FDA Grapples With Social Media | Audet & Partners, LLP

FDA Grapples With Social Media

As businesses continue to capitalize on social media as an inexpensive and effective advertising tool, pharmaceutical companies are struggling to find ways to embrace this trend while abiding by FDA regulations, “…fear of offending the FDA has led pharmaceutical makers to be overly cautious and shy away from social media—even if they’re not violating the law.”[i]

Social media has existed as a platform for patients with health concerns since the 1990s. “Some people are surprised to learn that online discussion forums and listservs dedicated to specific patient populations had their genesis in the 1990s…when we consider that people with issues (especially rare ones) are driven to find the information they need, it makes perfect sense.”[ii]    This drive for information is the perfect source for pharmaceutical companies to gain “a better understanding of patient needs” and a “familiarity with the social channels they use and the ways they interact.”ii  However, the risks associated with pharmaceutical companies engaging in social media have inhibited their ability to capitalize on these opportunities.

These risks are directly connected to FDA regulations regarding reporting of adverse drug experiences.  The FDA defines an adverse event as follows[iii]:

Any adverse event associated with the use of a drug in humans…including the following:  An adverse event occurring in the course of the use of a drug product in the professional practice; an adverse event occurring from drug overdose whether accident or intentional; an adverse event occurring from drug abuse; an adverse even occurring from drug withdrawal; and any failure of expected pharmacological action.

Should a pharmaceutical company become aware of an adverse event, they are required to report it as an “Alert Report” within 15 days of initial discovery.  This provision is the main source of grief for pharmaceutical companies and their ability to actively engage in social media due to the fact that social media is a platform for discussion and feedback.  “Companies are concerned that commenters will post about adverse side-effects, off label use of drugs and inappropriate comments.” [iv]  The content of the comments left by patients is of particular concern because of the FDA requirement that adverse drug experiences be reported.

The FDA has yet to provide concrete guidelines to pharmaceutical companies regarding the requirements for reporting of such comments.  In 2001, a draft called “Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines,” was issued that advised pharmaceutical companies to report these types of comments if they meet four criteria[v]: 1. An identifiable patient; 2. An identifiable reporter; 3. A suspect drug or biological product; 4. An adverse experience or fatal outcome suspected to be due to the suspect drug or biological product.

One of many challenges of this type of proposed advisory guideline to pharmaceutical companies is the sheer mass amount of social media content and a company’s ability to collect that content and review it to determine if it falls within these guidelines.

A simple solution to this problem would be for pharmaceutical companies to restrict the ability of readers to post comments or require pre-approval prior to posts being published, which was their initial plan of action until a change in Facebook policy restricted this option.   When this occurred, many companies such as Johnson & Johnson and Astrazeneca removed their Facebook pages.  “The regulatory environment and changes in Facebook functionality are creating a much more difficult environment for managing these kinds of pages, “ said Bill Price, a Johnson & Johnson spokesman[vi].

Despite an email from Shelly Brugess, an FDA spokesperson, in 2011 stating that, “Policy and guidance development for promotion of FDA-regulated medical products using the Internet and social media tools are among our highest priorities,”vi nothing has been issued and pharmaceutical companies remain “in the dark as to how expansive their obligation is with respect to adverse drug experience reporting via social media…”vi

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