Colleen M.Heisey

Partner

Washington + 1.202.879.3449

Connect:

Share

With more than 20 years of experience focused on Food and Drug Administration (FDA) regulated products, Colleen Heisey has a strong understanding of the legal, regulatory, and compliance issues facing drug, biologics, medical device/diagnostic, and food/dietary supplement clients. Her practice involves strategic counsel to clients navigating near-market and post-market opportunities and obligations, including matters related to product jurisdiction, pathways to market, regulatory exclusivities, accelerated approvals, orphan drug status, adverse event reporting, recalls, and managing federal agency inquiries and enforcement actions.

A business-oriented problem solver, Colleen evaluates and advises on product advertising and promotion and has helped life sciences companies launch dozens of prescription and over-the-counter (OTC) drug and device products. She has worked with regulated industries to develop and implement right-sized comprehensive compliance programs. Colleen's distinct skills and experiences are deployed to serve clients as they perform due diligence on products and targets and negotiate license, collaboration, acquisition, and other commercial agreements. She also supports robust teams in contract disputes and arbitration arising from commercial agreements involving regulated products and in litigation arising under the Federal Food, Drug, and Cosmetic Act (FDCA).

Colleen maintains an active presence in the Food and Drug Law Institute, speaking and writing for the organization, as well as serving on planning and products committees. As a first-generation college graduate, she is a proud member of the Board of Trustees of Lycoming College.

