Dive Brief:
- The FDA is working with PatientsLikeMe, a patient website with 350,000 members that allows users to share information on drug experiences, symptoms and hospitalizations.
- The agency wants to access more information about drug side effects that affect patients' daily lives and may require potential labelling changes.
- The three-year agreement may also influence how fast the FDA can react to a safety issue.
Dive Insight:
The industry is increasingly trying to learn how to leverage patient-generated data to improve outcomes. This agreement gives the FDA an "insider" view of drugs from the patient's perspective—something it previously hasn't had access to. "We're hoping we can find information on the impact of adverse events on patients' day-to-day lives," said Gerald Dal Pan, director of the Office of Surveillance and Epidemiology at the FDA.
PatientsLikeMe has information on more than 110,000 adverse-event reports on 1,000 medications, according to a statement. The website also conducts research with companies—for example, a study with Biogen Inc. gave Fitbit wristband health trackers to multiple sclerosis patients. "There's a lot of interesting app development for reporting adverse events," said Dal Pan. "I think we're going to have to explore the value of social media."