
- Key considerations on how to implement appropriate procedures and controls in your company to minimize the potential for regulatory action by the FDA or the FTC relative to promotion and advertising.
DAY ONE (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
I. Understanding the Basics
Who Has Jurisdiction
Drugs & Biologics
Rx Drug Advertising
OTC Drug Advertising
all other Labeling vs. Advertising
Basic drug rules
Intended use deviations
Comparative Claims standard to support
push to pursue CER
Detailing and Sampling
is there still a future?
what can be said?
danger of “custom” pieces
How FDA learns of violations
Keep your house clean or your competitors will rat you out
II. Scientific Exchange
Guidances on Dissemination of Scientific Information
Risks involved in OffLabel Statements
Procedural Requirements and Unsolicited Requests for Information
III. First Amendment
Understanding “Commercial Speech” Doctrine
FDA and the Regulation of Advertising
IV. Websites & Social Media
FDA Policies on the Internet
Recent FDA Enforcement Activities
How to Handle at the Company Levels
DAY TWO (8:30 AM – 4:30 PM)
V. Enforcement Trends
FDA Hot Buttons
POM Wonderful and substantiation
Private Litigation – Understanding
State Unfair Competition
VI. False Claims Act and Criminal Liability
Review of Key Settlements
“Responsible Corporate Official” Liability
VII. Handling at the Company Level
Mr Michael A Swit, Esq.,
FDA Lawyer ,
U.S. Food & Drug Administration
Michael A. Swit focuses on solving the legal challenges confronted by the pharmaceutical, medical device, and other life sciences industries in tackling the myriad of legal mandates enforced by the U.S. Food & Drug Administration. Mr. Swit has extensive experience counseling life sciences firms on the demands of compliance with FDA's statutory and regulatory requirements to develop and market safe and effective drugs, biologics, medical devices, IVDs and other products. He also has advised regulated firms on a wide range of FDA regulatory matters, including drug and device approvals and marketing/promotional claims, dietary supplement health claims and regulatory issues in corporate acquisitions. His experience includes FDA development strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts.
Mr. Swit has been addressing critical FDA legal and regulatory issues since 1984. Before joining Duane Morris LLP, Mr. Swit served for seven years as vice president at a preeminent scientific and FDA regulatory consulting firm, where he developed and ensured execution of a broad array of regulatory and other services to clients, both directly and through outside counsel.
His multi-faceted experience includes serving for three and a half years as corporate vice president, general counsel and secretary of Par Pharmaceutical, a prominent, publicly-traded, generic drug company and, thus, he brings an industry and commercial perspective to his work with FDA-regulated companies. While at Par, he spearheaded Par's successful response to multiple federal and state criminal and civil investigations arising out of the actions of prior management. Mr. Swit then served for over four years as CEO of FDAnews.com, a premier publisher of FDA regulatory newsletters and other specialty information products for the FDA-regulated community. His private FDA regulatory law practice also has included service as counsel in the FDA practices of three international law firms, as well as a solo FDA practitioner.
Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the Food & Drug Law Journal Editorial Board, Mr. Swit also has been a prominent speaker at numerous conferences sponsored by such organizations as the Food & Drug Law Institute (FDLI), the Regulatory Affairs Professionals Society (RAPS), and the Drug Information Association (DIA).
Mr. Swit is a 1982 graduate of Emory School of Law and a magna cum laude graduate of Bowdoin College (1979), with high honors in history
Who will Benefit:
Senior executives, directors, managers and those who have responsibility for implementing advertising and promotional activities, as well as those that have key collateral roles in reviewing advertising for drug and device firms, including officials from these areas within regulated companies:
- Medical Affairs
Venue to be announced shortly.