Without detailed FDA guidance for marketing online, pharma has struggled to comply with FDA guidelines issued before the Internet existed. The primary challenge was ensuring that commentary complies with established regulatory requirements, including: 1) presenting fair balance of benefits and risks, 2) reporting known adverse events to the FDA, and 3) not endorsing usage for a condition not on FDA-approved labeling.
Fortunately, there are several easy ways to comply with regulatory requirements and ensure prompt posting of approved submissions. These include expedited regulatory review processes, external third party pre-screens to reduce internal review volume, and asking very specific questions rather than inviting unrestricted commentary.The Social Media Significance
Patients and physicians are both heavy users of social media, giving pharma the opportunity to build stronger consumer and professional relationships. By better understanding experiences, successes, frustrations, and needs, industry can respond with better education and enhanced solutions, increasing compliance and grassroots treatment advocacy.
The opportunity to engage physicians is enormous. Manhattan Research reported in 2009 that 60 percent of doctors use, or are interested in, Web 2.0 social applications. The same study found that physicians who reported using social media prescribed 24 more medications each week compared to physicians not using it.
Pharma can also benefit from a deeper dialogue with patients, who increasingly use social media to manage their healthcare. In 2008, the Pew Research Center reported that 80 percent of online consumers search for health-related information, encompassing official and unofficial sources. Furthermore, an iCrossing 2008 report said that 34 percent of health searchers use social media resources, and 75 percent seek other consumers to exchange information with.
Few Problem Postings
Available data indicates that problematic commentary on social media will be far less than feared. The vast majority of social media behavior consists of observing rather than participating, so pharma's current monitoring and response resources should be able to handle the volume.
Nielsen BuzzMetrics studied 500 messages across disease topics on Google and Yahoo's health sites, and found only one adverse event reported—a caregiver whose mother asked the community whether fluid retention, not listed as a side effect, might mean her chemotherapy medication was working. Similarly, J&J's http://childrenwithdiabetes.com/, a community site for parents of kids with diabetes, allows people to post whatever they want, and J&J's site-monitoring reported fewer adverse events than expected.