Advertising & Promotion of Drugs Part II (Update)

(265 Ratings)

Produced on: February 14, 2017

Course Format On Demand Audio

Taught by

Categories:

Course Description

Time 64 minutes
Difficulty Intermediate

Scientific innovation and business concerns can easily become entangled in the U.S. regulatory framework for the pre-approval promotion of drug and medical devices. Once drugs and devices have been approved, however, promotional-related compliance concerns do not become any less complex.

The second course in this three-part series, led by attorney Dominck DiSabatino and regulatory expert Jennifer Stohlmann, examines three important areas of drug and medical device law in the United States: pre-approval promotion, direct to consumer advertising, and off-label promotion.

Learning Objectives: 

  1. Understand pre-approval promotion
  2. Examine the legal restrictions on what can be said in the pre-approval stage

  3. Discuss the FDA & SEC Partnership

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

JB
Jessica B.

Good continuation of the subject

MT
Maeve T.

Excellent!

JM
Jonah M.

great team

AG
Amy G.

They presenters seemed very dutiful.

LT
Lynne T.

Thank you!

WS
William S.

Great course. Thank you!

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