FDA to Bring Halt to “Approvable Letters”

I’ve never before re-printed a whole press release, but today I am bringing you one from the FDA:

The U.S. Food and Drug Administration today announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.

Under new regulations that govern the drug approval process, FDA’s Center for Drug Evaluation and Research (CDER) will no longer issue "approvable" or "not approvable" letters when a drug application is not approved. Instead, CDER will issue a "complete response" letter at the end of the review period to let a drug company know of the agency’s decision on the application.

"These new regulations 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," said Janet Woodcock, M.D., director of the agency’s Center for Drug Evaluation and Research (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."

Taking the place of "approvable" and "not approvable" letters, a "complete response" letter will be issued to let a company know that the review period for a drug is complete and that the application is not yet ready for approval. The letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to get the application ready for approval.

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 in the United States; 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.

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

In July 2004, the FDA issued a proposed rule on these topics. At that time the agency asked for comments on the proposal. Today’s final rule addresses comments submitted to the agency.

For more information, see:

Link to the Complete Response Final Rule

Link to the drug approval process page

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2 Responses to FDA to Bring Halt to “Approvable Letters”

  1. CMC guy says:

    So is this just a matter of sliding from a position of “Yes once you do XYZ” to “No, until you do XYZ”? Is there more significance here?
    Seems if move to “Thumps up/Thumps down” then could reduce other options. This does not address issue of potential “Conditional Approval” mechanism practiced elsewhere (EU) which may have value in certain circumstances to widen availability of promising treatments.

  2. Kerry Donahue says:

    In other words DENIED!
    Thank you Janet, I hope this will help clarify things for the Sixth Circuit Court. Congressman Dingell are you paying attention?
    See July 2nd comments on eye on fda.
    http://www.eyeonfda.com/eye_on_fda/2008/07/approvable-lett.html
    The FDA continues to play its “we never deny anything game” but looks like they slipped up with their verbiage a little this time. Compare the language to that asserted by FDA counsel in the lawsuit of CareToLive vs. FDA at http://www.caretolive.com