Pharmaceutical Failure to Warn…. On Facebook?

The Facebook page of Switzerland-based drug maker, IBSA Institut Biochimique S.A. (“IBSA”), appeared innocent enough:

If you have just been diagnosed with hypothyroidism or are having difficulty controlling your levothyroxine blood levels, talk to your doctor about prescription Tirosint, a unique liquid gel cap form of levothyroxine.

In an untitled letter to the drug maker on February 28, 2014, FDA advised IBSA that its Facebook webpage was false or misleading because it made representations about the efficacy of Tirosint, but failed to communicate any risk information associated with its use and omitted material facts regarding Tirosint’s FDA-approved indications.

FDA advised IBSA that the webpage misbranded Tirosint within the meaning of the Federal Food, Drug and Cosmetic Act (“FDCA”) and made its distribution violative of federal regulation. Specifically, FDA referenced 21 U.S.C. 352(a), (n); 321(n); 331(a); and 21 CFR 202.1(e)(5). Further, FDA reminded the company that Tirosint is associated with a number of serious risks and includes a Boxed Warning indicating that Tirosint should not be used for the treatment of obesity or for weight loss, among other potential risks associated with the use of this medication.  FDA also alleged that IBSA had failed to disclose important limitations on the approved indications of the product, increasing the risk that the product would be used in patients with conditions that were expressly excluded from the approved indications for use.

FDA and the regulated community has been grappling for some time over what might constitute the improvident use of social media. Unquestionably, a pharmaceutical company will run afoul of FDA if product risks are not disclosed. In this instance, FDA noted that IBSA had failed to disclose any (emphasis FDA’s) of the risks associated with the product’s use.

FDA directed IBSA to immediately cease activity violative of the Act and to submit a plan for discontinuing the use of all non-compliant promotional materials.

Despite the public attention given to IBSA’s ill-advised social media posting, the pharmaceutical industry and the medical community have made significant strides in recent years to ensure that physicians are receiving full and complete information concerning the medications they are prescribing for their patients.

One enormous step in the right direction is Sermo, an online community for physicians founded in 2006. Sermo was originally founded by doctors, for doctors. Originally imagined as an adverse effect reporting system without industry influence, Sermo is now a vibrant place where physicians can post observations and questions about clinical issues and hear other doctors’ opinions.

In just a few short years, Sermo has grown to include 200,000 licensed physicians. Some of the heaviest users of Sermo are older physicians, which is somewhat surprising in that the youngest members of a professional group typically adopt technologies first.

Increasingly, the major pharmaceutical companies take the view that social media and other on-line resources can provide an important tool in ensuring that its products are used safely, effectively and appropriately.

At a public hearing conducted by FDA in 2009, Dr. Freda Lewis-Hall, the Chief Medical Officer for Pfizer, reported that the average physician spends about eight hours a week using the internet for professional purposes; that 87% of physicians are interacting with drug and device companies online; and that 60% of physicians are interested in participating in online communities, and that’s when taking security measures like using a VPN such as xtrapc online could be really helpful for protection of the personal data in these online communities. She opined that the majority of physicians want to engage with health care companies in the social media space to obtain drug information.  These physician participation statistics are probably even more striking today.

Pfizer and other companies now communicate with physicians through social media, particularly through collaboration with Sermo. Dr. Lewis-Hall describes Sermo as the online physician’s lounge where informal but highly valuable consults take place.

On January 13, 2014, FDA issued a portion of its long-awaited social media guidance titled “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics“.  Although industry is likely to seek clarification and revision on certain of the rules-of-the-road discussed in the draft, some of the basic concepts expressed are:

1. a company will not be deemed responsible for visitor posts on company-run social media (blogs, chat rooms, message boards, etc) so long as the visitor has no affiliation with the company and the company has no influence over the user-generated content;

2. a company is responsible for content generated by an agent or employee.

3. every advertisement on social media must contain a “fair balance” of the risks and benefits of a drug product and complete disclosure of the product’s approved indications for use.  Query. Could a Twitter entry with its 140-character limit ever meet this standard?  FDA is supposed to provide further guidance on this concern down the line.

4. marketing material postmarketing submission requirements must be complied with for any site where the company “exerts influence…….even if the influence is limited in scope. For example, if the firm collaborates on or has editorial, preview, or review privilege over the content provided, then it is responsible for that content.”  However, if the company only provides financial support to the site, and its influence is otherwise limited, there is not a reporting requirement.

The issue of “exerting influence” is problematic and, despite some helpful hypotheticals in the guidance, ambiguous.  Big Pharma has an interest, perhaps even a responsibility, to be involved in e-media forums where the scientific and medical community is seeking interactive information on pharmaceutical products.  However, the draft guidance arguably produces a push-pull reaction.  Do we engage or, by engaging, do we run the risk of having an added regulatory burden by having to file FDA reports concerning participation on the site?  Some clarity for the industry is warranted to avoid over and under-reporting.

As reflected in this discussion, as all of us – consumers and companies – continue to move forward in a world increasingly dominated by social media, challenges and opportunities abound. On the one hand, there are the missteps, as we see in the case of IBSA. On the other hand, the pharmaceutical industry is moving ahead of the curve to use social media to ensure that its prescribing physicians are well-educated and their patients provided the best possible care. We hope that the final social media guidance facilitates, rather than impedes, this process.

The author acknowledges the important contributions made to this article by Amy K. Dow, a partner at Epstein Becker Green, and Natasha F. Thoren, an associate