Social Media Promotion in an FDA Regulated World

Social Media Promotion in an FDA Regulated World 

There have recently been a spate of warning letters, fines, corporate integrity agreements (CIAs), against pharmaceutical companies and individual actions against people working in the pharmaceutical industry. Several of these penalties have related to illegal promotions and alleged off-label discussions. Nevertheless, because the industries patient's continue to seek health information online, these companies must continue to risk significant penalties to ensure that their patients get the most accurate information possible, via a medium that the patient considers desirable. Resultantly, the industry continues to promote its products online, via various methods including social media, despite what the industry, and the FDA, consider to be inadequate guidance.

This blog is hence the first in a series of related blogs relating to social media and promotion via social media, and what is the likely future of social media in an FDA regulated environment.

Introduction

According to a Harris Interactive Poll: 88% of online Americans look for health information online, with 45.2% of respondents of a burst media poll saying that the internet is their primary source of health information. In light of the significant amounts of incorrect information available online, pharmaceutical companies not only have a duty to help educate their patients, by providing them with the right information, but also have a duty to make this information easy to access and in a medium that these patients expect to find this information. 

Pharmaceutical companies realize this necessity and have hence taken steps beyond simply using television or radio advertisements or even posting a static web-page. Many pharmaceutical companies have expressed an interest in engaging their potential patients in a two way discussion. However, in the absence of specific FDA guidance, 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 pharmaceutical companies are hesitant to jump into these perilous, “shark infested waters.”

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 suggest that there must be a significant portion of interactivity for the medium to be considered “social media”. Others yet argue that social media must have some element of being device neutral and not being necessarily 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 not considered to be “social media.” We will be defining Social Media in the abstract: 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.

Current State of the Art

The United States is part of an exclusive group only two countries that allow Direct to Consumer (DTC) advertising of specific prescription drug products. However, this special treatment carries with it several rules and regulations that must be followed. Specifically, in the event of a DTC promotion discussing a specific drug, a drug company must make significant disclosures in accordance with FDA requirements.

In the alternative, not directly talking about a specific drug, for example by discussing a disease state, affords pharmaceutical companies some flexibility relating to the type and extent of disclosures and risk information that must be shared. These non drug specific advertisements are not ideal since they do not promote an individual product. Nevertheless, they carry certain advantages including (1) a reduction in necessary risk discussions, (2) flexibility of the message communicated and (3) limited liability associated with such an advertisement. Additionally, such promotions allow companies to directly connect and interact with the needs of their patients. Resultantly, several drug companies actively supporting patient communities built around specific disease states, in addition to promotions of specific drugs.

In the next posting, we will be discussing the FDA's position on promotion via the internet.

This section focuses on the FDA's opinion of social media and promotion via the internet in general and social media in particular. 

FDA’s Opinions

INTRODUCTION

The FDA has often hinted that it treats social media the same as every other type of media. Early indications of this “medium neutrality” has been seen in enforcement actions against several pharmaceutical innovators. Specifically, in the case of social media, this message has been communicated in enforcement actions relating toyoutube and facebook.

The FDA’s enforcement actions against individual companies and based on specific violative promotions may not necessarily indicate its official position against companies in general. Nevertheless, these enforcement actions provide us with informal indications of how it intends to respond to similar stimuli.

For the most part, a “take away” that has often been seen is: If the consumer/ intended audience can see, hear or have the company message hinted at, the FDA considers to “fair game” to assert that such a message reflects the company’s “official position”. While “seeing” and “hearing” are difficult enough to control, the “hinted at” portion of promotional pieces is particularly worrisome since what constitutes a “hint” has not been objectively well defined.

IMPACT AND FINES

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 Federal Trade Commission (FTC), and engaging in enforcement proceedings against “responsible corporate officials” in combination with the Department of Health and Human Services (HHS) [4] and Department of Justice (DOJ)[5].

What is likely to be Regulated?

41% of surveyed individuals said that they use social media as a source of health care information.[6] A significant portion of this information necessarily includes the drugs and devices that these individual may either already be using or are actively considering using. The FDA recognizes these changes in information gathering methods, and seems to understand that there are limitations imposed by this “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 relating to “medium neutrality” is useful for many, the interactive nature of the Internet causes significant problems particularly resulting from the innate interactivity associated with the internet, and limitations in disclosures that such media necessitate .

