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.
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
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.
Michael A Swit, Esq., FDA Lawyer
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:
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.
Interview with Michael A Swit, Esq., FDA Lawyer
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.
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Schaumburg, IL (Venue to be announced shortly)
September 11-12, 2014
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ComplianceOnline has chosen a very good venue.
- Regulatory Advertising Officer, Health Canada
Interaction between the speaker and audience was interesting. - DVM, Merial
This was tremendously informative and very full of interesting insights. I especially enjoyed going over the warning letters. - Program Manager, Regulatory Affairs, Genentech, Inc.
Instructor is experienced and was willing to share his experiences. - Marketing Manager, Minerva Surgical, Inc
Seminar covered more latest up- to- date information. - Regulatory Affairs Specialist, AccessClosure, Inc
Michael has a good accessible presentation style and was very colloquial. He welcomes questions from attendees and has the answers also. He also promoted good interaction between attendees.
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Entertainment complex. Enjoy games, food, drinks and music. Featuring Steven Spielberg's new virtual reality game Sky Pirates where participants are strapped and experience the physical consequences of their performance in the game.
Spring Valley Nature Sanctuary Schaumburg
A seemingly endless amount of walking and hiking paths work their way through over 135 acres of forest, prairies and wetlands. The sanctuary is home to a farmhouse dating back to 1880 that has been filled with exhibits and artifacts about that period of time.
Atcher Island Waterpark Schaumburg
This theme water park has water slides, a unique circular drop slide, children’s spray ground and more. The park also has a concession and children's playground.
Medieval Times Dinner & Tournament
European style castle housing a 1426 seat theater-style Arena. Dine on a four course medieval meal and watch knights in shining armor compete in jousting.
Trickster Gallery is an extension of the American Indian Center of Chicago. It is the only non-profit Native operated arts institution in the State of Illinois and is dedicated to providing space for first-voice arts. Trickster Gallery features contemporary Native art (post 1960s) and augments exhibits with film screenings, featured speakers, panel discussions, school tours and educator workshops.
Volkening Lake Schaumburg
Walking paths wind their way through the park and down the banks of Volkening Lake. Visitors can fish and rent paddle boats or canoes in lake. Throughout the park a variety of flowers and gardens line the pathways. A small concession stand sells food and beverages.
The Sport Center
This 100,000 sq. ft. indoor sports center features basketball courts, soccer fields, baseball/softball diamonds and a gymnastic facility. Practice and training areas can be rented here.