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.
FDA Regulatory and Compliance
Advertising and Promotions
Marketing and Advertising Regulatory
Health and Wellness Marketing Compliance
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.
Author, State Venture Capital Funds: Analyzing the InvestMaryland Program, State Tax Notes (2012)
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, RAC is a regulatory specialist whose expertise spans the complete product lifecycle for prescription and over-the-counter human and animal drugs, biologics, and devices. As a member of Loeb & Loeb’s FDA Regulatory & Compliance team, she has up-to-date knowledge of a wide range of FDA and FTC guidance documents and has performed extensive analyses of FDA, OIG and DOJ enforcement activity related to the commercialization of FDA-regulated products.
Ms. Stohlmann fosters a culture of compliance and translates formal Compliance Programs into compliant day-to-day activities. Her experience extends from detailed legal research and drafting of policies to operationalization and system implementation in the live business environment. She performs compliance management of commercial system vendors and 3PLs and participates on commercial product launch teams. Ms. Stohlmann crafts compliance trainings for home office personnel, field forces, and vendors on topics ranging from prescription drug sampling to speaker programs to medical communications.
Ms. Stohlmann 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.
Ms. Stohlmann was previously with Porzio, Bromberg, and Newman P.C., and select examples of her work experience include the following:
Completion and submission of formal communications, regulatory filings, and reports to Federal and State agencies.
Preparation of required disclosure logs under an OIG Corporate Integrity Agreement.
Performance of gap analyses and remediation of audit deficiencies.
Researching standards of substantiation and required disclosures for specific product claims for drugs, medical devices, cosmetics, and dietary supplements in support of commercial and regulatory strategies.
Surveying state laws and regulations in areas of rapid legislative change, such as: manufacturer/distributor/wholesaler licensing, pharmaceutical marketing and advertising disclosure requirements, and midlevel prescriber licensing.
Support of legal-medical-regulatory review processes for scientific and promotional materials.
Completion of regulatory due diligence for life sciences transactions.
Member, Regulatory Affairs Professional Society
Author, FDA Regulatory and Compliance Monthly Recap — October 2016 (October 2016)
Author, FDA Regulatory and Compliance Monthly Recap — September 2016 (September 2016)
Author, FDA Regulatory and Compliance Monthly Recap — August 2016 (August 2016)
Author, FDA Regulatory and Compliance Monthly Recap — July 2016 (July 2016)
Author, FDA Regulatory and Compliance Monthly Recap – June 2016 (June 2016)
Author, FDA Regulatory and Compliance Monthly Recap – May 2016 (May 2016)
Author, FDA Regulatory and Compliance Monthly Recap — April 2016 (April 2016)
Author, FDA Regulatory and Compliance Monthly Recap — March 2016 (March 2016)
Author, FDA Regulatory and Compliance Monthly Recap — February 2016 (February 2016)
Regulatory Affairs Certification Board, Regulatory Affairs Certification (United States)
Regulatory Affairs Professional Society, Regulatory Affairs Certificate Program, Medical Devices and Pharmaceuticals (Dual)
Pratt Institute, B.F.A. in Writing
President's List, Department Honor for Academic Excellence
They presenters seemed very dutiful.
Great course. Thank you!
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