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EXPEDITED ANDA REVIEWS FOR "BLOCKBUSTER" DRUGS WOULD ALLOW "BUNDLED," PROSPECTIVE APPROVALS, ACCORDING TO DINGELL CHANGES TO ANDA REVIEW PROCESS

Executive Summary

The establishment of formal expedited approval procedures at FDA for major brandname drugs coming off patent is one of the key recommendations for ANDA changes from House Energy & Commerce Committee Chairman Dingell (D-Mich.). In an April 6 letter to FDA Acting Commissioner Benson, Dingell advised the agency to modify its "first-in, first-reviewed" policy "to permit expedited review of the ANDAs for the 'blockbuster' drugs coming off patent over the next five years." The Michigan congressman envisions a process whereby FDA would expeditiously review ANDAs for big-selling prescription drugs prior to those products' patents expiring. That way, Dingell noted, FDA would "have in place multiple approvals of ANDAs as the [brandname] drugs come off patent." The multiple competition forces down the price of the product much more rapidly than a generic "exclusive." The approach recommended by Dingell was informally adopted by FDA's generic division after Waxman/Hatch for several major products, including Wyeth-Ayerst's Inderal and Roche's Valium. In fact, FDA has been criticized in the past by the generic industry for "bundling" ANDA approvals. Dingell asked FDA "quickly" to take steps to meet this "special priority." He suggested that FDA publish a Federal Register notice " soliciting suggestions as to which drugs should receive this special priority among those coming off patent in the next five years, as well as criteria for automatic priority drug designation in the future." FDA, Dingell added, "should not await the development of such guidelines to begin work on the obvious priority drugs." * The letter to Benson includes a list of "major" drugs due to come off patent by 1995 that, according to Dingell, may fit such an expedited ANDA procedure. The list includes Pfizer's Procardia and Feldene, ICI's Tenormin, Marion Merrell Dow's Cardizem and Seldane, Lilly's Celcor, Bristol-Myers Squibb's Capoten and Corgard, Ciba-Geigy's Lopressor, Syntex's Naprosyn, Upjohn's Xanax, SmithKline Beecham's Tagamet and Glaxo's Zantac. One very significant change in FDA's current generic review process recommended by Dingell is the replacement of the ANDA system with a monograph system similar to that used for OTC drugs and generic antibiotics. A monograph system was proposed for prescription drugs during the Carter Administration but was not acted upon by Congress. "Under this approach," Dingell wrote Benson, "the FDA would develop such monographs for products now in the pipeline and require innovator companies to develop such monographs as a condition of NDA approval for future drug products." Dingell suggested that such a system "appears feasible, would likely improve the quality of generic drugs, and would minimize the incentive for payoffs and fraud." Dingell highlighted the impact a monograph system would have on eliminating inconsistencies among reviewers in approval times for ANDAs. Dingell also highlighted his recommendation that FDA develop "meaningful regulatory definitions and procedures for narrow-therapeutic-range and difficult-to-manufacture generic drugs" due to the potential health consequences for poor bioequivalence or misbegotten approvals in this area. Dingell declared: "The agency review of ANDA applications for these drugs must leave no room for error." In addition, Dingell also suggested that FDA inspect facilities of generic drug manufacturers prior to granting ANDA approvals, tighten requirements and inspections of contract lab facilities, require "spot checks" of documents to look for changes in formulations or manufacturing processes, and improve the post-marketing surveillance of generic drugs. Outside the compliance area, Dingell recommended that FDA reorganize the Office of Generic Drugs along drug specialty areas -- something the agency already has begun to do ("The Pink Sheet" April 2, T&G-12) -- and dedicate specific reviewers to look at ANDA supplements in lieu of "supplement weeks."
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