Friday, June 20, 2014

FDA Issues Draft Guidance for Industry's Use of Social Media to Reach Patients

Patients rely heavily on social media, blogs, and websites owned by companies, advocacy or non-profit organizations, bloggers, and medical/research professionals to obtain educational, medical and drug (or medical device) related information. Of these, the information provided by pharmaceutical companies, via social media or their websites, are among the primary sources; thus, a higher bar for accuracy is expected from them. 

While litigation averse companies put out sketchy information often limited to a copy of drug prescribing information, others combine it with subtle marketing messages (for example, in the form of patient stories) which may influence patients' choices, though very few include recent trials data or clinical experience on their website. Now FDA has released four draft guidance documents to clarify how and what information may be released via the web or internet communications that's in the best interest of patients. These documents are available here and here.

These recommendations for industry include:
  • how to communicate risk and benefits of prescription drugs and medical devices in the setting of twitter and google/yahoo paid searches which require short messages
  • how to present information correcting facts about their drug or medical device that may be misleading or wrong on a third-party website
  • guidance regarding promotional media during post-marketing
  • how to address queries regarding off-label use of approved prescription drugs and medical devices
These FDA recommendations provide best practices for the industry and should benefit the patients. These guidance documents are a result of FDA public hearing in November 2009 where patients groups, industry representatives, healthcare professionals, advertising agencies and other stakeholders were invited to provide comments.

Short of accessing and deciphering published peer-reviewed literature, a properly managed website(s) by industry is a good source of information for patients, doctors and caregivers.

These guidance documents were developed and released by the FDA’s Office of Prescription Drug Promotion in the Agency’s Center for Drug Evaluation and Research (CDER).

Abrams T. FDA Issues Draft Guidances for Industry on Social Media and Internet Communications About Medical Products: Designed with Patients in Mind. FDA Voice. June 17, 2014.

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