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ACCELERATED DRUGS SHOULD BE DEEMED FULLY APPROVED IN 180 DAYS

Executive Summary

ACCELERATED DRUGS SHOULD BE DEEMED FULLY APPROVED IN 180 DAYS after submission of follow-up studies to FDA, unless the agency acts upon the application within that time period, Merck Research Labs recommended in July 15 comments on FDA's proposed rule to establish an accelerated drug approval procedure. Merck suggested that such a deadline would ensure that confirmatory studies are reviewed in a timely manner. If FDA does not act on an application for 180 days, Merck said that the product should be freed from the marketing and distribution restrictions contained in the rule, such as that a drug approved under the accelerated process may be distributed only to certain physicians. FDA proposed the regulation April 15 ("The Pink Sheet" April 20, p. 8). Under Merck's recommendation, an accelerated approval process drug that is deemed approved after 180 days would have the same status as a drug approved by standard procedures. If "FDA has not yet acted upon the application" within 180 days, the NDA should "be deemed approved as if by 'traditional' procedures and all other provisions of the [FD&C] Act should apply, e.g., [a] product must have a hearing before removal from the market," the company suggested. The proposed reg would permit FDA to remove an accelerated approval drug from the market under a "streamlined" procedure. Merck's rationale is that there "appear to be no incentives for FDA to remove the restrictions imposed by provisions of this accelerated approval rule...after all data from follow-up or confirmatory Phase III studies have been submitted in a supplementary [NDA]." Merck called the 180-day period "reasonable" because "it is presumed that FDA staff will be very familiar with the results of the Phase III data" for an accelerated approval product. Merck concluded that, "given severely restricted resources at FDA compounded by a burdensome workload, FDA may not be moved to expedite approvals (without restrictions) for such supplements" unless a time limit is imposed. Merck criticized the proposed regulation's requirement that companies must submit for FDA's review all promotional materials for a drug that received accelerated approval. The requirement is "overly burdensome for FDA" and will "unnecessarily slow down the process for review of all promotional materials," not just those for accelerated approval products, Merck contended. It proposed instead that "FDA only request for review the primary advertising pieces, such as the introductory letter to physicians, the main detail piece and the main journal advertisement." Merck also proposed a 30-day timeframe for FDA's review of the promotional materials. Merck's other objections to the proposed regs were similar to those expressed previously by other firms and trade organizations. For example, Merck asserted that the restrictions on drug distribution outlined in the proposed regs are not legally enforceable and should be limited "to those which may be imposed via labeling." The company said: "The label language can be sufficiently restrictive as to prevent or preclude use by physicians who may not be adequately trained or certified to carry out specified medical procedures." Similarly, the Pharmaceutical Manufacturers Association said in its separate comments on the rule that direct restrictions on distribution of accelerated approval drugs is beyond the scope of the FD&C Act and that all concerns surrounding such drugs could be handled within FDA's current authority and policies ("The Pink Sheet" July 27, p. 8). The Industrial Biotechnology Association suggested in July 15 comments that drugs for which there are no accepted surrogate efficacy endpoints should still be eligible for accelerated approval if FDA would initially accept "a less rigorous standard of statistical significance -- e.g., [values of] 0.20 or 0.15 instead of 0.05." IBA said that such a lowering of statistical norms would be "totally consistent with FDA's willingness to accept greater uncertainty in approving drugs for serious and life-threatening illnesses." After approval, "the sponsor could then complete post-marketing studies to establish statistical significance at conventional levels."
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