Colleen M. Heisey

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. [1]