Posted on: 4/18/2012
Michael A. Walsh, Strasburger & Price
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The Internet revolutionized how we obtain information, and social media has revolutionized how we share it. However, the current regulatory landscape created by the Food and Drug Administration (FDA) for medical product manufacturers is comprised of old rules designed for old media, wherein a medical product manufacturer's online speech and active participation in the dissemination of truthful product information creates an enormous risk of civil and criminal prosecution. This lack of clear regulatory guidance constrains manufacturers from providing meaningful and reliable product information.
In defending FDA's regulatory approach, its Commissioner recently stated:
Now I know that in some circles regulation is viewed as a roadblock to innovation and economic growth. But in actuality, when done right, regulation isn't a roadblock; it's the actual pathway to achieving real and lasting innovation… Going forward, smart regulation requires regulatory flexibility that responds to changing situations, new information and new challenges.
Margaret Hamburg, M.D., 50 Years after Thalidomide: Why Regulation Matters, FDA Voice (February 7, 2012), http://blogs.fda.gov/fdavoice/index.php/2012/02/.
Unfortunately, FDA may be failing to respond to "changing situations" and its opportunity to do it "right" is passing. There remains an immediate need for regulations that comport with the new era in information gathering.
For medical product manufacturers, three main 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 healthcare information. Mark Bard, Wired for Health: Consumer and Physician Demand for Digital Health, Pharma and Social Media Resources, ePharma Physician (2009), available at http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM195751.pdf. In the last quarter of 2007 alone, there were "4.6 billion health-related searches across all search engines in the U.S." Mary Anne Belliveau, Amy Cowan, A Proposal for Sponsored Links – Connecting Consumers to Important Health Information, Google (Nov. 2009), available at http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM195758.pdf. 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.
Consumer health-related searches are driven by medical events, with users looking for a "truth-risk value proposition," and consumers find "personal experience" content most useful. See Promotion of FDA Regulated Medical Products – Using the Internet and Social Media Tools: Public Hearings before the Food and Drug Administration, p. 391 (Nov. 12, 2009)(statements of Kathleen Fourte). It is estimated that 78 percent of people "suffering" use the Internet, id. at 352 (statements of John Mangano), and two-thirds of them say online information has improved the physician-patient dialogue. Id. at 418 (statements of Larry Mickelberg). In one survey, 46 percent of respondents said social media helped but they thought the content was unreliable. Id. at 362. According to the research, users search online first, then 86 percent ask their physicians about the information they found online. See id. at 73 (statements of Jeff Francer).
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 healthcare professionals seeking health and medical product information. See e.g. Bard, Wired for Health: Consumer and Physician Demand for Digital Health, Pharma and Social Media Resources.
In November 2009, FDA held additional hearings regarding the use of the Internet and social media by manufacturers of FDA-regulated products. See Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools, Food and Drug Administration, available at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm184250.htm (last updated Dec. 27, 2011). 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." See id. Since that time, 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. See Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices, Food and Drug Administration (Dec. 2011), available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf. 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 (76 Fed. Reg. 243, 78663-78667 (Dec. 19, 2011)) (http://www.gpo.gov/fdsys/pkg/FR-2011-12-19/html/2011-32275.htm); 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) (76 Fed. Reg. 249, 81508-81510 (Dec. 28, 2011)) (http://www.gpo.gov/fdsys/pkg/FR-2011-12-28/html/2011-33188.htm). 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, FDA is standing on the sidelines, confounded by how to fashion new rules to allow its most potent participant, the manufacturer, to participate meaningfully.
The absence of clear rules regarding online communications, particularly any clearly guiding manufacturers as to how they can provide truthful information concerning their products, has left manufacturers uncertain about what they are permitted to do. This regulatory void hinders the most potent source of reliable health information specific to medical products, both for consumers and healthcare professionals. A number of speakers at FDA's 2009 hearings expressed the inherent problems in this lack of direction as follows:
- "[I]t is a travesty in this day and age when we have the technology to provide the most comprehensive and transparent medical information to those who can rely on it daily – the healthcare professional." Promotion of FDA Regulated Medical Products – Using the Internet and Social Media Tools: Public Hearings before the Food and Drug Administration, p. 267 (Nov. 13, 2009)(statement of David Saggio).
