FDA, PatientsLikeMe Partner To Test Adverse Event Reporting
June 16, 2015 in News
FDA uses adverse event reports to regulate drugs once they are on the market (Comstock, MobiHealthNews, 6/15).
Adverse event reporting is mandatory for drug manufacturers. However, it is voluntary for health care professionals and patients. When providers or patient groups file adverse event reports with drug companies, drugmakers then are required to share the information with FDA (Baum, MedCity News, 6/15).
Currently, FDA collects adverse event data through:
- MedWatch, a voluntary reporting system; and
- The Sentinel Initiative, which involves partnerships between insurers and electronic health record system providers that allow access to aggregated data sets (MobiHealthNews, 6/15).
Details of Partnership
The partnership between FDA and PatientsLikeMe will examine the potential for patient-generated data to be used in regulatory review activities associated with risk assessment and management.
Through the partnership, FDA will gain access to 110,000 adverse event reports on about 1,000 medications, according to MedCity News. The information will work as a supplement to traditional resources for adverse event data (MedCity News, 6/15).
Gerald Dal Pan — director of the Office of Surveillance and Epidemiology at FDA’s Center for Drug Evaluation and Research — said MedWatch and the Sentinel Initiative provide “coded data.” He said the partnership with PatientsLikeMe aims to “supplement that information with more information about the patient’s voice, having the patients tell us their experience in their own words.”
Further, Dal Pan noted that the partnership will help FDA determine whether PatientsLikeMe data contain sufficient information to determine whether a drug caused a certain adverse event (MobiHealthNews, 6/15).