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.
Examine the legal restrictions on what can be said in the pre-approval stage
Discuss the FDA & SEC Partnership
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.
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.
George Washington University Law School, J.D., 2012, with honors
Bucknell University, B.S., 2008
New York, 2013
United States Patent and Trademark Office, 2009
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.
Excellent presentation. Very useful analyses.
Maybe the best course / series I’ve listened to on Lawline
Continue to hold my interest.
Another excellent course
Good continuation of the subject
They presenters seemed very dutiful.
Great course. Thank you!