By Mark P. Goodman, Maura K. Monaghan, Jacob W. Stahl and Cari A. Wint
The authors are with Debevoise & Plimpton. Mark P. Goodman is a litigation partner with the firm in New York. Maura K. Monaghan is a litigation partner with the firm in New York. Jacob W. Stahl is an associate in the firm's New York office. Cari A. Wint is an associate in the firm's New York office.
The pharmaceutical industry, like many other industries, has turned increasingly to the Internet as an important medium by which to communicate with a broad range of potential customers, including healthcare providers, patients, insurers and other third party payors, and trade organizations. Last year, for example, a pharmaceutical manufacturer posted a video on its website showing a patient who had difficulty walking and balancing but who was able to walk and maintain his balance a few months after receiving treatment with the company's drug. The website contained a statement in bold print that the drug did not cure the cause of the patient's symptoms and was not approved to treat other symptoms of the disease. It also stated: “These are videos of actual patients being evaluated by their physician. Individual results may vary. [Drug] may not be effective in reducing [shaky] movements in all  patients.” The website also provided dosing, titration, and risk information. Despite the website's detailed risk disclosures, the Food and Drug Administration's Office of Prescription Drug Promotion nevertheless sent the manufacturer an Untitled Letter, alleging that the video and webpage violated the Food, Drug and Cosmetic Act because the warnings and information were not included within the video itself.
This is but one example reflecting a growing trend of increasing FDA enforcement actions against pharmaceutical manufacturers for online communications and advertisements. Since 2011, roughly 25% of Untitled Letters and Warning Letters issued by the FDA to pharmaceutical manufacturers have concerned online communications. These enforcement actions have not been limited to communications that are blatantly false or misleading. Instead, they have encompassed a range of communications and advertisements that the FDA has faulted for being potentially incomplete or otherwise inaccurate on the ground that the Internet -- by linking information contained on different websites or serving as a repository of comments directly from consumers that are not automatically disclosed to others -- can cause too much or too little information to be directly and immediately available to consumers. Are Twitter and sponsored links, which may provide insufficient space to provide basic risk disclosure information and may require a click to a second site for more detailed adverse event data, too limited to permit adequate disclosure? The FDA's recent actions with respect to Internet advertising suggest they may be, and raise the question of whether the very nature of the Internet renders the FDA's traditional standards inappropriate.
The issues raised by the FDA's enforcement actions to date are likely just the tip of the iceberg. Fortunately for drug manufacturers, the FDA is required by statute to issue guidance regarding Internet and social media advertising by June 2014. Yet despite obvious confusion in the industry, the FDA has given no indication that it intends to accelerate such guidance. In the meantime, manufacturers are left with no choice but to operate in what amounts to a guess-and-check regime. Prudent in-house counsel and compliance officers should therefore ensure that all Internet communications are fully in accord with the FDA's traditional regulations governing labeling, advertising, and adverse event reporting.
The Internet and social media afford pharmaceutical manufacturers a myriad of opportunities to communicate with the public in ways that often do not neatly fit within the regulatory framework the FDA developed to govern traditional media advertisements, which are defined as “advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems.”1 Although FDA regulations contemplate one-way messages from advertiser to consumer, Internet and social media open up a new frontier of interactions between advertisers and actual or potential customers.
For example, many drugs are now promoted through webpages (typically at a domain name titled “www.drugname.com”) that range in complexity from a simple page providing basic information to a collection of numerous pages containing everything from patient testimonials, to suggested questions for patients to ask their doctors, to forms soliciting patient feedback. Pharmaceutical products are also promoted on Facebook, through YouTube videos, or on third party websites such as WebMD.
Companies often direct patients to these Internet sites through another form of digital advertising known as “sponsored links.” These links are short advertisements that appear on webpages viewed by Internet users whose Internet use patterns suggest they may have an interest in a particular drug. Clicking on the sponsored link brings the user directly to the drug's webpage.
Social media have created other opportunities for communications with consumers that transcend traditional webpages. Manufacturers may have a “Twitter” feed where they “tweet” information -- limited to 140 characters -- about the drug they are promoting. Entrepreneurial sales representatives or aggressive companies can also communicate directly with patients or healthcare providers through “chatrooms” that are dedicated to a specific drug or disease.
Despite the absence of regulatory guidance, the FDA in recent years has increased its monitoring of and enforcement directed at online communications. Between January 1, 2011, and June 15, 2013, the FDA issued roughly 140 Warning Letters and Untitled Letters of Violation. Of those, 35 violations (25%) related to online activities, of which 26 (19%) related directly to online advertisements or product claims. Many of these violations relate to advertisements or claims that would be problematic even in traditional media advertisements, such as brochures posted to a website that make unsubstantiated superiority claims or a video that omits important safety risks. However, a number of these violations resulted from the inherent opportunities and challenges posed by the nature of Internet communications, such as the sufficiency of providing risk information on a linked page or failure to report comments left by patients on an interactive website that constitute adverse events.
A number of the Untitled and Warning Letters cite violations are unique to the particular characteristics of the Internet, including activities related to website graphic design, location of safety and other material information, and the use of tabbed or linked webpages.
Website Design Is Misleading.In one instance in 2012, the FDA found that the use of color or graphics on a website or electronic communication was misleading. In that case, the FDA issued an Untitled Letter,2 because it found that the use of bright colors on an image of a brain falsely implied that images created using the product, an injectable imaging agent used to assist with brain scans, could be interpreted or displayed in color. The FDA has also flagged companies for using color or graphics inappropriately in traditional media as well. However, because the use of black and white graphics in online media is rare, companies may be more inclined to use color displays on websites and other online media communications. They should however, ensure that they do so in a way that is not misleading.
