Colleen M.Heisey

Partner

Washington + 1.202.879.3449

Colleen Heisey's practice focuses on food and drug law with a particular emphasis on product promotion and advertising, compliance counseling, good manufacturing practice requirements, product recalls, FDA inspection, competitor issues, and enforcement actions. She has advised on issues surrounding the regulation of drug, biological, food, dietary supplement, medical device, and cosmetic products by the FDA, USDA, and other federal and state agencies.

Colleen has substantial experience with regulatory oversight and compliance assessment for due diligence audits of drug, medical device, and food companies, including those related to product safety, product labeling, product marketing and advertising, and consumer complaints. She regularly provides legal support for pharmaceutical and device advertising and promotional activities, sales and marketing, and development of practitioner-oriented and direct-to-consumer print and broadcast advertising. Colleen has conducted audits and inspections of pharmaceutical and medical device company policies, procedures, and programs, including drug sampling, adverse event reporting, medical information management, and unsolicited requests. She has advised clients regarding matters related to the False Claims Act and Anti-Kickback Statute, reviewed and commented on strength of clinical trial designs in drug and device development and as potential support of product marketing, and has assessed proposed brand names for drug products in development for potential claims and product confusion, including appraisal of drug name similarity reports by third-party vendors. She has worked with regulated industry to develop and implement comprehensive regulatory compliance programs.

Colleen has written extensively on the food and drug industry.

Experience

  • TD Securities provides $450 million acquisition financing to Whole Earth Brands, Inc.Jones Day advised TD Securities (USA) LLC, as arranger, in connection with the refinancing of a previous credit facility to include a $450 million senior secured credit facility comprised of a $375 million term loan and a $75 million revolving credit facility to Whole Earth Brands, Inc., a leading global manufacturer of natural, plant-based, clean label, and zero or low-calorie sweeteners.
  • STERIS to acquire Cantel Medical for $3.6 billionJones Day is advising STERIS plc in its acquisition of Cantel Medical Corp, a global provider of infection prevention products and services primarily to endoscopy and dental customers, for $3.6 billion.
  • American Pacific Group acquires Eu NaturalJones Day advised American Pacific Group in the acquisition of Eu Natural, a provider of vitamin and mineral nutritional supplement products.
  • Morgan Stanley Capital Partners invests in AWT Labels & Packing and Citation Healthcare LabelsJones Day advised Morgan Stanley Capital Partners in their investment in Advanced Web Technologies Holding Company, which operates as AWT Labels & Packaging and Citation Healthcare Labels, from Mason Wells, a Midwest-based private equity firm.
  • Nanobiotix completes $113.3 million IPO on NasdaqJones Day represented Nanobiotix S.A., a French clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, in connection with its $113.3 million initial public offering in the United States and listing on Nasdaq.
  • Micreos teams up with L'Oréal for skin care products containing endolysinsJones Day represented Micreos Human Health B.V. in its license out to L'Oréal of endolysin technology that targets harmful skin bacteria while preserving useful bacteria for L'Oréal's use worldwide in skin care products for cosmetic applications.
  • Riverside portfolio company acquires INVIVO CommunicationsJones Day represented The Riverside Company in connection with the acquisition and financing by portfolio company Red Nucleus of INVIVO Communications, a Toronto-based digital scientific communications provider strategically focused on the medical affairs space.
  • Riverside portfolio company acquires Parker Products, LLCJones Day represented The Riverside Company in connection with the acquisition and financing by portfolio company Parker Products, LLC of Creative Food Ingredients, Inc., a provider of baked food ingredients and inclusions.
  • Sotera Health acquires Canadian-based Iotron IndustriesJones Day advised Sotera Health in the acquisition of Canadian-based Iotron Industries, a global leader in electron-based sterilization and materials modifications.
  • TD Securities arranges $190 million acquisition financing for Whole Earth Brands, Inc.Jones Day advised TD Securities (USA) LLC, as arranger, in connection with a $190 million senior secured credit facility comprised of a $140 million term loan and a $50 million revolving credit facility to Whole Earth Brands, Inc, a special purpose acquisition company (SPAC).
  • Riverside invests in GSB & Associates, Inc.Jones Day represented The Riverside Company in connection with its investment in GSB & Associates, Inc., a flavor house specializing in custom flavor development with a diverse portfolio of liquid and powdered flavors.
  • Digital health company expands telehealth programming in response to the COVID-19 public health crisisJones Day represented a digital health company in the expansion of their telehealth programming in response to the COVID-19 public health crisis.
  • National diagnostic clinician network expands telehealth programming in response to COVID-19 public health crisisJones Day represented a national diagnostic clinician network in their expansion of telehealth programming in response to the COVID-19 public health crisis.
  • Telehealth company expands programming in response to COVID-19 public health crisisJones Day represented a telehealth company in the expansion of their telehealth programming in response to the COVID-19 public health crisis and related health regulatory and contracting matters.
  • Telemedicine provider expands telehealth programming in response to COVID-19 public health crisisJones Day represented a telemedicine provider in their expansion of telehealth programming in response to the COVID-19 public health crisis.
  • Integer Holdings Corporation develops employee programming to mitigate the spread of COVID-19 within the workplaceJones Day represented Integer Holdings Corporation during the COVID-19 crisis to develop appropriate protocols and policies for implementing an employee temperature screening program, a face covering program, and return to work policies for employees suffering from COVID-19, respiratory illness, or exposure to individuals with COVID-19.
  • Large critical infrastructure employer considers implementing COVID-19 testing program for employeesJones Day represented a large critical infrastructure employer during the COVID-19 crisis to consider and assess appropriate protocols and policies for implementing an employee COVID-19 testing program at its sites. This included counseling on myriad federal, state, and local legal and regulatory frameworks as well as forming appropriate partnerships.
  • Power management company manufactures and distributes PPE during COVID-19 pandemicJones Day advised a power management company on regulatory and other issues related to manufacturing face masks for distribution to facilities and personnel in multiple jurisdictions including U.S., China, Taiwan, Japan, Australia/New Zealand, European Union, and Latin America.
  • GM partners with Ventec to manufacture ventilators in response to coronavirus pandemicJones Day is advising General Motors Company on the "Project V" partnership with Ventec Life Systems Inc. to mass produce ventilators needed to battle the coronavirus pandemic.
  • Medical equipment company responds to U.S. federal RFI, develops global strategy for responding to requests for specialized medical equipment in response to COVID-19 pandemicJones Day advised a medical equipment company in their response to a U.S. federal RFI for specialized medical equipment in response to the COVID-19 pandemic, in development of a global strategy regarding response to multiple state and country requests for specialized medical equipment, and in related antitrust and regulatory issues.
  • Speaking Engagements

    • January 2019
      Blockchain in Healthcare, New York State Bar Association Annual Meeting
    • 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
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