FDA to Clarify Regulation of Online Drug, Device Ads

April 20, 2010 | Professional Liability | Intellectual Property

As part of its presentation to the U.S. Food and Drug Administration about America’s increased dependence on the Internet for health information (and the role that Google can play in that regard), Google estimated that more than 100 million Americans conduct 4.6 billion health-related keyword searches annually.[1] Similarly, a study by the Pew Internet and American Life Project reported that 61% of U.S. adults are e-patients (individuals who look online for health information), including not just Web-based researchers, but those who turn to social networking sites, such as Facebook or MySpace (39%) and Twitter (12%). Moreover, 60% of e-patients report that their online research has impacted their health decisions.[2]

Certainly, then, the Internet presents prescription drug and medical device manufacturers and distributors with significant opportunities to provide information about new and existing products to potential customers, and to market directly to consumers.

The rules governing advertising on the Internet are constantly evolving to accommodate concerns of honesty, reliability, and accountability. Those rules get more complicated when the products are prescription pharmaceuticals or medical devices marketed by manufacturers governed by a detailed federal regulatory scheme.

Generally speaking, under federal law, promotional materials about prescription pharmaceutical products and medical devices are required to be truthful and non-misleading, and toward that end they must contain risk information.[3] These rules typically are well understood by pharmaceutical and device companies in most advertising contexts. However, they were written before the explosion of online advertising, and it can be difficult to apply these rules to the Internet. Indeed, almost exactly one year ago, on April 2, 2009, the FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) sent letters to 14 pharmaceutical companies stating that the companies’ sponsored links on search engines (e.g., Google) for a variety of products were “misleading”[4] because, among other things, they made representations or suggestions about the efficacy of the products but failed to communicate “any risk information associated with the use of these drugs.”[5]

Moreover, in DDMAC’s view, it was insufficient for the sponsored links to contain a link to the products’ Web sites. Such a link, the DDMAC declared, did “not mitigate the misleading omission of risk information from these promotional materials.”

The problem these companies faced resulted from the limitations inherent in the online advertising programs in which they participated. For example, the Google AdWords program limits the space available for ads. Under the program’s rules, ads “can contain, including spaces, 25 characters for the title, 70 characters for the ad text, and 35 characters for a display URL.”[6] Similar issues exist as to advertising on other search engines, and can arise with the 140 character limit imposed by Twitter or other limitations inherent to some social media.

The situation is further complicated when one considers the implications of Internet advertising on product liability claims against drug and device companies. For example, there is a general concern that sponsored ads, in their brevity, overwhelm the “fine print” that is also generally available, usually at the company Web site. The concern is, in part, based upon the fact that sponsored ads are passive content, as a consumer need do nothing more than browse the Internet to have them delivered based on an automated assessment of what might be of interest to that consumer. Conversely, risks, limitations of use, and warnings generally need to be affirmatively sought by the individual, whether by affirmative searching or even just clicking on a company Web site link.

Similarly, online ads may implicate a company’s ability to rely on a “learned intermediary defense” to a failure to warn claim, whose success depends on the manufacturer having supplied adequate warnings of risks to the user’s learned intermediary – the prescribing physician.[7] To counter such a defense, it can be anticipated that a plaintiff may offer the content of sponsored ads or social media that a manufacturer deliberately targeted to the consumers.

More than four years ago, the FDA recognized that a number of questions had arisen regarding the application of the advertising and labeling provisions, regulations and policies to promotion on the Internet. It explained that the following questions had to be explored:

  1. How should product information be presented to ensure that Internet users will know that the product information is available and where it is available?
  2. Does it matter where product information is located on a Web site? If so, where should it be located?
  3. How can product information be clearly distinguished from other information on the Internet (e.g., disclosure statements)?
  4. How should product information be presented on the Internet to ensure that the user has access to a balanced presentation of both side effects and contraindications and information relating to effectiveness? For example, should ‘fair balance’ be considered in the presentation of information on every screen? In every advertisement or promotional piece? Or on the entire Web site?[8]

Today, the FDA does not have regulations specifically addressing online advertising by drug and device companies, but it appears that that is going to change, as the FDA is expected to issue regulations covering Internet advertising by pharmaceutical companies later this year.[9]

Last November, the FDA held a public hearing to provide an opportunity for input and comment on the promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools.[10] The hearing resulted in over 1,000 pages of transcripts with suggestions for FDA regulations,[11] as well as numerous industry, consumer advocate, and other comments submitted by the FDA’s February 28 deadline.[12]

For example, in comments it submitted on February 26,[13] Merck & Co., Inc., encouraged the FDA to issue regulations that would permit pharmaceutical companies to provide “accurate and balanced information” about the benefits and risks of their products in digital media that have space or formatting limitations, such as search engine sponsored advertisements. It also suggested that the FDA consider allowing hyperlinks to lengthy disclosures, as is allowed for the required disclosure of indication and risk information for medical product-claim.[14] Merck also had suggestions for regulations with respect to a pharmaceutical company’s Web-based media, including message boards on a company controlled site, as well as Web-based media not under a pharmaceutical company’s control.