Experience

  • Sanofi to separate its consumer healthcare business, OpellaJones Day is acting as securities law counsel to Sanofi in the separation of Opella, its consumer healthcare business, and the announced sale of a 50% controlling stake.
  • Guardian Pharmacy Services completes $128.8 million IPO and pre-IPO corporate reorganizationJones Day represented Guardian Pharmacy Services, Inc., a leading long-term care pharmacy services company, in connection with its $128.8 million initial public offering (“IPO”) and pre-IPO corporate reorganization.
  • Patent owner successfully challenges FDA regulatory review determinationJones Day successfully represented a patent owner in challenging the U.S. Food and Drug Administration's (FDA) regulatory review period determination for its drug.
  • Kowa Pharmaceuticals America signs co-promotion agreement to promote Arcutis's ZORYVE®Jones Day represented Kowa Pharmaceuticals America, Inc. in connection with a co-promotion agreement with Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT).
  • STERIS sells dental segment to an affiliate of Peak Rock CapitalJones Day advised STERIS Plc in the $787.5 million sale of Dental segment to Peak Rock Capital, a leading middle-market private investment firm.
  • Direct lender provides $87 million senior secured credit facility to large private equity-backed provider of medical supplies to companies in commercial cruise and shipping industriesJones Day advised a direct lender, as administrative agent, collateral agent, sole lead arranger, and lender, in connection with a $87 million senior secured credit facility provided to a large private equity sponsored company that provides medical supplies to companies in the commercial cruise and shipping industries.
  • Shiseido Americas acquires Dr. Dennis Gross Skincare for $450 millionJones Day advised Shiseido Americas Corporation, a subsidiary of Shiseido Co., Ltd., in the acquisition of DDG Skincare Holdings LLC, the owner of Dr. Dennis Gross Skincare, for $450 million in cash.
  • EagleTree Capital acquires Summit Hill FoodsJones Day advised EagleTree Capital in the acquisition and financing of Summit Hill Foods, Inc., a leading branded food company producing nationally recognized, premium brands, including Better Than Bouillon and The Original Louisiana Hot Sauce.
  • Leading financial services company provides $380 million syndicated senior secured credit facility to global supplier of technologies for security, healthcare, and other industrial end-marketsJones Day represented a leading financial services company, as left lead arranger and administrative agent, in connection with a $380 million syndicated senior secured credit facility, consisting of a $340 million term loan and a $40 million revolving credit facility, provided to a leading global supplier of advanced imaging, power, and motion control technologies for security, healthcare, and other industrial end-markets.
  • Sumitomo acquires assets and rights related to lefamulin from NabrivaJones Day advised Sumitomo Pharma Co., Ltd. in the acquisition of assets from Nabriva Therapeutics plc and various wholly-owned subsidiaries. This acquisition includes assets from the U.S., Ireland, and Austria in support of the development, manufacture, marketing and commercialization of lefamulin in the People’s Republic of China, Hong Kong, Macau and Taiwan.
  • ONCAP sells medical division to BiomericsJones Day advised ONCAP in the sale by portfolio company Precision Concepts International of its medical division to Biomerics, a portfolio company of Wasatch Equity Partners.
  • Astellas acquires Iveric bioJones Day advised Astellas Pharma Inc. in the $5.9 billion cash acquisition of Iveric bio, Inc., a science-driven biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs.
  • Labcorp completes spin-off of FortreaJones Day represented Labcorp (NYSE: LH), a leading global life sciences company, in the spin-off of Fortrea, the newly formed independent Contract Research Organization providing Phase I-IV clinical trial management, market access and technology solutions to pharmaceutical and biotechnology organizations around the world.
  • Fortrea completes $570 million private placement of Senior Secured Notes and obtains $1.5 billion credit facilityJones Day represented Fortrea Holdings Inc., a leading global contract research organization (“CRO”) that provides comprehensive phase I through IV biopharmaceutical product and medical device services, patient access solutions and other enabling services, in connection with the Rule 144A and Regulation S offering of $570 million aggregate principal amount of 7.500% Senior Secured Notes due 2030 and a $1.5 billion senior secured credit facility as part of its spin-off from Laboratory Corporation of America Holdings.
  • Sky Island Capital acquires Kaufhold's KurdsJones Day represented Sky Island Capital in the acquisition and financing of Kaufhold's Kurd's, Inc., a wholesale food manufacturer that primarily sells direct to food service distributors across the United States.
  • UPL sells stake in Advanta Enterprises to KKRJones Day advised UPL Limited in its $300 million sale of a 13.33% stake in its subsidiary, Advanta Enterprises Limited, to KKR.
  • CDPQ leads $125 million Series D financing of Soli OrganicJones Day advised CDPQ as lead investor in the $125 million Series D financing of Soli Organic, the nation's only soil-based, indoor farming company delivering 100% USDA certified organic produce.
  • Riverside portfolio company acquires BloodHubJones Day represented The Riverside Company in connection with the acquisition and financing by portfolio company InVita Healthcare Technologies of BloodHub, a leading software provider of blood and biologics supply chain automation solutions.
  • Eurobio Scientific acquires GenDxJones Day advised Eurobio Scientific SA in the acquisition and financing of the Dutch company Genome Diagnostics BV (GenDx) from its founder and its shareholders for €135 million (net of adjusted cash).
  • STERIS sells renal business to EvoquaJones Day advised STERIS in the $196.3 million sale of its Renal Care business to Evoqua Water Technologies, a leading provider of mission-critical water and wastewater treatment solutions.
    • View All

    November 2024 Alert

    Inaugural Meeting for FDA's Digital Health Advisory Committee to Focus on GenAI-enabled Medical Devices

    November 2024 Reprint

    Patent Licensing (The Licensing Journal)

    NOVEMBER 2024 Alert

    FDA's New Human Foods Program: Enhancing Post-Market Safety Assessments of Chemicals in Food

    AUGUST 2024 Alert

    FDA Remote Regulatory Assessments Are Not So Remote Anymore

    June 2024 Alert

    FDA Launches the Center for Clinical Trial Innovation

    June 2024 Reprint

    Apter v. HHS: You are not a horse, and FDA is not a physician (FDLI Top Food & Drug Cases, 2023)

    May 2024 Commentary

    Canadian Drug Importation May Undermine Intellectual Property Protection

    April 2024 Commentary

    FTC Weighs In on Orange Book Listing of Drug-Device Patents

    April 2024 Alert

    FDA Proposes Updated Guidance Concerning Cybersecurity of Medical Devices

    March 2024 Alert

    FDA's Final Device Manufacturing Rule—Not Quite Harmonious With Status Quo

    View All

    Additional Publications

    • May 2022
      Are Your Labels Up to Date? Ensuring Compliance With the USDA’s National Bioengineered Food Disclosure Standard

