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.

Honors

Top Author, JD Supra Readers' Choice Awards, 2024-2025

Rising Star, FDA: Pharmaceutical, LMG Life Sciences, 2023-2024

"Ones to Watch," Best Lawyers, 2024

Articles

FDA Law Blog

• "LDT Final Rule Series: Part 4 – Rule Overturned by Federal District Court," April 7, 2025
• "Reminder: FDA Does, In Fact, Review DOF," March 11, 2025
• "Finally, FDA’s Final Word on Unapproved Use Communications," February 7, 2025
• "FDA Dumps Trio of Device-Related Guidances Prior to Administration Change," January 27, 2025
• "FDA Furthers Efforts to Improve the Accelerated Approval Pathway through New Draft Guidance on Confirmatory Trials," January 14, 2025
• "New Accelerated Approval Guidance Underscores Need for Accountability," December 19, 2024

• "LDT Final Rule Series: Part 3 – Legal Challenges," December 16, 2024

• "FDA Releases Long-Anticipated Guidance on Predetermined Change Control Plans for Devices That Utilize AI/ML Software," December 5, 2024
• "Key Takeaways from FDA’s Latest Social Media Warnings," December 5, 2024
• "DOJ Updates Guidance on Evaluation of Corporate Compliance Programs," October 29, 2024
• "Ubrelvy Untitled Letter – A Double Fault for AbbVie? Or Makeup Misread for FDA?," September 17, 2024
• "Krazati Untitled Letter: A Cautionary Tale for CFL Promotion of Accelerated Approval Drugs," August 14, 2024
• "FDA’s Second Untitled Letter of the Year – An Apparently Tough Choice Between Raising Awareness and Public Safety for Anaphylaxis Drugs," July 30, 2024
• "FDA Revisits and Updates Guidance on Addressing Misinformation – Ten Years Later," July 16, 2024

• "LDT Final Rule Series: Part 2 – Response to the Rule," June 6, 2024
• "FDA Gets Technical on HCT/P Rules in Warning Letter to Human Tissue Company," May 31, 2024

• "OIG Issues Favorable Advisory Opinion Regarding Patient Assistance Funds," May 8, 2024
• "LDT Final Rule Series: Part 1 – Rule Overview," April 30, 2024
• "FDA Warning Letter Regulates 'Research Only' Labels," April 24, 2024

• "Time to Refresh? FDA Issues Draft Guidance on Key Information and Informed Consent," March 19, 2024
• "Oregon Prescription Drug Price Transparency Act in Limbo," March 8, 2024
• "FDA’s Office of Prescription Drug Promotion Issues Its First Untitled Letter of the Year to Novartis for Misleading Statement Relating to KISQALI®," February 2, 2024
• "OIG Permits Medical Device Manufacturer’s Cost-Sharing Subsidies for Medicare Beneficiaries in Clinical Trial," January 30, 2024

• "2024 Top-of-Mind Issues for Life Sciences Companies," January 25, 2024

• "FDA Issues Final Rule and Guidance on Direct-To-Consumer Prescription Drug Advertisements," January 18, 2024
• "From Good Reprint Practices to SIUU Communications: What Firms Need to Know," November 10, 2023

• "OIG General Compliance Program Guidance November 2023," November 8, 2023

• "FDA’s Proposed Rule on LDT Regulation and the Debate over Agency Deference," October 18, 2023
• "FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software," September 26, 2023
• "Context is Key: FDA Sends a Strong Message About Efficacy Claims," September 7, 2023
• "FDA’s Office of Prescription Drug Promotion Issues Second Untitled Letter of the Year to Exeltis for Misleading Statements Relating to SLYND®," August 25, 2023
• "FDA Approves First Over-the-Counter Daily Oral Contraceptive," August 3, 2023
• "FDA Maintains Focus on “Intended Use” for Software-Enabled Medical Devices," July 26, 2023
• "FDA Issues First Untitled Letter of the Year to Xeris Pharmaceuticals," June 15, 2023
• "DOJ Continues to Discuss Updates to Compliance Program Guidance and Corporate Enforcement Policies," June 15, 2023
• "FDA Issues Proposed Rule for Standardized and Accessible Patient Medication Information," June 13, 2023
• "FDA Clarifies Approach to Pediatric Drug Development," June 5, 2023
• "FDA Cracking Down on Unapproved HCT/Ps with Fourth Untitled Letter of 2023," June 2, 2023
• "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

• "Connecticut Follows in the Footsteps of Other Jurisdictions Requiring Registration of Pharmaceutical Representatives," October 25, 2023

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

Speaking Engagements

• Speaker, "Introduction to Advertising and Promotion for Medical Products," Food & Drug Law Institute, October 16, 2024
• Speaker, "Pharmaceutical Compliance Congress 2023," April 25 - 27, 2023

Events