Dominick P. DiSabatino

Dominick DiSabatino is a partner on the Life Sciences team in the firm's Washington, D.C. office.

Areas of Practice

Dominick’s practice focuses on complex FDA and healthcare regulatory, compliance and legal matters in the life sciences industry. Drawing from in-house secondments with clients of various growth stages, Dominick counsels pharmaceutical, biotechnology, cosmetics and medical device companies on critical business decisions spanning the entire product life cycle, from research and development to product launch and commercialization.

Dominick offers clients a deep knowledge of advertising and promotion of FDA-regulated products, organizational OIG compliance programs, labeling review and approval strategies, managed markets and payer interactions and privacy/data security concerns. He also advises his clients on matters regarding commercial contracting and supply chain logistics, clinical trial agreements, federal transparency obligations and interactions with FDA such as post-market adverse event and product complaint reporting, facility inspections and Form 483s. With his background in intellectual property law, Dominick identifies client issues related to patents, trademarks, copyrights and trade secrets.

Dominick is committed to pro bono service. He has counseled nonprofit organizations focused on health care integration and optimization and post-incarceration reentry programs. He also represented New York City's senior citizens in housing disputes and provided free speech advice for press operations in Africa.

Articles

FDA Law Blog

• "Withdrawal of Drug Approval Highlights Risk of Accelerated Approval Pathway," April 26, 2023
• "FDA To Require Demonstration of Cybersecurity Safeguards for Pre-Market Submissions of Certain Medical Devices," April 10, 2023
• "FDA Issues First Untitled Letter of the Year to HCT/P Manufacturer," March 29, 2023
• "OIG Advisory Opinion Alert: Medical Flights for Patient Access," March 7, 2023
• "FDA Issues Warning Letter to RightEye, LLC For Misbranding and Adulteration," February 13, 2023
• "FDA Lightens Promotional Restrictions for Certain COVID-19 Drugs with Emergency Use Authorization," November 30, 2022

• "Pharmaceutical Manufacturers Ask EDVa to Allow Cost-Sharing Under the AKS," November 21, 2022
• "OIG Limits Pharmaceutical Manufacturers’ Ability to Offer Drug Cost-Sharing Subsidies," October 13, 2022
• "Biogen Settlement Summary," October 6, 2022
• "Charging for Investigational Drugs Under an IND Questions and Answers, Draft Guidance for Industry, August 2022," August 31, 2022
• "FDA Issues Final Guidance on Drug and Biological Instructions for Use (IFU)," July 21, 2022
• "FDA Issues Untitled Letter to Althera Pharmaceuticals for Statements Relating to ROSZET®," June 23, 2022
• "FDA Issues Untitled Letter to Bausch Health Companies for Misleading Statements Relating to DUOBRII™," April 19, 2022
• "OIG Advisory Opinion Alert: Yet Another Favorable Decision for Medical Device Manufacturers," March 17, 2022
• "FDA Issues Untitled Letter to Althera Pharmaceuticals for Statements Relating to ROSZET®," June 23, 2022

Healthcare Law Blog Posts

• "CMS Releases Guidance on Implementation of Rebate Programs for Certain Medicare Part B and Part D Drugs," February 22, 2023

Speaking Engagements

• Speaker, "Pharmaceutical Compliance Congress 2023," April 25 - 27, 2023

Events