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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Cambridge, MA(Venue to be announced shortly)
November 6-7, 2014
What past attendees say about ComplianceOnline Seminars
I wanted to let you know that the speaker for this program (Michael Swit) was exceptional. He was professional, efficient, and went out of his way to help the attendees. Thank you. - Medical Director, Depomed, Inc
I thoroughly enjoyed the seminar! The content of the seminar was excellent. - Associate Director, Pfizer Global Supply
ComplianceOnline is doing well with organizing seminars and webinars. - Associate Director, Dr Reddy's Laboratories
Seminar was very good, informative and a lovely speaker making a tedious topic interesting. Overall the subjects are well chosen and the program was well organized and coordinated. - Director - Global IT Governance, Perrigo
The seminar is good. ComplianceOnline is doing well with organizing seminars and webinars. - Associate Director, Dr Reddy's Laboratories
The event was really well organized and ComplianceOnline staff helped make it a smooth process from initial registration, hotel bookings and seminar materials and stationery. I will be asking my company to send more employees to attend ComplianceOnline seminars. - Legal Advisor
I've attended quite a few seminars by different training providers but ComplianceOnline was by and far the best - the courses are well designed and up to date with the latest developments and the support staff are always helpful, ready to answer your queries. - Chief Executive Officer
The instructor was not only active and helpful during the seminar and workshop, but was available to answer resulting queries after the event as well. - Vice President
I think ComplianceOnline seminars are value for money - the instructors are well prepared and ready to go beyond and above the call of duty to answer even the most complicated of queries regarding subject. - Internal Auditor
Really good location with good lunch. This seminar was full of valuable topics. - System Admin, IT
This is my first experience with ComplianceOnline and I would definitely attend other seminars. - Business System Analyst
It was a very well organized in terms of course, venue and speaker. The content was complete and extremely interesting and I would definitely recommend this seminar to my co-workers.
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.
- Sr. Counsel, Siemens Medical Solutions USA, Inc
I had registered for a seminar but unfortunately I was not able to attend. The company was very understanding and extremely helpful. I plan on attending a future event soon. - Director of Regulatory Affairs, Nickell Physician & Pharmacy Services
The Harvard Museum of Natural History, located on the grounds of Harvard University, displays a sampling of specimens drawn from the collections of the university's three natural history research museums: the Harvard University Herbaria, the Museum of Comparative Zoology, and the Harvard Mineralogical Museum. The museum is physically connected to the Peabody Museum of Archaeology and Ethnology and one admission grants visitors access to both museums. In the museum’s permanent galleries, visitors encounter the diversity of life on earth, from dinosaurs to fossil invertebrates and reptiles, to large mammals, birds and fish, and the only mounted Kronosaurus. The mineralogical galleries present a systematic display of meteorites, minerals and gemstones. The galleries also house the historic Blaschka glass models of plants, popularly known as the Glass Flowers and a new exhibition, Sea Creatures in Glass, displaying some of Harvard Museum of Comparative Zoology's collection of Blaschka models of marine invertebrates. In addition, a series of changing exhibitions bring focus to new research at the university.
Longfellow House–Washington's Headquarters National Historic Site
The Longfellow House–Washington's Headquarters National Historic Site, also known as the Vassall-Craigie-Longfellow House, was the home of noted American poet Henry Wadsworth Longfellow for almost 50 years. On July 16, 1775, George Washington occupied the abandoned house as his first official headquarters. Henry Wadsworth Longfellow became its owner in 1843 and lived there until his death in 1882. The home, which represents the mid-Georgian architectural style, is seasonally open to the public. On display are many of the original nineteenth century furnishings, artwork, over 10,000 books owned by Longfellow, and the dining table around which many important visitors gathered. The site also possesses some 750,000 original documents relevant to the former occupants of the home. These archives are open to scholarly research by appointment.
Fresh Pond is a reservoir and park in Cambridge, Massachusetts. Prior to the pond's use exclusively as a reservoir, its ice had been harvested by Boston's "Ice King", Frederic Tudor, and others, for shipment to North American cities and to tropical areas around the world. Fresh Pond Reservation consists of a 155 acre kettle hole lake, and 162 acres of surrounding land with a 2.25 mile perimeter road popular with walkers, runners and cyclists, and a nine-hole golf course.
The Brattle Theatre is a repertory movie theater located in Harvard Square in Cambridge, Massachusetts. The theatre is a small movie house with one screen. It is one of the few remaining movie theaters, if not the only one, that use a rear-projection system; the projector is located behind the screen rather than behind the audience. The Brattle Theatre mainly screens a mixture of foreign, independent, and classic films, and began showing repertory and foreign films in February 1953. Despite the rapid disappearance of American art house theaters, the Brattle has managed to maintain a loyal base of moviegoers while remaining independently operated.
Fogg Art Museum
The Fogg Museum is the oldest of Harvard University's art museums. It is renowned for its holdings of Western paintings, sculpture, decorative arts, photographs, prints, and drawings from the Middle Ages to the present. Particular strengths include Italian Renaissance, British Pre-Raphaelite, and French art of the 19th century, as well as 19th and 20th century American paintings and drawings. The museum's Maurice Wertheim Collection is a notable group of impressionist and post-impressionist works that contains many famous masterpieces, including paintings and sculptures by Paul Cézanne, Edgar Degas, Édouard Manet, Henri Matisse, Pablo Picasso, and Vincent van Gogh. Central to the Fogg's holdings is the Grenville L. Winthrop Collection, with more than 4,000 works of art including important 19thcentury paintings, sculpture, and drawings by William Blake, Edward Burne-Jones, Jacques-Louis David, Honoré Daumier, Winslow Homer, Jean Auguste Dominique Ingres, Pierre-Auguste Renoir, Auguste Rodin, John Singer Sargent, Henri de Toulouse-Lautrec, and James Abbott McNeill Whistler.
Riverside Boat Club
The Riverside Boat Club is a private, non-profit, rowing club on the Charles River in Cambridge, Massachusetts. Founded in 1869 by workers from the Riverside Press, Riverside quickly established a reputation as a racing club, a tradition that continues today. While Riverside leaves learn-to-row opportunities to the many quality teaching programs on the Charles River, it is committed to providing quality rowing, coaching and equipment for all other levels, recreational rower through international competitor.
Charles River Reservation
The Charles River Reservation is a 17-mile-long Massachusetts state park located along the banks of the Charles River in Boston, Cambridge, Watertown, and Newton. The portion of the reservation between the Charles River Dam and the Eliot Bridge is listed as a historic district on the National Register of Historic Places. Features of the reservation include the Charles River Dam, the Charles River Basin, the Boston and Cambridge Esplanades, and John F. Kennedy Park.