Drug & Device News

The U.S. Food and Drug Administration (FDA) has created a new Web-based information source to inform medical providers and patients about safety issues that arise soon after newly approved drugs and biologics have entered the market. According to an FDA release, the Web site will be helpful because “[s]ome side effects may not become apparent until after a medicine has been approved and becomes available to a larger, more diverse population than the patients who participated in clinical trials that supported approval.”

The new side-effect summaries will be based on reports made by manufacturers, health care providers, consumers and others to the FDA's Adverse Event Reporting System (AERS) and the Vaccine Adverse Event Reporting System, as well as from information obtained from medical literature and ongoing drug studies. Information in this system may not always be up to date, however, because the law requiring the FDA to communicate with the public about ongoing safety monitoring (Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)) requires only that the agency prepare the safety summaries within 18 months after a product's approval, or after it has been used by 10,000 patients, whichever comes later.