Health IT, Pharma

PatientsLikeMe-FDA research collaboration seeks to increase patient experience of drugs in post market reviews

PatientsLikeMe and the FDA will explore the potential of patient-generated data to inform regulatory review activities related to risk assessment and risk management.

In an effort to make more information available about side effects of drugs from the people taking them to improve drug safety, the U.S. Food and Drug Administration and PatientsLikeMe have formalized a longstanding relationship, according to an announcement at the Drug Information Association conference this week.

Under the collaboration, PatientsLikeMe and the FDA will explore the potential of patient-generated data to inform regulatory review activities related to risk assessment and risk management, according to a company statement.

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

The collaboration agreement means the FDA will have access to 110,000 adverse event reports on 1,000 different medications as a supplement to traditional sources, including the adverse event reporting system.

In a phone interview, PatientsLikeMe Cofounder Ben Heywood told MedCity News: “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. 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.”

He added that given that some patient take several different drugs, interactions are a consideration too.

PatientsLikeMe network includes 350,000 patients and 2,300 conditions.

Photo: Flickr User Lee Royal

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