The U.S. Food and Drug Administration and PatientsLikeMe are formalizing their longstanding relationship in an effort to explore the potential of patient-generated data to inform regulatory review activities related to risk assessment and risk management.

Under the deal, the FDA will get access to PatientsLikeMe’s 110,000 adverse event reports on 1,000 different medications, which will be used as a supplement to traditional sources. Also, given that some patients take several different drugs, counter-actions will be considered, as well.

“We want to have the collective experience of patients influence in healthcare system and obviously regulatory bodies like the FDA affect what kind of services get marketed,” said PatientsLikeMe Cofounder Ben Heywood to MedCity News. “We have been applying pharmacovigilance to drug safety events… We can bring the patient experience into areas like risk management and programs that the FDA sometimes requires of new drugs.”

Right now, the Agency’s post-approval drug safety surveillance is a spontaneous reporting system of individual case safety reports. Reporting adverse events to the FDA is mandatory for drug manufacturers but voluntary for healthcare professionals and patients. Healthcare professionals and patient groups file the reports with pharmaceutical companies, which are obligated to file these reports with the FDA.

PatientsLikeMe network counts some 350,000 patients and 2,300 conditions.