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Executive Summary

FDA has the authority to winnow out indications it deems are "approvable" from those that are not over sponsors' objections, Center for Drug Evaluation and Research office directors stated in a Jan. 15 memo to CDER staffers on the policy for "Implementation of NDA Approval Based on Agency Modifications of Sponsor's Labeling." FDA's general counsel has concluded that the agency "may defensibly use administrative procedures to separate an application with both approvable indications and indications [FDA is] not prepared to approve," the memo states. Thereafter, the agency may decide to "either not approve the other [indication] or convert it to an effectiveness supplement to the newly approved NDA." "In spite of the need for sensitivity to appearances and the concerns of sponsors, [FDA] should use this authority where appropriate to avoid needlessly delaying approval of a drug that the Center has determined is approvable for at least one indication," the memo states. FDA added that "this will have the beneficial effect to the public of avoiding gratuitous patent term restoration and will help approval times more accurately reflect the agency's capacity to act in a timely fashion." FDA is careful to distinguish in what situations this procedure may be implemented. "The most appealing case for use of the procedure is where we are prepared to take final action on all parts of the application(s), i.e. approve one or more indications and refuse to approve the other(s)." The more complicated cases are those "in which [FDA is] not prepared to render a judgement on the indication(s) [it is] not prepared to approve." The agency must determine whether its inability to render a decision is due to division slowness in reviewing certain parts of the application or "the sponsor's failure to file a complete and reviewable application," the memo states. If the additional indications are sought in a major amendment to the original drug application or were in the original NDA but are the subject of major additional submissions, especially new studies, "the delay is clearly the sponsor's responsibility" and the claims would be converted to efficacy supplements, the memo notes. However, if the data supporting multiple indications are submitted together and review of one indication has proceeded faster than other parts of the NDA, FDA said that it will "complete the review of all indications and reach final conclusions on all claims." For minor changes in labeling initiated by the agency, FDA said it will draft a version of the labeling and send it to sponsors, providing them with an opportunity to respond. Discussions over minor changes in labeling frequently concern the warnings and precautions sections and class labeling. Sponsors sometimes reject class labeling for their products in an effort to distinguish their particular drug for competitive reasons. The agency says it will take a tough stance in the future on the class labeling issue. The impetus for the policy statement seems to have been the recent protracted discussions with Warner-Lambert over the approval of its oral quinolone Penetrex (enoxacin), although there is a history at the agency of having to negotiate approval times for anti-infectives. Penetrex was "approvable" for a year, with the delay resulting from Warner-Lambert's disagreement with FDA over the agency's refusal to approve all indications sought by the company. The memo alludes to the Penetrex situation, noting that FDA consulted with its general counsel in December "about the possibility of approving one indication for a drug when [the agency was] not prepared to approve others, in a case where the sponsor had not accepted this decision and had not submitted labeling containing only the acceptable indication." The Dec. 31 Penetrex approval was for gonorrhea and urinary tract infections, not for the broader lower and upper respiratory tract infections and skin infections indications ("The Pink Sheet" Jan. 6, p. 10). The company has yet to launch the product and is considering outlicensing or copromoting the drug.

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