For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and FDA’s prescription drug advertising regulations, along with FDA’s interpretations of the law as put forth in guidance documents and warnings to industry. Among other requirements, the regulations establish standards for “fair balance” in which both the benefits and the risks of a drug product must be disclosed in a comparable fashion, as well as criteria for when an advertisement will be or may be deemed false or misleading in violation of the Act. What may be less well known, however, is that oral statements made by representatives of the company – regardless of whether the intended audience for those statements is future investors in the company or the public more generally – can subject those representatives and the company to risks of FDA enforcement action just as written promotional materials or advertisements can if they are deemed to be false, misleading, unsubstantiated, or promoting an unapproved use for the product.
Two fairly recent FDA actions have brought this issue to the fore, the first taking place in November 2013 and the second in March 2015. In both cases, FDA became aware of televised product-specific discussions by a company’s Chief Executive Officer, and the Agency found each of those discussions objectionable for different reasons. The facts of these two situations are important because they underscore the need for companies to be diligent about all product messages and communications that come from employees, even if the venue is not one that is typically expected to fall under FDA scrutiny. One does not need to be making a presentation at a medical conference, running a consumer-directed television commercial, or disseminating sales aids through pharmaceutical detailers to be subject to FDA’s prescription drug advertising regulations, and company policies and procedures (as well as employee training on those policies and procedures) should reflect that reality
The first instance involved interviews by the CEO of Aegerion Pharmaceuticals, Inc. on the CNBC program “Fast Money,” in which he discussed the company’s prescription drug product Juxtapid (lomitapide) capsules – a product that is associated with serious risks that caused it to be approved with a restricted distribution program and a Boxed Warning on the package insert. According to FDA, the CEO’s statements expanded the indications for the product by suggesting it could be used for off-label uses (contrary to specific limitations of use included in the approved product labeling). In addition, FDA alleged that he failed to provide any risk information about the product. The Warning Letter concluded that Juxtapid was misbranded and thus distributed in violation of the Act, and it required the company to disseminate corrective messages to address the “misimpressions” about the approved use of Juxtapid that the CEO’s statements may have caused.
The second, more recent FDA action stemming from oral statements by a company CEO involved an interview that aired on a Lifetime Channel morning show called “The Balancing Act,” a video of which the company also posted on its website. In the interview, the CEO of Protein Sciences Corporation discussed the company’s influenza vaccine, Flublok, and made claims suggesting that the vaccine was more effective than others due to a higher antigen content. FDA found the statements to be unsubstantiated and therefore misleading; the Agency also noted in its Untitled Letter to Protein Sciences that it had previously advised the company and its CEO “regarding the misleading implication of this claim.
The critical take-home message from these FDA warnings is that biopharmaceutical companies should ensure that all media statements and talking points, regardless of the media/venue used or the intended audience, be treated as promotional materials when they discuss a specific prescription drug, biological product, or vaccine. Accordingly, media-directed communications – interviews, press releases, media comments, etc. – should be reviewed and approved by the company’s Pharmaceuticals Advertising Review Committee (PARC), along with typical promotional materials, to ensure that all messages attributable to the company comply with applicable FDA requirements.
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