FDA changes approval letters for pharmaceuticals

WASHINGTON The Food and Drug Administration is changing the way it responds to pharmaceutical manufacturers’ applications for marketing approval of new drugs when the application cannot be approved as submitted.

The Center for Drug Evaluation and Research will no longer issue “approvable” or “not approvable” letters when an application is not approved instead, the CDER will issue a “complete response” letter to let the company know of the agency’s decision. The new letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to get the application ready for approval.

“Complete response” letters are already used to respond to companies that submit biologic license applications. Now, the process for drugs and biologics will be consistent under the new regulations.

Currently, when assessing new drug applications, the FDA can respond to a sponsor in one of three types of letters: an “approval” letter, meaning the drug has met agency standards for safety and efficacy and the drug can be marketed for sale; an “approvable” letter, which generally indicates that the drug can probably be approved at a later date provided that the applicant provides certain additional information or makes specified changes (such as to labeling); or a “not approvable” letter, meaning the application has deficiencies generally requiring the submission of substantial additional data before the application can be approved.

According to Janet Woodcock, director of the CDER, “Thorough and timely review of drug applications is a priority of the FDA, and these new processes will make our communications with sponsors of applications more consistent.”

These changes, which will become effective on Aug. 11, 2008, are not expected to directly affect consumers.