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Executive Summary

FDA POLICY ON SINGLING OUT NDA INDICATIONS FOR APPROVAL is intended to expedite drug reviews and, given its limited scope, does not represent a "liability" to industry, FDA Commissioner Kessler maintains in a recent letter to the Pharmaceutical Manufacturers Association. "Given the relatively small number of times the policy has been used and the limitations within the policy itself," Kessler states, "I do not believe the policy represents a liability to the industry." He noted that "indefinite stalemates over proposed labeling or the non-approval of entire applications would not appear to better serve either [PMA's] membership or the public. Kessler's Sept. 16 letter to PMA responds to the association's comments on a Jan. 15 internal Center for Drug Evaluation and Research memo, which outlined FDA's position on selecting out for approval only some of the indications included in an NDA even though the sponsor objects. The January memo states that FDA's general counsel 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 Pink Sheet" April 6,p. 13). In a July 31 letter, PMA asked Kessler to "withdraw" the proposed policy, arguing that it would discourage sponsors from pursuing narrower uses of a drug early on in development out of fear that FDA will approve those uses and "relegate" major uses to efficacy supplements ("The Pink Sheet" Aug. 10, In Brief). "I believe that both the memorandum and the spirit in which CDER developed it may have been misunderstood" by PMA, Kessler states in the letter. He noted that the policy was developed by CDER late last year "as one of several actions to expedite the drug review process." He explained that a number of reviewing division directors had run into situations where NDA sponsors "declined to accept CDER's decisions as to which indications were approvable, initiated protracted discussions (sometimes for over a year), and then publicly criticized the agency for delay." Kessler said that the memorandum "was CDER's attempt to avoid returning such applications as non-approvable when some of the indications were approvable." Kessler also noted that the general counsel's office "concluded that notice and comment rulemaking was not required to implement the policy." He added: "The agency's position that this policy and its implementation are legally authorized remains unchanged." Nevertheless, FDA currently is preparing a policy statement based on the January memo (called "Implementation of NDA Approval Based on Agency Modification of Sponsor's Labeling") for publication in an upcoming Federal Register. The policy is unlikely to appear before the end of the year. In rejecting PMA's legal argument that an NDA approval should be a "yes-no" decision, Kessler argued that "an NDA is not an unvarying, unchanging document. New indications, studies, data, and analyses are often added [and,] similarly, indications have often been removed." Also, he continued, "unlike a contract negotiation, an NDA approval does not require a 'meeting of the minds.'" Kessler maintained that "the very fact that an NDA can include amendments and supplements contradicts the notion that the NDA is in effect a singular request." Kessler also emphasized that the policy "was not intended to deliberately influence the availability and length of patent term restoration." The CDER memo states that the policy "will have the beneficial effect...of avoiding gratuitous patent term restoration." Kessler said in the letter to PMA that the memo "was merely recognizing that in certain cases, a sponsor's unwillingness to proceed occasionally may be reinforced by the knowledge that extending the review clock could have effects regarding patent term restoration beneficial to the sponsor."

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