The global law firm Jones Day is pleased to announce that Colleen Heisey has joined the Washington Office as a partner in the Health Care Practice. Formerly a partner in Hunton & Williams, LLP’s Washington office, Ms. Heisey focuses on food and drug law with a particular emphasis on advertising, promotion, and compliance counseling.
“We’re delighted that Colleen has chosen to join us and bring her vast experience in a highly dynamic regulatory arena to bear for our clients,” said Greg Shumaker, Partner-in-Charge of Jones Day’s Washington Office. “The many changes happening in the health care industry will have ripple effects in a variety of regulatory areas and her experience adds even more to our depth in providing a full complement of services to a variety of health care and life sciences clients.”
Ms. Heisey advises on regulatory and compliance issues for drug, biologic, food, dietary supplement, medical device, and cosmetic products, including product promotion and advertising, good manufacturing practice requirements, product recalls, FDA inspection, and warning letters. She has provided 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. Her legal support services for pharmaceutical advertising and promotional activities for drug, medical device, and food companies include ongoing review of product marketing materials and programs; real time monitoring and feedback of on-the-ground activities related to sales and marketing; regulatory and legal comments and direction in development of direct-to-consumer broadcast advertising; and audits of pharmaceutical and medical device company sales, marketing, and medical affairs activities, as well as drug sampling programs.
“Health care and life sciences companies are under increasing scrutiny from the FDA, USDA, and other federal and state regulatory agencies,” said James Dutro, the San Francisco based co-leader of Jones Day’s Health Care Practice. “Colleen’s deep understanding of the regulations and the regulators adds significantly to the formidable capabilities we have assembled to counsel clients worldwide on the evolving regulatory environment.”
Ms. Heisey is a graduate of Johns Hopkins University Bloomberg School of Public Health (Master of Public Health 2006), The George Washington University Law School (J.D. with honors 2002), and Lycoming College (B.S. in biology summa cum laude 1999).
