Social Media Promotion in an FDA Regulated World -- Part (iv)

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.

Social Media Promotion in an FDA Regulated World -- Part III

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 following minimum 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.

Social Media Promotion in a FDA regulated World -- Part 2

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 to youtube 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."