- "[T]he vacuum created by the absence of manufacturer activity within the social media ecosystem has been quickly filled by…user-generated [content]." Promotion of FDA Regulated Medical Products – Using the Internet and Social Media Tools: Public Hearings before the Food and Drug Administration, p. 426 (Nov. 12, 2009)(statement of Dr. John Reeves).
- Google testified that after FDA issued 14 Notices of Violation on April 2, 2009, which claimed "misbranding" based on FDA's assessment that sponsored links on company websites failed to communicate risk information, the "click through rate" (i.e., the number of times an ad was delivered divided by the number of times it was clicked on) fell off precipitously. This illustrates that FDA's approach to restricting industry conduct reduced the availability of manufacturer-generated content to searchers. Promotion of FDA Regulated Medical Products – Using the Internet and Social Media Tools: Public Hearings before the Food and Drug Administration, pp. 436-38 (Nov. 12, 2009)(statements of Mary Ann Belliveau and Amy Cowan).
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.
While FDA's concern for "fair balance" in presenting risk and benefit information may intuitively seem to promote the public health, a recent analysis of literature suggested 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.
The study surveyed 20 years of literature on the impact of FDA risk communications on healthcare utilization. Most of the studies reviewed demonstrated a "spillover" effect, where non-target populations were impacted. Most notable among the examples cited was that warnings provided regarding a particular drug related to suicide risks in adolescents resulted in both a decrease in use of the drug by adults and an increase in suicide rates after the decline in prescriptions. The authors concluded that their "review indicates the varied and unpredictable impact that [warnings] can have and suggest the importance of continuing to characterize the effect of advisories and warnings on a variety of behaviors to enhance the science of risk communications regarding prescription drugs." See id.
Consumers expect manufacturers to not only know what is being said about their products online but also to provide useful information. Yet, 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 healthcare information.
Many manufacturers take the "ostrich approach" or the "we weren't required to monitor" approach. While this may avoid regulatory enforcement action, it could prove to be a weak defense in the product liability context. Fundamental to all product liability cases is the question of what the manufacturer knew and when it knew it. The online "social revolution" and consumer assumptions that manufacturers are present and monitoring online communications will raise the question of where did you look and what did you do about it? Moreover, this industry stance, driven by fear of civil and criminal enforcement, may not be well-received by an already skeptical consuming public, and, most importantly, it leaves an information void where useful health-related information could be provided.
At the hearings in 2009, precious few suggestions were made by manufacturers. See Promotion of FDA Regulated Medical Products – Using the Internet and Social Media Tools: Public Hearings before the Food and Drug Administration (Nov. 12 and 13, 2009).
Among the suggestions made by a number of the speakers include the following:
- Hire people to monitor the Internet using Internet monitoring tools
- 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."
- Use "widgets" to convert public conversations to private communications
- Create an FDA logo or "seal of approval" for reliability
- Standardize the presentation of product information
- MedWatch Adverse Event reporting should be easy to use and hard to miss on the Internet
- Establish SOPs for monitoring for Adverse Events on Social Media
- Relax prior FDA approval and oversight requirement at time of dissemination. Current rules hinder the flow of information and are inconsistent with the way users are searching.
- "End the culture of fear" – reverse the "see no evil hear no evil" approach to avoiding Federal enforcement
As FDA ponders its options, the Internet has morphed into a platform for personal interaction regarding healthcare 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. As it stands now, 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 healthcare 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.
Mike Walsh is a partner in the Dallas office of Strasburger & Price and leads the firm's Drug and Device Industry Team. He devotes most of his practice to representing clients in FDA regulated industries on issues related to labeling, and is a member of the DRI Drug and Device Committee and the Laws and Regulations Committee of the Association of Food and Drug Officials.