The industry group PhRMA also submitted comments to the FDA, and proposed that the FDA should permit manufacturers to contain a standard warning in sponsored online search results, such as, “All drugs have risks. Click here for important safety information from the manufacturer,” which then would link to a site with complete details on the drug’s risks.

Following the close of the comment period, in the middle of March, the FDA indicated that the absence of regulations governing Internet advertising by the pharmaceutical and device industry is about to change because the FDA is going to propose regulations governing online advertising by manufacturers of FDA regulated drugs and devices. At present, it is too early to know exactly what the regulatory scheme will cover. We do not yet know whether regulation will provide a useful construct for manufacturers to safely and efficiently provide meaningful information to potential consumers or simply establish a standard that will provide a retroactive measurement for manufacturer liabilities.

It would appear, however, that the FDA has sufficient information, from its public hearing and otherwise, to propose comprehensive rules that will give clear guidance to advertisers, search engines and social media, and consumers on the required form and content of such advertising.

Conclusion

Not long ago, in September 2009, the FDA reported that it would use Twitter to announce information about drug safety and regulation. As the FDA observed at that time, “Messages on Twitter provide consumers, health care professionals, the pharmaceutical industry, and others with timely information on new drug approvals, safety alerts, compliance actions, and consumer information.”[15]
It is ironic that despite its own recognition of the utility of social media, the FDA has not yet promulgated standards for manufacturers and distributors of FDA regulated drugs and devices to follow in their use of social media, Web sites, search engines and other Internet tools.

That the FDA has undertaken that task by first obtaining the input of manufacturers, industry representatives, and consumer advocates is cause for optimism that the regulation will facilitate consumer access to accurate, honest, and complete product information.
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  1. Google, “A Proposal for Sponsored Links: Connecting Consumers to Important Health Information,” November 2009, available at: http://www.scribd.com/doc/22485073/Google-FDA-Public-Hearing.
  2. Fox, Susannah, Jones, Sydney, The Social Life of Health Information, Pew Internet & American Life Project, June 2009, at http://www.pewinternet.org/Reports/2009/8-The-Social-Life-of-Health-Information/01-Summary-of-Findings.aspx?r=1.
  3. See, 21 CFR 200.200, 201.100(f), 202.1(e)(2)(i)), 801.1, 801.4-6, et al.
  4. See, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM143536.pdf.
  5. See, e.g., DDMAC letter to Eli Lilly, available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM143536.pdf (emphasis in original).
  6. See, http://adwords.google.com/support/aw/bin/answer.py?hl=en&answer=6095.
  7. See, e.g., Marcus v. Specific Pharmaceuticals, Inc., 77 N.Y.S. 2d 508 (Sup. Ct. N.Y. Co. 1948). See, also, Sterling Drug, Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966)(“We are dealing with a prescription drug rather than a normal consumer item. In such a case the purchaser’s doctor is a learned intermediary between the purchaser and the manufacturer. If the doctor is properly warned of the possibility of a side effect in some patients, and is advised of the symptoms normally accompanying the side effect, there is an excellent chance that injury to the patient can be avoided.”)
  8. See, Promotion of FDA-Regulated Medical Products on the Internet; Notice of Public Meeting, 61 Fed. Reg. 48,707 (Sept. 16, 1996).
  9. See, http://techdailydose.nationaljournal.com/2010/03/fda-to-regulate-online-drug-ad.php.
  10. http://www.fda.gov/aboutfda/centersoffices/cder/ucm184250.htm.
  11. See, http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM193462.pdf and http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM193463.pdf.
  12. See, http://www.regulations.gov/search/Regs/home.html#searchResults?Ne=11+8+8053+8098+8074+8066+8084+1&Ntt=FDA-2009-N-0441&Ntk=All&Ntx=mode+matchall&N=0.
  13. See, http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480aaf89e.
  14. See, http://www.ftc.gov/bcp/edu/pubs/business/ecommerce/bus41.pdf.
  15. See, http://www.fda.gov/Drugs/ucm181556.htm.

Reprinted with permission from the April 30, 2010 issue of the New York Law Journal. Copyright ALM Properties, Inc. All rights reserved. Further duplication without permission is prohibited.

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