On Tuesday, FDA announced that it will release risk summaries about medicines approved after September 2007 and post them quarterly to a publicly accessible website, Reuters reports.
The agency said it already has posted summaries for 26 drugs and vaccines that treat allergies, HIV and high blood pressure, among other conditions.
Background
As part of its efforts to comply with the 2007 FDA Amendments Act, the agency plans to disseminate information about a drug or biologic 18 months after the product’s approval or after 10,000 patients have used it, whichever comes later. The information will be based on post-approval health reports from companies, consumers and physicians (Richwine, Reuters, 6/15).
An FDA official said the agency also will conduct a broad review of adverse-event reports, medical studies, and research and utilization databases to identify possible safety issues (Rubin, USA Today, 6/15).
Website Details
FDA will use the public website to post summaries of its findings and describe actions the agency is taking to address the safety concerns (Rhea, Modern Healthcare, 6/15).
Officials said the website aims to help physicians and patients track drug safety risks and make informed decisions about various treatment options (Peterson, Bloomberg/BusinessWeek, 6/15).
