Introduction

A Harris Interactive Poll says that 88% of online Americans look for health information online while 45.2% of respondents saying that the internet is their primary source of health information. In light of the significant amounts of incorrect information available online, pharmaceutical companies have a duty to help educate their consumers by not only providing them with the right information, but have a duty to make this information easy to access, and via a medium that consumers expect to find this information.

Pharmaceutical companies realize this necessity and have taken steps beyond using television or radio advertisements or even posting a static web-page. Many pharmaceutical companies have expressed an interest in taking steps to engage their potential patients. However, in the absence of specific FDA guidances that discuss how pharmaceutical companies should deal with social media, and in light of the significant warnings, fines and penalties that the FDA and other governmental agencies have imposed, many companies are hesitant to explore social media as an option to engage their customers.

What is Social Media?

While individuals in the pharmaceutical companies often agree that social media is the “newest, latest and greatest” form of communicating with their patients, few have defined what that term “social media” means. The term “Social Media” typically brings to mind, the abstract requirement of requiring the use of the internet to communicate. Some would argue that there must be some element of “mobility” associated with the media. Others argue that there must be some significant portion of interactivity. Others yet argue that social media must have some element of being device neutral and not being tied to the apple operating system, chrome operating system or windows operating system. Others point to specific platforms, like Linkedin, Twitter and Facebook, and assert that these platforms are “social media” never quite alienating what is considered not to be “social media.”

For the purpose of this blog, we will be defining social media merely as tools and platforms that use the internet as a channel for communication. Such tools not only include Linkedin, Twitter and Facebook, but also include patient communities, blogs, discussion boards, chat room discussions and websites.

FDA’s View on Social Media

The FDA has often indicated that it treats social media the same as every other type of media. Early indications of this “medium neutrality” is seen in the enforcement actions against several pharmaceutical innovators. Specifically, this has been seen in enforcement actions relating to YouTube and Facebook. The FDA’s enforcement actions against individual companies, though not necessarily indicative of its official position against companies in general, provides us with informal indications of how it intends to respond to similar situations.

Problem

The “take away” is typically: If the consumer or intended audience can see, hear or have a message hinted at, and the company control’s the message, it is “fair game” for the FDA to assert that it reflects the company’s official position on the promotional message. While “seeing” and “hearing” are difficult enough to control, the “hinted at” portion of promotional pieces is particularly worrisome since what constitutes a “hint” is not objectively well defined.

Traditional FDA Enforcement

While the FDA, HHS and the DOJ have long had the authority to go after illegal activities by pharmaceutical companies, and have often used this authority, the last two years have demonstrated the FDA’s renewed focus and zeal associated with the enforcement against such activities. While such enforcement activities were often limited to audit reports, untitled letters and warning letters culminating in corporate integrity agreements, the stakes are much higher this time around. Some of the notable enforcement activities have included combining forces with the FTC and engaging in enforcement proceedings against “responsible corporate officials” in combination with the Department of Health and Human Services (HHS) and the Department of Justice (DOJ).

Is the FDA out of Date?

In 2013, according to the Pew Internet & American Life Project, 80 percent of Internet users, or about 93 million Americans, searched for a health-related information. Additionally, 41% said that they use social media as a source of health care information. A significant portion of this information necessarily includes the drugs and devices that they may be using or considering using. The FDA recognizes these changes in information gathering and also recognizes limitations imposed by the new media. It has nevertheless continued to maintain that information provided by pharmaceutical companies is subject to the same rules irrespective of how the information is distributed. While this consistency is useful for many, the interactive nature of the Internet causes significant problems particularly as it relates to what to do with information that is received as a result of such interactivity and limitations in disclosures.

FDA Tries Catching Up

The FDA addressed several concerns with multiple guidances it released that address the following issues: (1) responding to unsolicited requests (2) fulfilling regulatory requirements when using tools associated with space limitations (3) fulfilling post-marketing submission requirements and (4) correcting misinformation.

