FDA Will Tell All When New Drugs Get Thumbs Down

By Peggy Peck
ROCKVILLE, Md., 10 july 2008 -- Beginning next month, the FDA will tell drug companies whose drugs fail to win approval exactly how and why their investigational agents fell short.
In the past, the FDA has issued an "approvable" letter when a drug was not cleared for immediate marketing pending requested additional data but not essentially rejected outright, as in "non-approvable" letters. These "approvable" and "non-approvable" letters were notable for their vague and often puzzling content, which often left drug makers, physicians, and patients confused.
Replacing that system, the FDA will issue a complete response letter when it has completed its review of a new drug application.
The letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to get the application ready for approval.
Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said the new policy "will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form."
The FDA will continue to issue approval letters for drugs that pass muster.
Complete response letters are already used to respond to companies that submit biologic license applications. The process for drugs and biologics will be consistent under the new regulations.
The revision should not affect the overall time it takes the FDA to review new or generic drug applications or biologic license applications. These changes will become effective on Aug. 11.