Allergan is suing the FDA on free speech grounds. The company wants to ability to provide information on off-label uses of Botox to physicians. FDA regulations allow promotion only for FDA approved indications. Physicians, however, can prescribe medications for any use they see fit. Allergan wants to fill the information gap that exists today. Those that oppose that view off-label promotion believe that the drug industry will have no incentive to test their drugs for new indications once the medication is approved, would over-promote their medicines and would hinder the FDA’s ability to protect human health.
Natasha Singer wrote a good overview of the story in the October 3, 2009, New York Times. The suit, if Allergan were to win, threatens to overturn a regulatory structure that has existed for quite a while. Allergan claims that it is protecting its First Amendment rights of free speech and its ability to inform physicians about all the information that is available on a product. What are the communications implications of this case?
If Allergan were to win, pharmaceutical companies would be able to promote their products off-label. From the Russo Partners perspective, such a right would be both an opportunity and a responsibility for our clients. The opportunity to discuss the broader literature beyond FDA-approved indications with physicians is clear. However, the risk to a company’s credibility by promoting a product beyond what can be concluded from the literature is high. We would recommend to clients to develop transparent promotion guidelines that are communicated to all interested parties. In this way, the risk of over-promotion is mitigated and the client’s credibility remains intact.