The U.S. FTC put brand drug companies on notice Sept. 14 when the commissioners unanimously voted, 3-0, to issue a policy statement recognizing that improperly listed patents in the FDA’s Orange Book “may constitute an unfair method of competition.”
Direct-to-consumer advertising (DTC) for medical devices does not present the same policy footprint as DTC ads for drugs, but Congress recently asked the U.S. Government Accountability Office (GAO) to investigate device advertising to evaluate whether reforms are needed. GAO responded to the effect that while the literature lacks any useful studies on the question, some stakeholders believe that DTC device ads give short shrift to risk information, a finding that may prompt Congress to enact new legislation on the question.
Two U.S. federal government departments recently issued a series of guidelines for their handling of mergers and acquisitions in a draft that has provoked both support and opposition from observers. Barry Nigro of the George Washington University School of Law said he is concerned that the presumption that a transaction is necessarily anticompetitive will prompt litigation over that presumption and thus bog down the process of reviewing these transactions.
