Update on the Advertising and Promotion of Pharmaceuticals, Medical Device, Biologics and Veterinary Medicine Industries
Steve Gracey just returned from the Food and Drug Law Institute’s yearly conference on advertising and promotion for the pharmaceutical, medical device, biologics and veterinary medicine industries. This conference contained multiple panels of top level FDA officials and industry representatives on topics such as Direct-to-Consumer advertising (“DTC”), state and institutional challenges to physician marketing, proposed legislation requiring Risk Evaluation and Mitigation Strategy (“REMS”), regulation by the U.S. Department of Justice and Office of the Inspector General, sales force and medical science liaison practices and marketing and working with the FDA.
One of the topics receiving a lot of attention and focus was DTC. Many top level FDA officials gave informal feedback on their views of compliance with DTC regulations. Additionally, the FDA discussed in great detail the latest version of the Prescription Drug User Fee Act (“PDUFA IV”) that was signed by President Bush on September 27, 2007. Although a company is not required to obtain FDA pre-approval prior to using DTC or any other promotional or advertising materials, PDUFA IV creates a program that give companies, for a defined cost, the benefit of timely FDA input on whether its television DTC is accurate, balanced and adequately supported before public dissemination. This program has the potential to be a great benefit to companies to timely plan television DTC campaigns and minimize the financial risk of subsequent FDA corrective action.
Another topic of much discussion was the increasing scrutiny on practices of company sales force and medical science liaisons for promotion to physicians or other healthcare practitioners, including off-label promotion of products. The distinction between appropriate and inappropriate promotion of a product and what a sales force and medical science liaison can and cannot do when discussing a product is getting grayer. More disconcerting is the fact that as this practice becomes grayer, more state and federal lawsuits are being filed to re-collect money paid by state and federal healthcare programs for off-label prescribing when there appears to be some aspect of off-label promotion leading to the increased prescribing. Not only could a company have to pay hundreds of millions in restitution, but company officials risk criminal prosecutions and the company could be excluded from state and federal health care programs costing the company even more money.
What was clear from the conference and statements from the FDA officials and industry representatives is that the landscape for promotion and advertising for these products is greatly changing and the regulation of the promotion and advertising has become a high priority for the FDA. As several officials stated, “public safety is the number one priority of the FDA,” and advertising and promotion of these products has the potential to greatly impact the public safety. But, at the same time that it is increasing its scrutiny, the FDA is attempting to create resources and programs so companies can ensure compliance with promotion and advertising requirements. Companies need to learn about and take advantage of these resources and properly plan the advertising and promotion of their products to ensure increased revenue while minimizing the risk of FDA corrective action, or worse, federal or state civil or criminal actions.