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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Courtyard Boston Cambridge
777 Memorial Drive,
Cambridge, MA, 02139, USA
From Boston Logan International Airport – BOS: 7.3 mile(s) W:
Exit Airport and take MassPike (I-90) West to Exit 20 (Cambridge)
Continue straight and cross bridge
Take first right after bridge onto Memorial Drive
Hotel is 200 yards ahead on the left.
From Manchester-Boston Regional Airport – MHT: 55.1 mile(s) SE
Follow I-293 to I-93S towards Boston
Take exit 26B (Storrow Drive West) and continue for 3 miles
Bear right at the Central Square/MassPike exit and turn right at the light
After crossing the bridge, take first right onto Memorial Drive and Hotel is on the left.
From T F Green Airport – PVD: 62.1 mile(s) NE
Take I95N to I93N
Then, take exit 26 (Storrow Drive West) and follow Storrow Drive
Take the Central Square/MassPike exit and turn right at light
After crossing the bridge, take first right onto Memorial Drive and Hotel is on the left.
South Station: 5 mile(s) SE
B.U. Central (on the Green Line): 0.8 mile(s) SE
Central Station (on the Red Line): 0.8 mile(s) NE
Back Bay Station (BBY): 3 mile(s) SE
South Station (BOS): 5 mile(s) SE
Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.
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
This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.
Boston Public Library
The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).
Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.
Museum of Fine Arts
Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.
Museum of Science
The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.
This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.
Old North Church
The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.