FDA’s rules governing the advertising and promotion of medical products are complex. Sometimes, the review of promotional material may seem to be more art than science. But the repercussions for getting it wrong can be severe – and not just from FDA. State attorneys general, the Federal Trade Commission, the Office of Inspector General (OIG), and private litigants all can take action against promotional activities that fail to comply with required standards. Companies thus need robust internal processes to ensure that their promotional activities are designed to achieve the company’s business objectives without undue risk.
Scott Lassman has broad experience working with companies on promotional issues. For example, Scott has served on the Promotional Review Committees (PRCs) of several small, mid-size and large drug companies, reviewing advertising and promotional labeling for prescription drugs in the cardiovascular, neurological, infectious disease and radiopharmaceutical areas, among others. From this in-house experience, Scott understands that companies are looking for practical advice that not only reduces regulatory risks but also advances important business objectives. This can be a delicate balance, but Scott has found it is almost always achievable with a little creative thinking.
Scott also routinely advises companies on First Amendment issues. He recently used First Amendment arguments to help a pharmaceutical company client obtain a letter from FDA confirming that the Agency would not object to the company’s marketing of clinical data about an “off-label” use. This allowed the company to affirmatively promote clinical data that was not on the approved labeling because of an exclusivity block.
Finally, Scott has deep expertise in the PhRMA Code and other voluntary marketing codes. In fact, he has been instrumental in drafting and revising national and international marketing codes governing the pharmaceutical and infant formula industries, including the PhRMA Code, the IFPMA Code and the IFM Marketing Code. Further, he served as one of the inaugural members of the IFPMA Code Compliance Network.
You are invited to contact Lassman Law+Policy for more information on the firm's counsel and advocacy in medical product advertising and promotion.