Tracy L. Acker
Tracy L. Acker brings to Reed Smith 10 years of experience in the FDA regulation of product marketing and advertising, both from inside the FDA and private industry. Between 1995 and 2000, Tracy mastered the intricacies of drug marketing regulation in the heart of the FDA, where she served as a Branch Chief for the Division of Drug Marketing, Advertising, and Communications (DDMAC). Part of her responsibilities included direction and supervision of regulatory review officers in the evaluation of advertising and promotional materials for prescription drug products.
From 2000 until joining Reed Smith in 2004, Tracy served as an FDA Liaison for Johnson & Johnson, as well as Director of Regulatory Affairs for Advertising and Promotion for J&J. She handled direct strategic and tactical regulatory counsel for sales and marketing activities, and advised senior management on compliance strategies for marketing and medical affairs communications.
Tracy's unique mix of high-level government and industry experience supports Reed Smith's Life Science clients by offering expert review of promotional labeling and advertising materials for drug, biological product, and medical device clients. As a pharmacist and former federal regulator, Tracy further expands the existing capacity of the firm's FDA practice by providing thorough and sophisticated regulatory consultations on a wide variety of marketing activities and technical materials, including those discussing clinical development of investigational products and new uses of approved products within the practice of medicine. Tracy also has extensive teaching experience and provides personalized advertising and marketing training for every company that promotes (or hopes to promote) an FDA-regulated product.
In 1987, Tracy received a B.S. in biology from the University of Michigan College of Literature, Science & Arts, and in 1993 earned a Doctor of Pharmacy from the University of Michigan College of Pharmacy.
Tracy is a registered pharmacist in Michigan and Maryland. She is a frequent speaker at Drug Information Association workshops on topics of regulation of prescription drug advertising, and drug manufacturers' provision of medical information.
Thoughts on Advertising: The advertising of prescription drugs, biologics and medical devices is a fascinating and complex area. In my opinion, it involves the unique intersection of medicine, business, public policy, ethics and politics. Because all of these factors must be considered, it can be difficult and unpredictable terrain to navigate. It really has become a specialty, particularly as the consequences of noncompliance have increased over the last few years. FDA is no longer the only government agency active in regulation, with the Department of Health and Human Services Office of the Inspector General alleging violations of the False Claims Act and anti-kickback statutes. I've seen companies, large and small, overhaul their compliance programs in response to the changing regulatory and legal environment. Staying on top of the changing environment and understanding the subtleties is key for both pharma and medical device companies.
I've worked in this area for 10 years, and have participated on all sides of these issues. As a pharmacist I have been a consumer of advertising messages. I have an insiders view of FDA regulation from working in DDMAC, and I understand the business needs from being in house in a large pharmaceutical company. I bring all these perspectives to my work in helping companies avoid compliance problems while still getting business done in a way that improves communications to physicians and consumers.