Due to the continually changing nature of the Internet, the FDA has indicated a reluctance to address its guidances specifically to how a promotion on a specific platform, such as twitter or facebook, should look. Instead the FDA addressed themes such as how should the risks and benefits be balanced out when there are significant space limitations. The aforementioned guidances from the FDA are therefore “platform independent.”  The following sections detail what we know, and theorizes on what the FDA is likely to propose and enforce in the coming weeks and months.

Crystal Ball (Not Legal Advice)

As previously mentioned, the rules haven’t changed. The FDA has indicated a continued desire to regulate, as it always has, the content and not the medium/platform of distribution. The internet is, in many ways, like a combination of a television, radio, and print promotional piece, with the interactivity of a ham radio. The FDA has outlined in its guidances, how it treats, television, radio and print promotional pieces. It has also outlined the interactivity elements, to the extent it was relevant at the time, in its relation to the activities of sales people and medical liaisons. In light of the FDA’s expressed opinions that it is unlikely to change its requirements, based on the mode of distribution of information or steer wide of those previous recommendations.

Tasigna

There have been several commentators who have reviewed the FDA warning letters and asserted that the Tasigna FDA warning letter has allegedly changed the rules since it looks at meta-data. It may, however, be too soon to tell if the rules have genuinely changed.

Meta Data

Meta-data, in general, is composed of information that is not visible to the general public unless certain unusual acts are taken by the audience (such as reviewing the code itself). There is, however, another class of meta-data, that is usually kept away from the public until such time as the intended audience acts in a way, desired by the promotion designer, that would force the reveal of this confidential information. The meta-data in question, in the Tasigna Warning Letter, was of the second type.

In the Tasigna Warning letter, the meta-data in question, when revealed by the audience, resulted in writing that the FDA deemed to be “misleading” because “it [made] representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug.” This seems entirely consistent with the FDA’s position that misleading information would be considered to be worthy of its attention and enforcement power. There is no indication that this was in any significant way different from several other OPDP enforcements over the years. The takeaway continues to be: the FDA expects a fair balance of risk and benefit information.

Adverse Event Reporting

The FDA has typically required that to report individual adverse events, typically referred to as an individual case safety report or “ICSR”, the following minimum information must be available: (1) Identifiable Patient (2) Identifiable reporter (3) Suspect Drug (4) Description of the event. (Postmarketing Adverse Event Reporting for Non Prescription Drug Products Marketed Without An Approved Application, 2009) If these criteria are met, the adverse event is generally reportable. Considering the anonymous nature of the internet, these criteria may often not be satisfied since the reporters and/or patients may use anonymous identities that would preclude a pharmaceutical company being able to contact the appropriate reporter/patient for further information. Nevertheless, it is expected that if all the information is provided, the ICSR must be appropriately filed.

As important as knowing what is likely to be regulated, is knowing what the FDA is unlikely to want to regulate.

Limits of likely FDA Enforcement

The FDA’s core mission includes being “responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” In furtherance of this mission, the FDA regulates, via OPDP, APLB and CDRH, information that is distributed to consumers and healthcare providers. However, information such as software code, including specific meta -data that is typically unavailable and doesn’t affect typical consumer/ healthcare providers will be unlikely to be targeted by the FDA to be worthy of its attention and enforcement. Resultantly, while we may see additional examples of the FDA looking at meta-data and evaluating whether specific meta-data may be misleading, it is unlikely that the meta-data in question have constituted a “game changer” in that they were available and viewable to the general public.

Future Marketing Compliance Strategy

A marketing strategy that includes the internet, will require an assessment of the internal capabilities of the company. A typical marketing and promotions meeting has traditionally included clinicians, lawyers, regulatory folks and marketing folks from both the brand strategic divisions and from the print and broadcast media sections. Unfortunately, few of these experts can fully appreciate concerns that fall outside their areas of expertise. This can result in gaps in communication. These gaps in communication can result in significant amounts of blame shifting and can cause people to “hear” each other’s concerns, but render them unable to truly comprehend why specific concerns are valid. It is hence important that multidisciplinary individuals who can communicate across multiple subject matters be at the table to “translate” for other team members. Call us now to have the Kulkarni Law Firm assist companies with such expertise.