Pharma and Facebook’s face off: why does the industry want to be on Facebook?

Darshan Kulkarni

Kulkarni law firm

Facebook has 750 million active users. 50% of those active users log onto Facebook everyday. The average user has 130 friends. Individuals spend over 700 billion minutes per month on Facebook. The Industry wants to use this highly engaged audience to involve them in the branding and positioning of its products.

Why did the Industry get off Facebook?

Facebook recently came out and effectively said, "We want to encourage conversation. We will hence require that everyone be allowed to comment on facebook pages – This includes you Industry"

"Individuals spend over 700 billion minutes per month on Facebook."

Risks

With Facebook's new policy requiring commenting, and insufficient guidance in the eyes of the Industry, BPMs are left wondering: what are our responsibilities if:

• Someone on my product's facebook page wants answers to off label questions?

• Someone on my product's facebook page reports an adverse event (AE) without sufficient required details? (Does it have to report this AE, or does the anonymity exempt reporting such AEs?)

• We promote our product, but have insufficient space to also adequately disclose its risk / adverse event profile? (Would a single link to the potential risks be enough?)

Impact

These are significant questions for Industry because of the high level of risk associated with interacting on Facebook and on the internet. There have already been cases of administrative, civil and criminal liability, filed by the US government, against individuals working in Industry settings. Additionally, the Industry has already paid multi-billion dollar fines to the government. In light of the significant risks to the Industry in general and individuals in particular, Industry has begun withdrawing its active Facebook pages. Those in the Industry that aren’t already off are making headways into getting off of Facebook.

Did the Industry need to get off Facebook?

Short answer: as the FDA has said, multiple times, as long as previously established rules were followed for Facebook, the Industry was not, per se, required to get off the internet.

"...as long as previously established rules were followed for Facebook, the Industry was not, per se, required to get off the internet."

Depending on the risk tolerance of the company, the Industry could adopt a variety of methods to ensure compliance. The most draconian, of course, being getting off Facebook.

Lesser draconian ways would include (but are not limited to):

• Heavily monitoring a site dedicated to a specific product

Reviewing each posting and change to the site before it gets on the page. This process has 2 major disadvantages: (1) this would likely be VERY costly, and (2) there is a risk that certain messages would get approved when they shouldn’t be due to inadequate vetting. Nevertheless, this process could work if appropriately reviewed and monitored.

• Non product-specific Pages

The Industry could continue to use pages, not dedicated to a specific drug, but instead dedicated to disease states or certain adverse effects (such as some kind of support group). Such sites, as long as they are not product specific, and follow appropriate requirements, may be used to engage potential clients, patients and customers. While the risks of off-label discussions still exist, the risks are relatively minimized since a specific drug is not being discussed. Nevertheless, this risk still exists. The advantage of this methodology is that patients have a way to vent and share their experiences.

• Give up control

If the goal of the Industry is to enhance patient care, and allow for a comprehensive discussion of a specific disease state, consider allowing a hospital or another provider to run its own website to promote awareness of a specific disease state. This is a very tricky option because of the risk of sites putting out messages you dont want, sites discussing products belonging to other owners and the potential for off-label discussions. Additionally, the Industry must not appear to be pulling the strings on the "puppet" that is the healthcare provider.

Conclusion:

The day of telling the patient what to do has come to an end. Patients often expect to participate in their own care. Given the restrictive guidelines and laws, the Industry is having a difficult time addressing these expectations. The Industry must consider allowing patients and providers to channelize their expectations of a responsive company. This could include:

• Alternate method

Provide patients the opportunity to talk to someone about the adverse events they experience. Companies often use a phone number to discuss adverse events. Direct patients and their providers to those phone numbers. Apologize for not being able to engage them on the social media forum (like Facebook or Twitter). Explain succinctly and without using legal jargon, why engaging them on the social media forum, for adverse events, is not feasible.

"The day of telling the patient what to do has come to an end."

• Prompt responsiveness

Offer to have the appropriate person call back the patient/provider.

• Link to explanation

Provide a link explaining why information cannot be provided in the desired forum. Allow them to engage in some kind of communication.

DISCLAIMER: The opinions stated in this blog are the sole and present opinions of Dr. Kulkarni as of the time of writing of the blog in question and do not necessarily represent the legal or medical opinions of Kulkarni, LLC and / or its other attorneys. Such opinion(s) may change over time. These blog postings do not constitute legal advice, and do not create an attorney-client relationship and should not be construed as such. These blog postings also do not constitute medical advice. Please contact your physician for medical advice, and your attorney for legal advice, that is appropriate for you.

About the author:

Dr. Kulkarni holds a Doctor of Pharmacy degree, a Master of Science in Quality Assurance/ Regulatory Affairs, and a Juris Doctorate degree. He works with and/or for research sites, clinical research organizations and a variety of small and large pharmaceutical and biopharmaceutical companies to assist them in meeting their clinical, legal, regulatory and/or compliance needs.

Dr. Kulkarni has worked, and continues to work, as a pharmacist for more than 10 years He currently serves as Adjunct Associate Professor in the Biomedical Writing Program at the University of the Sciences and has taught courses in Regulatory Documentation Processes, Ethical and Legal Issues in Biomedical Communication, Research in Biomedical Communication, and the Promotion of Biomedical Products- Regulatory Considerations.