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.
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