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Executive Summary

Generic drugs may be classified by FDA as therapeutically equivalent to pioneer drugs for nonexclusive indications, even when the brandname product has exclusive marketing rights to other indications, Rep. Waxman (D-Calif.) maintained in a Nov. 5 letter to the agency. "The [act's] exclusivity rules prohibit FDA only from approving generics for those indications covered by exclusivity. The effect is to make illegal any promotion or labeling of a generic for the exclusive use," the congressman asserted. Brandname company arguments "that the exclusivity rules address FDA's authority to declare generic drugs to be therapeutically equivalent [have] no foundation in the act," said Waxman, the House author of the legislation. Waxman's comments were in response to citizen petitions filed earlier this year by the Washington law firm Royer Shacknai & Mehle and by the Pharmaceutical Manufacturers Association. The petitions asked that FDA not declare generics therapeutically equivalent in the Orange Book when their labeling differs from listed drugs' labeling, due to exclusive indications ("The Pink Sheet" Jan. 20, p. 6; May 12, T&G-6; and May 26, T&G-5). "I view these petitions as additional efforts in a long series of now all too frequent antigeneric activities to deny the American people the fruits of the act: lower priced drugs." the congressman said. Waxman maintained that in drafting the ANDA/patent law "Congress understood that the practical effect" of market exclusivity awarded for development of a new indication "is the same as when a generic is approved for a drug which has one indication still under patent. There will not be an exclusive market for the brandname drug," he said. "As such, the incentive for development of an additional indication will not be as strong as when the drug is under patent or under the new chemical entity exclusivity rule." Had the legislature "intended for the exclusivity rule to provide protection against generic approval for nonexclusive indications or against a therapeutic equivalence finding regarding a generic approved for nonexclusive indications, Congress would have prohibited FDA from either approving the generic drug or making a therapeutic equivalence finding" Waxman said, pointing out: "Congress did neither." The Generic Pharmaceutical Industry Association's outside patent counsel Alfred Engelberg submitted two Oct. 29 letters to FDA to oppose the citizen petitions. Engelberg contended that the motive for the petitions "is to obtain an economic advantage. . . by depriving the generic competitors of the therapeutic rating which is essential to approval for generic substitution by state formularies." Engelberg maintained that the ANDA/patent law "does. . . expressly approve of the practice of granting approval to market generic drugs even though they are labeled for less than all of the approved indications for the branded product." He noted that the House Energy & Commerce Committee report on the act explicitly endorses such generic approvals. "An ANDA must include sufficient information to show that the conditions of use for which the applicant is seeking approval are the same as those that have been previously approved for the listed drug"; however, the report states, "the applicant need not seek approval for all of the indications for which the listed drug has been approved."

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