The Internet revolutionized how we obtain information, and
social media has revolutionized how we share it. Yet the current
regulatory landscape created by the Food and Drug Administration
(FDA) for medical product manufacturers is comprised of rules
designed for old media, wherein a medical product
manufacturer's on-line speech and active participation in the
dissemination of truthful product information creates an enormous
risk of civil and criminal prosecution. The lack of clear
regulatory guidance constrains manufacturers from providing
meaningful and reliable product information.
For medical product manufacturers, three questions arise concerning their use of the Internet and social media: (1) what can they say?; (2) what are they responsible for (i.e., third-party content and adverse event reporting)?; and (3) what are the consequences of not participating?
In 2009, approximately 158 million users looked online for health information, and 50 million people used the Internet as their first source for health care information. (Click here to view the original research findings.) In the last quarter of 2007 alone, there were "4.6 billion health-related searches across all search engines in the U.S." (Click here to view the presentation written by Google's Health division.) As patients are increasingly managing their healthcare online, social media are quickly surpassing television and print media as the primary source of health-related information.
Overwhelmingly, consumer health-related searches are driven by medical events, with users looking for a "truth-risk value proposition," and "personal experience" where two-thirds of them say online information has improved the physician-patient dialogue. Id. at 418 (statements of Larry Mickelberg). Patients are not the only ones managing health information online. According to survey data, 90 percent of physicians are online, and 75 percent are online daily. Physicians no longer simply rely on professional society meetings, journals, sales representatives, and interactions with colleagues in hospital hallways to gain information. Now, this exchange of information is being conducted on a grand scale online.
Consumers and healthcare professionals are not changing how they think because of social media – rather, social media is adapting to work the way people think. Health-related communities are forming and evolving, making interactions more productive, informative, and immediate.
In 1996, FDA held hearings to address the then newly-forming Internet, which was capable of delivering health information without the time limitations of TV or the space limitations of print media. Since 1996, the Internet has become the primary choice of both consumers and health care professionals seeking health and medical product information.
Thirteen years later, in November 2009, FDA held additional hearings regarding the use of the Internet and social media by manufacturers of FDA-regulated products. In connection with those hearings, FDA stated that "[p]olicy and guidance development for promotion of FDA-regulated medical products using the Internet and social media tools are among our highest priorities." Among the date presented to FDA at those hearings included:
- Manufacturers should correct third-party content survey data
reflected that 59 percent of the public agree
- "companies are big enough and have enough money to make sure the Internet is accurate."
- "End the culture of fear" – reverse the "see no evil hear no evil" approach to avoiding Federal enforcement
Since that time, and despite being "among [FDA's]
highest priorities," FDA has done little to update the
regulatory landscape to (1) allow manufacturers to disseminate
truthful health-related information regarding its products or (2)
provide guidance on what, if anything, a manufacturer must do to
monitor third-party information concerning its products.
In December 2011, FDA issued its draft Guidance on Unsolicited Requests, which addressed new media but provided minimal guidance in this regard. Also in December 2011, FDA posted two notices: (1) Examination of On-Line Direct-to-Consumer Drug Promotion, which is an effort designed to conduct a series of studies to determine how best to present risk and benefit information on branded drug websites; and (2) Communications and Activities Related to Off-Label Uses of Marketed Products and Use of Products not Yet Legally Marketed (i.e., Scientific Exchange). While these current initiatives may bear on the use of the Internet and social media by manufacturers of FDA-regulated products, it is uncertain when, or if, FDA will take meaningful action. Because FDA cannot regulate the online communications or content of the consuming public or healthcare professionals, "the vacuum created by the absence of manufacturer activity within the social media ecosystem has been quickly filled by...user-generated [content]." FDA is fidgeting on the sidelines, confounded by how to fashion new rules to allow its most potent participant, the manufacturer, to participate meaningfully.
This regulatory void hinders the most potent source of reliable health information specific to medical products, both for consumers and healthcare professionals.
Industry should be an active participant in any dialogue concerning its products. But fear of FDA's criminal and civil enforcement and penalties has led the industry to take the FDA's threats seriously and manufacturers anxiously sit as bystanders. Rather than permitting industry to step in, (no matter how imperfectly), to inject truthful, reliable, scientific information, the regulations instead restrict participation and punish missteps. (See, for example, the 14 Notices of Violation issued by FDA on April 2, 2009 claiming "misbranding" (a crime under the FDCA) where risk information was a scroll or click away.
While FDA's concern for "fair balance" in presenting risk and benefit information may intuitively seem to promote the public health, a recent study surveyed 20 years of literature on the impact of FDA risk communications on health care utilization that suggests that injecting too much risk data can be as harmful as providing no risk data at all:
"[U]nintended consequences from regulatory warnings...demonstrate the challenge that [FDA] face[s] to design risk messages...that don't become risks themselves." Dusetzina SB, et al. Impact of FDA Drug Risk Communications on Health Care Utilization and Health Behaviors: A Systematic Review, Med Care, Jan. 18, 2012.
While consumers expect manufacturers to not only know what is being said about their products online but also to provide useful information, consumers are unaware that manufacturers are constrained from meaningfully participating in the online dialogue. The absence of reliable product information results in the public trusting "digital strangers" to provide important health care information and further fosters the public's distrust of manufacturers.
As FDA ponders its options, the Internet has morphed into a platform for personal interaction regarding health care issues on a global scale. With no new guidance from FDA in sight, industry is left with rules designed for old world media that restrict and severely punish "incorrect" participation, where both the public and manufacturers must read tea leaves when navigating their way through online health information.
Because the electronic communication frontier cannot be contained, FDA will eventually pave the way and establish rules to allow those who know the most about their health care products to provide truthful, reliable information to those who have a real and immediate need for it. The scope and tools for social media are changing more quickly than FDA can act, and the resulting absence of manufacturer presence in social media may represent a lost opportunity to an entire generation of Americans for advancement in providing important health information.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.