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 Now FDA has released four draft guidance documents to clarify how and what information may be released via the web or internet communications that's in the best interest of patients.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.
- 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. http://blogs.fda.gov/fdavoice/index.php/2014/06/fda-issues-draft-guidances-for-industry-on-social-media-and-internet-communications-about-medical-products-designed-with-patients-in-mind/