BETHESDA, MD 16 June 2010—FDA on Tuesday launched a new website for health care professionals and consumers that summarizes safety information about recently approved drugs and biological products.
The Postmarketing Drug Safety Evaluations website, which FDA officials plan to update quarterly, initially displayed information about 26 products that were approved in 2007 and 2008.
Only one product on the list, GlaxoSmithKline`s rotavirus vaccine, Rotarix, required a labeling change related to information gained during the postmarketing review. Investigations are ongoing for two other products on the list, but no labeling changes have resulted yet, according to FDA.
"For the most part, we`re not being surprised by anything we`re seeing," said Robert Boucher, of FDA`s Office of Surveillance and Epidemiology, during a media briefing Tuesday.
Boucher said the summaries are an addition to other FDA investigations and communications about medication safety and do not replace those activities.
He said the summaries are the result of "a comprehensive process that looks at all of the . . . premarketing data, all of the postmarketing reports, the literature, the postmarketing studies, and characterizes kind of the universe of safety with an emphasis on things that are new and were previously unknown."
The website and summaries were created to help FDA comply with the Food and Drug Administration Amendments Act of 2007. The act requires FDA to prepare a safety summary for drugs within 18 months after their approval or after their use by 10,000 people, whichever is later. According to the act, the summary must contain an analysis of adverse event reports and identify "any new risks not previously identified, potential new risks, or known risks reported in an unusual manner."
"We can`t emphasize enough the importance of postmarketing safety reports," Boucher said.
He said that the labeling for newly approved drugs contains safety information from controlled clinical studies but lacks critical information about the use of the drugs in "the real world."
Boucher said clinical studies are usually of short duration and limited scope and enroll small populations that do not reflect the diversity of users once a product is introduced to the market. For those reasons, he said, adverse events, especially rare but serious ones, may not show up during clinical use but could occur after a product is approved and used by many thousands of patients.
Boucher said 20 or 30 products in addition to those listed on the initial summary remain under review by FDA staff and will be incorporated into future updates.
