Advertising & Promotion of Drugs Part I (Update)

(446 Ratings)

Produced on: February 14, 2017

Course Format On Demand Audio

Taught by

Categories:

Course Description

Time 93 minutes
Difficulty Intermediate

The first course of this three-part series, led by attorney Dominck DiSabatino and regulatory expert Jennifer Stohlmann, begins to navigate the complicated and ambiguous world of drug and medical device promotion in the United States.

This session provides historical context and overviews of the relevant agencies and laws, including the Food Drug & Cosmetic Act and Federal Trade Commission Act. It also breaks down the main elements of compliant advertising and promotion and highlight trends in enforcement activity that provide valuable insight into regulators' current thinking.

Learning Objectives: 

  1. Understand the historical context of relevant agencies and laws
  2. Determine who has jurisdiction, the FDA or the FTC
  3. Identify the main elements of compliant advertising
  4. Highlight recent trends in enforcement activity 

Faculty

Dominick DiSabatino

Loeb & Loeb LLP

Dominick DiSabatino’s practice involves counseling pharmaceutical, biotechnology and medical device companies on a variety of corporate regulatory and compliance-related issues. He assists his life sciences clients in making decisions informed by a thorough understanding of federal and state laws, as well as industry-specific best practices. Mr. DiSabatino’s expertise spans the entire product lifecycle, from clinical trial registration and device classification strategies to product launches, post-market adverse event reporting and FDA correspondence.

Mr. DiSabatino’s experience covers industry-critical regulatory and compliance concerns, including: global interactions with healthcare providers; global clinical trial recruitment; global anti-kickback, anti-bribery, and anti-corruption; PDMA compliance; CMS provider data; transparency reporting and disclosures; labeling, advertising, promotion, and scientific review; post-market adverse event and product complaint reporting; management of recalls, prohibitions, warning letters, and Form 483s; environmental hazard regulations; trademark, copyright, and trade secrets;. corporate due diligence; privacy; and contracting.

Mr. DiSabatino also remains involved in industry education, serving as Co-Chair of MedTech Metro’s RA/QS Group, and prepares informative publications, such as a textbook chapter on the evolving implementation of the Sunshine Act.

Mr. DiSabatino is further committed to pro bono service. He has provided guidance for 501(c)(3) nonprofit organization, representation of senior citizens in New York City housing disputes and first amendment advice for press operations in Africa.

Practice Areas

  • FDA Regulatory and Compliance
  • Life Sciences
  • Healthcare
  • Advertising and Promotions
  • Marketing and Advertising Regulatory
  • Health and Wellness Marketing Compliance
  • Corporate

Prior Experience

Prior to joining Loeb & Loeb LLP, Mr. DiSabatino was an associate at Paul Hastings, LLP, where he focused his practice on life sciences patent and regulatory matters. Prior to practicing law, Mr. DiSabatino participated in research projects and developed prototypes for organizations in the healthcare industry.

Publications

  • Author, State Venture Capital Funds: Analyzing the InvestMaryland Program, State Tax Notes (2012)

Education

George Washington University Law School, J.D., 2012, with honors

Bucknell University, B.S., 2008

Bar Admissions

New York, 2013

United States Patent and Trademark Office, 2009




Jennifer Stohlmann

Loeb & Loeb LLP

Jenny Stohlmann is an RAC-certified regulatory specialist whose expertise spans the complete product life cycle for prescription and over-the-counter human and animal drugs, biologics and medical devices. She possesses deep knowledge of the latest FDA and FTC guidelines across a wide range of industry-critical issues, and she has performed extensive analyses of FDA, OIG and DOJ enforcement activity related to the commercialization of FDA-regulated products. 

Jenny works with organizations to foster a culture of compliance that incorporates formal programs and translates them to compliant daily activities. Her experience ranges from detailed legal research and drafting of policies to operations and systems implementation in the live business environment. 

She performs compliance management of commercial system vendors and 3PLs and participates on commercial product launch teams. In addition, Jenny crafts compliance trainings for clients’ home office personnel, field forces and vendors on topics ranging from prescription drug sampling to speaker programs to medical communications. 

Over the course of her career, Jenny has demonstrated knowledge of the regulatory and compliance obligations of manufacturers and distributors under FDCA, PDMA, User Fee Acts, FDAMA, FDAAA, FDASIA, PPACA and Title 21 of the Code of Federal Regulations.

Reviews

JG
Jason G.

Comprehensive survey of the topic.

MS
Michael S.

Great

JB
Jessica B.

Good program with lots of specifics

MP
Mary P.

I look forward to Parts II & III.

PM
Peter M.

Excellent Presentation

HJ
Hilary J.

Was easy to follow

Load More

$89

$ 89 Health Care Law and Science & Technology Law In Stock

Accreditation

Get Unlimited Access to Lawline Courses

Unlimited CLE Subscription gives you access to take almost any course from our catalog and earn as much CLE credit as you need.