As 21st century medical and technological innovation gain momentum, the FDA and FTC race to keep up. In the final segment of the three-part series, the focus will be on regulatory and compliance changes surrounding flashpoints like the use of social media and press releases in an era when non-experts use digital technology to report ahead of the official news cycle.
The third and final course in this series, led by attorney Dominck DiSabatino and regulatory expert Jennifer Stohlmann, will update participants on hot topics in the expanding burden of compliance while outlining classes of exempt communications.
Identify the compliance regulations applying to communications with the consumer
Address the tension between the regulatory bodies
Discuss the two major types of exempt communication, help-seeking/disease awareness ads and scientific exchange
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.
Three fine presentations.
A solid intro.
Nice back and forth dialogue.
Continuation of a good program
This 3-part program was informative and very good.
Very good program!
Very nice presenters!
Another fine program. Thank you!