PatientsLikeMe, FDA deal

PatientsLikeMe granted FDA access to the company’s patient-reported data, which the agency said it will use to identify risks and benefits of drugs. The agency said PatientsLikeMe’s adverse event data have the potential to supplement existing sources, including data that sponsors are obligated to report and data from FDA’s Adverse Event Reporting System (FAERS), to address safety issues that arise postmarket.

PatientsLikeMe said FDA will have access to more than 110,000 adverse event reports on 1,000 drugs at no cost. The data include information on drug tolerance, adherence and quality of life. PatientsLikeMe said the collaboration “may lead to FDA-sponsored research projects designed to understand how patient-reported data might be used to enhance post-market surveillance, support regulatory decision making and inform regulatory science.” ...