The FDA has indicated that it intends to address several of these concerns with multiple guidances it intended to originally release starting in 2010. The release dates of those guidances have, unfortunately, now been pushed into the first quarter of 2011.[7] This write-up intends to address some of the impending guidances and the potential directions it may take.

The next blog posting shall focus on specific themes that the FDA is likely to follow in the regulation of this "new media." 

THIS BLOG ENTRY, IS A CONTINUATION OF TWO (2) PREVIOUS ENTRIES. IT WILL BE DISCUSSING SPECIFIC THEMES, AND THE LIKELY POSITION OF THE FDA RELATING TO THESE SPECIFIC THEMES AS EXPLAINED BELOW. 

THEMES:

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 twitter or facebook should look, and will instead address themes such as “responding to unsolicited requests”. The expected, aforementioned guidances from the FDA are therefore expected to be “platform independent.”  The following section details what we know, and theorizes on what the FDA is likely to propose in the coming weeks and months.

Medium neutrality

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 of distribution. The internet is, in many ways, like a combination of a television, radio, and print promotional piece, with the interactivity of an individual sales person. The FDA has outlined, in its guidances, how it treats, television, radio and print promotional pieces. It has also outlined  interactivity, to the extent it was relevant at the time, to the activities of sales people and medical liaisons. In light of the FDAs expressed opinions that it is unlikely to change its requirements, based on the mode of distribution of information, the FDA is unlikely to steer wide of those previous recommendations.

Whatever your consumer sees.

There have been several commentators who have reviewed the FDA warning letters and asserted that the Tasigna FDA warning letter[2] has allegedly “changed the rules” since it looks at meta data. I believe that it is too soon to tell if the rules have genuinely changed.

Meta data, in general, is usually information that is not visible to the general public unless certain unusual acts are taken (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 “hidden” 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 [failed] 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 DDMAC enforcements over the years. The takeaway continues to be: the FDA expects a fair balance of risk and benefit information.

Reporting adverse events as reported online

As previously indicated, the FDA has typically required that to report individual adverse events, typically referred to as an individual case safety report or “ICSR”, the followingminimum information must be available: (1) and identifiable patient (2) an identifiable reporter (3) a suspect drug and (4) a description of the event.[3] 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.

The next entry will relate to what is not likely to be regulated by the FDA, and conclude with some advice for sponsors on who they may want in their next marketing meeting.

This is the fourth (4th) and final part to the blog series relating to social media in an FDA regulated world. This section deals with what the FDA is unlikely to want to regulate, and how to potentially tackle some of the communication problems associated with social media promotions.

Part IV

What is not likely to be regulated?

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

SOURCE DOCUMENTATION THAT YOUR CONSUMERS WILL NOT SEE:

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 divisions in CDER, CBER and CDRH, information that is distributed to consumers and healthcare providers.

However, information such as software code, including specific meta-tags that are typically unavailable to the typical consumer/ healthcare provider, will be unlikely to be targeted by the FDA, and will likely be deemed to be unworthy of its attention and enforcement.

Resultantly, while we may see additional examples of the FDA looking at meta-tags and evaluating whether specific meta-tags may be misleading, it is unlikely that the meta-tags in evaluated so far have constituted a “game changer” in that they were available and viewable to the general public.

Where does that leave us?

As we discussed, a marketing strategy that includes the internet, as it now necessarily should, will require an assessment of the internal capabilities of the company. A typical marketing and promotions meeting has always included clinicians, lawyers, regulatory folk and marketing folk from both the strategic divisions and from the print and broadcast media sections. It is important to understand and appreciate that other folks may be necessary in these meetings.

MULTI-DISCIPLINARY TEAM MEMBERS

There are multiple parties involved in meetings relating to promotional compliance. These parties, as previously suggested, may include lawyers, clinicians, regulatory and marketing individuals. These individuals or teams each have their own jargon and communicate in ways that are unlikely to be understood by other individuals at such meetings. This jargon, and varied understanding, heightens the risk of miscommunication between the parties. This risk of miscommunication often maximizes the chances of problems occurring, and in the event of an actual problem may result in finger pointing and blame shifting. It is hence important that multidisciplinary individuals who can communicate across multiple subject matters be at the table to “translate” for other team members. Typically, such individuals must necessarily have not only an understanding of the clinical discussion but at least one if not more other factors that must be considered by other members at the meeting. This ability to translate for other members will allow for team building and rapport generation and provide the teams the ability to work through any possible mis-communications, resulting in decreased violative content being allowed to “pass through” such promotional meetings.