    Additional Speaking Engagements

    • June 5, 2024
      Personal Care Branding: Advertising Issues, Challenges and Litigation Trends - 2024 and Beyond (PCPC, Legal & Regulatory Conference)
    • November 2023
      All Roads Lead to Compliance: Enforcement Trends from Agencies and Consumer Protection Organizations (FDLI, Advertising & Promotion for Medical Products Conference)
    • October 14, 2022
      Recent Trends in Enforcement and Practical Examples to Ensure Compliance (FDLI, Advertising and Promotion for Medical Products Conference)
    • March 16, 2022
      FDLI Careers Over Coffee March: Hiring Process Tips & Tricks (FDLI)
    • October 13, 2021
      Closed Doors Lead to Open Windows: Emerging Trends in Virtual Sales Force Tools (FDLI, Advertising and Promotion for Medical Products Conference)
    • September 29, 2021
      Exploring FDA’s Expedited Programs: Applicability and Eligibility (ACI’s 37th FDA Boot Camp: American Conference Institute)
    • February 4, 2021
      Fundamentals of Vaccine Regulation: Pathways to Market (FDLI)
    • October 28, 2020
      Practical Considerations for Successful Remote-Based Marketing and Compliance Strategies - Health Care Provider Access and Sales Training (FDLI, Advertising and Promotion for Medical Products Conference)
    • August 20, 2020
      How to Introduce Clients to the FDA-Regulated Space: A Sharing Session (FDLI, Law Over Lunch)
    • April 24, 2020
      Face Masks and Their Use in the Workplace (Original Equipment Suppliers Association)
    • January 2019
      Blockchain in Healthcare, New York State Bar Association Annual Meeting
    • December 4, 2018
      Drug Quality and Security Act, Title I – Inspections and Enforcement in the Compounding World (FDLI)
    • October 10, 2018
      Regulation of Medical Products in the EU and Combination Products (Drug Information Association)
    • May 4, 2016
      Compliance in the Precision Medicine Era: Legal Considerations for the Contemporary Life Sciences Industry
    • December 9-10, 2015
      Enforcement, Litigation, & Compliance The Food and Drug Law Institute (FDLI)
    • October 15-16, 2015
      ABA/MDMA/FDLI Medical Device Law 2015
    • October 1-2, 2015
      Advertising and Promotion for the Pharmaceutical, Medical Device, Biological, and Veterinary Medicine Industries, The Food and Drug Law Institute
    • July 16, 2015
      ABA's FDA Drug Law Fundamentals, Webinar
    • November 12, 2014
      ABA's Off-label Marketing and Free Speech: Caronia and the Future of Speech in Therapeutic Product Promotion webinar
    • September 10, 2014
      Presentation to Mansfield-PhRMA Fellows: How U.S. Law Firms Help Their Clients Bring Pharmaceuticals and Biologics to Market
    • May 18, 2014
      ATA Telemedicine Venture Summit 2014
    • May 6, 2014
      Executive Roundtable Series: New Frontiers in Health Care and Life Sciences; A Look at the Legal Implication
    • February 20, 2014
      The Digital Health Revolution: How Law is Shaping the Next Frontier in Health Care Delivery, Health Law and Justice Society
    • November 13, 2013
      2013-2014 Life Sciences Webinar Series: Intellectual Property, Regulatory, and Antitrust Issues in Life Sciences M&A and Capital Markets Transactions
    • October 24, 2013
      FDA Fundamentals: FDA Drug Approval and Oversight, American Bar Association
    • September 11, 2013
      Healthcare Technology Approvals, Clearances and Commercialization, Angel Venture Forum’s Cyber Security & Healthcare Investment Conference
    • August 1, 2013
      Successfully Navigating FDA Citizen Petitions and Responses

    Before sending, please note:

    Information on www.jonesday.com is for general use and is not legal advice. The mailing of this email is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Anything that you send to anyone at our Firm will not be confidential or privileged unless we have agreed to represent you. If you send this email, you confirm that you have read and understand this notice.