PAPER NDA APPROVALS, WITHOUT LITERATURE REFERENCES, ARE BEING WEIGHED BY AGENCY, FDAer MORRISON SAYS: COULD STIMULATE PRODUCT IMPROVEMENTS, ME-TOO EXCLUSIVITY

FDA is considering a regulation to permit a generic company to file a 505(b)(2) [paper NDA] application that establishes the safety and efficacy of the active ingredient simply by referring to the agency's decision to approve the pioneer product, FDA's James Morrison told a Dec. 9 session of the Food & Drug Law Institute annual meeting. The FDA reg would revive the paper NDA approval, but would not require literature references. Discussing issues that might be addressed in FDA's post-1962 ANDA regulations, Morrison said: "Instead of a reference to studies in the literature, we believe that an applicant might be permitted to refer to an agency finding of safety and effectiveness of the pioneer drug as a means of satisfying the requirement for the underlying data." Morrison is the deputy director of the Drug Standards Office. The revised paper NDA procedure would facilitate agency processing of an application for a me-too product with an innovative improvement over a pioneer version. Applicants for such products "would simply be required to provide data on whatever innovative change is made on the basic product," Morrison said. An improved product could qualify for three years of exclusivity. "It would seem fair to give ANDA holders the same rewards for innovation that NDA holders enjoy," he maintained. However, a generic marketer who seeks an innovative change currently must file a full NDA -- with "scientifically unnecessary and duplicative" safety and efficacy studies of the active ingredient -- or a 505(b)(2) application -- when there are published reports of adequate studies of the active ingredient. ANDA supplements do not by law accommodate innovative changes that are awarded exclusivity, he said. "Under the provisions of the statute you cannot get exclusivity" for an ANDA, Morrison noted. Furthermore, "the Generic Drugs Division had no capability for review of clinical studies, so clinical supplements would have to be referred to the new drug divisions." The agency is also considering whether marketing exclusivity can be treated as a "property right," which can be licensed like patent rights, Morrison disclosed. "One fundamental issue we're considering" is whether exclusivity is "more like a property right held by the innovator, such as a patent, or whether it is simply a prohibition against the agency's approving a generic product during the period of time." Exclusivity would be "more valuable" as a property right, "and hence more of an incentive for innovation," because it "could be bought and sold," Morrison contended. However, "the statute is written in terms of a prohibition against [subsequent] agency approval," he said. "Strictly read, the exclusivity provisions protect only the innovator itself, not other interested parties that bought into the process." The act specifies that the studies on which the innovative product's approval is based "must have been conducted by or for" the company seeking exclusivity, he said. Generic Drugs Div. Consumer Safety Officer Robert Pollack provided a rundown of agency experience with ANDA suitability petitions. In 1984, it was estimated that FDA would receive one or two suitability petitions per month; however, Pollack noted, the agency has received 230 petitions for an average of approximately 10 per month. FDA has taken final action on 173 (76%) of the petitions, he said: 95 were approved, 40 denied, and 38 withdrawn. Roxane and Abbott "have been the most prolific petition filers," Pollack continued. Having submitted 24 and 22 petitions, respectively, they account "for over 21% of ANDA suitability petitions. Although 81 different firms have submitted petitions, 56% submitted only one petition each," Pollack said.