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

  • Parker Products invests in Creative Food IngredientsJones Day advised Parker Products, LLC, a portfolio company of The Riverside Company, in the acquisition and financing 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.
  • 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.
  • Major American manufacturer reviews PREP Act immunityJones Day advised a major American manufacturer during the COVID-19 pandemic on obtaining immunity from liability for the manufacture and distribution of covered countermeasures under the Public Readiness and Emergency Preparedness Act (PREP Act).
  • Riverside acquires National FlavorsJones Day represented The Riverside Company in connection with its acquisition of National Flavors LLC, a Michigan limited liability company engaged in the business of formulating and producing artificial and natural liquid flavors, extracts, variegates and colors for frozen desserts and dairy products, baked goods, confections, processed fruits, beverages, and other product categories.
  • Blue Sea Capital acquires Innovative FlexPakJones Day advised Blue Sea Capital in its acquisition and related financing of Innovative FlexPak, a developer, formulator, and provider of single-serve and multi-dose ingestible health and wellness products for leading brands.
  • Toyota Tsusho sold shares in Country Pure Foods, Inc. to BPCP CPF Holdings Inc.Jones Day represented Toyota Tsusho America, Inc. and Sapporo Holdings Limited in the sale of all of the outstanding stock of Country Pure Foods, Inc. to a portfolio company of Blue Point Capital Partners.
  • Biotechnology company persuades FDA to lift clinical hold on experimental gene therapyJones Day represented a biotechnology company in a lawsuit against the Food and Drug Administration (FDA) for placing a clinical hold on the company’s experimental gene therapy.
  • Shore Capital Partners portfolio company acquires MD Resource CorpJones Day represented Shore Capital Partners LLC in connection with the acquisition by portfolio company Innovia Medical of Medical Device Resource Corporation, a manufacturer and distributor of liposuction and fat transfer systems for the plastic and cosmetic surgery markets.
  • Cortec Group sells WU Holdco to The Carlyle Group and TA AssociatesJones Day advised the Cortec Group in the sale of WU Holdco, Inc., the holding company for Weiman Products, LLC and Urnex Brands, LLC, which are leading developers, manufacturers, and distributors of specialty cleaning products for the consumer and commercial markets, to The Carlyle Group and TA Associates.
  • IZI Medical Products acquires soft tissue biopsy and breast localization needle assets from Cook MedicalJones Day represented Shore Capital Partners, LLC in connection with the acquisition by portfolio company, IZI Medical Products, LLC, of select soft tissue biopsy and breast localization needle assets from Cook Medical.
  • 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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