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Executive Summary

Limiting expedited review to only the first ANDAs for "blockbuster" drugs is one suggestion proposed by FDA in a May 30 Federal Register notice requesting comments on "expedited review for economically important drug products." "It has been argued that the first ANDA approvals for a particular drug product account for a substantial portion of the price reduction attributable to the availability of generic drug products and that subsequent approvals do not lower drug prices significantly," the notice says. Therefore, FDA said it might want "to expedite review only for a limited number of ANDAs for a generic version of a 'blockbuster.'" FDA points out in the notice that, because not all ANDAs are approvable, it may be difficult to determine exactly how many to expedite. Another option, FDA suggested, "would be to adopt an expedited review process for all ANDA versions of a 'blockbuster' drug until a sufficient number of ANDAs are approved to achieve a substantial price reduction. Once a sufficient number are approved, a 'first-in, first-reviewed' policy would be reinstated." However, FDA noted, it would then need guidance as to what constitutes a "substantial price reduction." Expedited review for generic versions of blockbuster drugs was first suggested by House Energy and Commerce/Oversight Subcommittee Chairman Dingell (D-Mich.) in an April 6, 1990 letter to then-acting Commissioner Benson ("The Pink Sheet" April 16, 1990, p. 6). The Federal Register notice quotes the letter, which calls an expedited review process "critically important" given the number of "major" drugs coming off patent in the early 1990's. "The FDA should have in place multiple approvals of ANDAs (which meet Waxman-Hatch standards) as the drugs come off patent," Dingell suggested. Dingell also wrote that FDA "should not await the development of . . . guidelines to begin work on the obvious priority drugs." The Federal Register notice is the second request for comments on an aspect of the generic drug review process within a week. A May 28 notice asked for comments on a generic drug monograph system, another idea proposed by Dingell last year (see following story). "In an effort to improve its generic drug review program, FDA is examining its administrative policies and procedures pertaining to the review and approval of such products," the May 30 notice says. "Should FDA create an administrative process that would expedite agency review of some ANDAs for generic versions of certain important drug products?" the notice asks. The notice specifically requests comments on several issues. "How should 'blockbuster' drugs be identified? When should such drug products be designated?" the agency asks. The notice says that "one possibility" is "to designate any drug whose annual retail sales are greater than some fixed amount, e.g. $ 50 mil." Such drugs "could be identified at some time period, e.g., two years, before the expiration of patent terms and market exclusivity." The notice also asks how an expedited review should work. "Should FDA review all ANDAs and amendments for generic versions of 'blockbuster' drug products before reviewing or approving any other ANDAs and amendments?" it asks. The notice also asks whether ANDAs submitted for a product before it is designated a "blockbuster" should receive expedited review, or just those submitted after designation. In addition, FDA is seeking comments on "the costs and benefits to the public, the agency, and the industry of an expedited review process," and on "what legal issues might arise" from the adoption of an expedited review policy. Finally, "the agency also invites comments on any other aspects of this issue, including alternative approaches that might better ensure the safety, effectiveness, uniformity, and timely approval of generic drug products." The deadline for comments is Aug. 28.

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