FDA reports new drug safety evaluations
The FDA will now issue quarterly reports of drug-safety evaluations that it has begun on the basis of adverse event reports the agency has received, officials announced here.
The quarterly reports are now being released to alert consumers to drugs that are on the FDA's watchlist and are currently undergoing testing. This move towards quarterly reporting is a direct response to a call for increased transparency when it comes to their drug safety investigations. While there is a concern that patients may react negatively if they discover a drug they are taking is named in the quarterly reports, the FDA has noted that inclusion of a drug in the report does not necessarily mean it is harmful - just that the FDA is responding to submissions from their Adverse Event Reporting System (AERS) and investigating accordingly.
The first list, for January-March 2008, was released 6 months late.
Asked about the six-month delay in compiling the current report, Dr. Seligman said future reports would be issued more quickly. He said the next report, covering April through June, would be out "pretty soon" but declined to be more specific.