Life Sciences Attorneys Co-Author FDLI Update Article on Pharmaceutical Companies’ Communications with Health Care Payers
In an article published in the September/October issue of the Food and Drug Law Institute (FDLI) Update magazine, life sciences counsel Kellie Combs (Washington, D.C.) address the challenges that the FDA regulatory scheme presents for pharmaceutical companies that want to share information about their products with health care payers. As health care spending continues to rise, there is more pressure than ever on payers to control costs. Pharmaceutical companies’ communications therefore play an important role in ensuring that payers have accurate and up-to-date information on which to base coverage decisions.
The author explains that the types of information that payers need frequently do not align with the information FDA has traditionally permitted drug manufacturers to share. Kellie argues that the FDA’s regulatory scheme governing manufacturers’ speech is unduly restrictive and ambiguous, leaving drug makers in a difficult predicament, compromising the ability of payers to make timely and well-informed decisions, and severely impacting patient care. Because the regulatory framework is unclear, unworkable, and subject to constitutional challenge, the co-authors conclude that the time has come for meaningful reform. (Article reprinted with permission from FDLI)