Taking into consideration the input from within and outside FDA, ... we have identified the following issues that are important to address: responding to unsolicited requests; fulfilling regulatory requirements when using tools associated with space limitations; fulfilling post-marketing submission requirements; on-line communications for which manufacturers, packers, or distributors are accountable; use of links on the Internet; and correcting misinformation. We are developing multiple draft guidances to address these topics to benefit industry and the public by ensuring that these draft guidances are meaningful and well thought out when they are issued.
While Big Pharma and other interested observers continue to hold their breath (or not), here is my take on this topic, drawn from a paper I wrote last year. Sources are listed in Part 2 of this post.
**
Direct communication between the pharmaceutical industry and patients is increasingly common. An important milestone in direct-to-consumer advertising (DTCA) was the 1995 FDA hearings, at which pharmaceutical companies requested that the FDA clarify the conditions under which broadcast advertisements need not include a brief summary of benefits and risks from the approved product label. The FDA subsequently stated that these advertisements could instead send consumers to a website, toll-free telephone number, print advertisements, or health professionals for this information. Overall pharmaceutical spending on DTCA then shifted from predominantly print to broadcast advertisements and rose from $1.3 billion in 1998 to $4.9 billion in 2007.
While the pharmaceutical industry has consistently argued that DTCA empowers patients by providing information on potentially undiagnosed health conditions and enabling them to initiate conversations with their physicians about treatments, physicians and physician groups have expressed concerns that DTCA would lead patients to request, and doctors to fulfill, inappropriate prescriptions. Limited evidence on the effect of DTCA on prescribing practices, including a single randomized controlled trial of DTCA for antidepressants suggests that DTCA increases prescribing of advertised medications in general, both for appropriate and inappropriate indications.
A survey conducted by the National Consumers League in 2002 indicated that most consumers did not agree that ads for prescription drugs should be restricted to medical journals. These results may reflect changing societal attitudes about the extent to which patients ought to be involved in making their own health care decisions, and the degree to which health information needs to be filtered through physicians.
Social media websites such as blogs, Facebook, and Twitter differ from static web pages in allowing multiple participants to exchange information, ideas, and opinions in real time. The proliferation of social media tools over the past decade has created new opportunities for unmoderated dialogue between health professionals, pharmaceutical companies, and the public, as well as the rapid dissemination (“going viral”) of health-related content to a broad and diverse audience.
Despite the FDA’s stated intention to issue guidance on permissible uses of social media, the pharmaceutical industry has already established or is involved in many online communities relevant to their products. Some examples of pharmaceutical-sponsored social media websites are a Pfizer-authored blog “forum about science and medicine,” Think Science Now; a GlaxoSmithKline-supported “community” for users of its over-the-counter weight-loss drug Alli; and a Boehringer Ingelheim Facebook page that “is not intended as a forum to discuss technical queries regarding specific pharmaceutical products.” Every major drug manufacturer has an active Twitter account, and most have created one or more mobile phone applications.
Although the FDA’s experience with regulating DTCA can help inform its guidance to the pharmaceutical industry regarding social media, the scope of social media communication is considerably larger than advertising alone. Social media channels are varied, evolving, and for the most part, not under direct industry control. Other unresolved issues include how and where to draw the line between company-sponsored media and “independent” websites, as well as the difficulty in determining financial or other conflicts of interest held by health bloggers, many of whom are anonymous.
As a result of the above concerns, social media activities of the pharmaceutical industry generally have not included DTCA. Only 4% of the $4 billion that the industry spent on DTCA in 2008 on the Internet. Further discouraging online advertising, the industry’s previously-held assumption that fair balance requirements could be satisfied with a “one-click” rule (including a direct link to a web page that contained full risk and benefit information), was overturned when the FDA sent warning letters in April 2009 to 14 companies that had posted brief online ads without risk information on search engines.