Website Does Not Prominently Display Material Information or Risks Along With Benefits.The FDA issued a number of Untitled Letters to companies that presented safety and risk information or other material information inconspicuously, such as at the bottom of a webpage or in small font -- thereby running afoul of the requirement that risk information have comparable prominence and readability to information concerning efficacy.3 The FDA has historically taken action against companies who have buried safety or other important information inconspicuously on print advertisements. However, the placement of information on a website can be particularly tricky because of the user-controlled aspects of the Internet. For example, users control which portions of a website they view by scrolling to the information they prefer to read and users control various display features, including font size, color, and size of their screens.
Website Contains Incomplete Risk or Prescribing Information.The FDA also took issue with websites that presented incomplete risk or prescribing information. For example, the FDA issued an Untitled Letter in 2012 to the manufacturer of an antidepressant that included on its webpage the language “MAO-inhibitors are contraindicated with certain drugs” (emphasis in original), but failed to list the specific drugs that should not be used in combination with the drug. In addition, the website omitted certain risk information contained in the package insert, saying instead “Please see Full Prescribing Information, including BOXED WARNING…” (emphasis in original) at the top and bottom of the website page. The FDA found that the website omitted serious risks and that the overall effect of the presentation minimized the risks associated with the product and therefore misleadingly exaggerated the safety of the drug.4 Although the FDA's guidance for television advertisements permits manufacturers to include a brief statement about major risks and instructions as to where detailed risk information can located, the FDA's digital enforcement actions suggest that similar abbreviated statements on websites may be insufficient.
Material or Risk Information Contained on Linked or Tabbed Pages.As a result of space or character constraints, companies often will include certain information about a product on a linked or tabbed webpage. However, the FDA has frequently taken action against manufacturers that placed information about a product's benefits on a main website page, but posted information about risks on a linked page. For example, the FDA issued a Warning Letter to a manufacturer finding that it misbranded its product because the product website contained “number of claims regarding the benefits of the drug but failed to include any risk information on the same page.”5 In that instance, the website contained a link labeled “Important Safety Information” that led to a page that presented the product's risk information. The FDA has issued a number of Untitled Letters to manufacturers relating to the use of linked websites. In one case, the FDA issued an Untitled Letter to a manufacturer whose website dedicated to a specific product contained links to individual websites for three other products. Each link contained the product's name and stated “Learn about treatment for [the indication of the product],” then, when clicked, took the user to that product's website, which contained complete package insert (“PI”) information. The FDA objected, claiming that the first webpage impermissibly made “suggestions of efficacy of [the drugs],” named in the links “but fail[ed] to communicate any risk information.”6
In December 2012, the FDA issued a Warning Letter to a drug company for claims made by alleged users on the company's Facebook page where users “Liked” the drug and then uploaded testimonials about it. For example, one user wrote “[Drug X] has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously…” The FDA asserted that the manufacturer's silence on the post implied that the manufacturer endorsed its content.
Also in 2012, the United Kingdom's Medications and Healthcare Regulatory Agency (MHRA) found that a company had failed to report a large number of adverse event reports that were collected during clinical trials and from the company's internal reporting system as part of its Patient Assistance Program. A number of the unreported events were submitted by patients on interactive product-related websites. The company had not monitored the sites for adverse event reports and therefore allegedly failed to identify and report tens of thousands of possible adverse events. At the time of publication, the FDA was looking into the matter but had not publicly taken any formal action against that company.
Companies should observe the same standards for promotional materials and communications posted online that they observe for comparable communications disseminated offline. If the FDA would object to the content in a video, brochure, or sales aid when distributed through traditional channels, the FDA is almost certain to find problematic the same content when disseminated online. Indeed, even a web posting or blog entry by a sales representative is likely to be treated as a violative company communication.
Similarly, companies should observe the same standards for targeting patient populations online as they do offline to avoid inadvertent off-label promotion. The FDA may well view communications targeted at patient populations with symptoms or interests that are inconsistent with a product's approved indication as evidence of misbranding. As such, Internet users should be targeted with great care to avoid potential liability for off-label promotion.
Feedback from patients, ranging from the exuberant to the disgruntled, may create regulatory risks. Companies would be prudent to limit or prevent patients from making public posts on a company-sponsored webpage or Facebook page because a satisfied patient could easily make claims that are not consistent with the drug's label. Such postings may lead to FDA allegations of overstated claims, unapproved indications, or even off-label marketing. By contrast, postings or communications by a disgruntled patient -- whether made publicly on a webpage or privately in response to a questionnaire or comment field -- may be treated as an adverse event. A company that permits any type of feedback on its website should have appropriately trained personnel monitoring the site to identify and disclose to the FDA any adverse events.
The space constraints imposed by sponsored links, short video clips, and other websites should not be viewed as an excuse for non-compliance with fair balance and risk disclosure requirements originally designed for traditional media. Although the FDA's Thomas Abrams was quoted earlier this year as stating that he believes pharmaceutical companies can make compliant statements about their drugs in as little as 140 characters, his statement should not be construed to suggest that such statements are exempt from FDA enforcement. Indeed, to the extent that a company makes positive statements about a drug on a sponsored link, there likely will not be enough space to provide an acceptable risk disclosure. And, as many companies have already learned, the FDA will not likely agree that a communication is fair and balanced simply because the full risk disclosure or package insert is just a click away on the company's website. If space is limited, a product reminder ad, which does not require full risk disclosure, may be the safest option.
Copyright 2013, The Bureau of National Affairs, Inc.
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