Vaccine Safety Website

FDA launches website with safety data on new drugs, vaccines.
USA Today (6/16, Rubin) reports, "The Food and Drug Administration launched a website Tuesday where patients and healthcare professionals can find safety information about recently approved drugs and vaccines." On its Postmarketing Drug Safety Evaluations site, the FDA plans to include "what it has learned about the safety of a new drug or biologic, such as a vaccine, 18 months after approval, or after 10,000 patients have used it, whichever comes later." Robert Boucher, an official in the FDA's Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research, said the agency will make a "broad sweep" of adverse-event reports, medical studies and drug utilization databases.
The AP (6/16, Perrone) notes that the "agency plans to publish the summaries on a quarterly basis," and each "new drug, including drugs approved back to September 2007, will receive a safety summary within roughly two years of approval, according to the FDA."
Bloomberg News (6/16, Peterson) points out that the first reports will include "medications for infections, hypertension and depression, the FDA said."