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Executive Summary

BIOBATCH RETENTION COSTS $100,000 PER YEAR, FDA ESTIMATES in the final rule on "Retention of Bioavailability and Bioequivalence Testing Samples" published in the Federal Register April 28. "The agency's assessment presents costs of retaining samples for an estimated 360 marketing applications per year," FDA said. "Although individual circumstances may arise where storage or acquisition costs for a particular sample could rise substantially above these estimates, the agency believes that, on average, the annual costs of this rule will be about $100,000." The April 28 final rule is essentially similar to an interim rule that has been in place since Nov. 7, 1990 ("The Pink Sheet" Nov. 12, 1990, T&G-9). The rule, adopted in the wake of the discovery that some generic drug firms had submitted innovator products for bioequivalence testing, requires sponsors and contract testing firms to keep samples of drug used in bioequivalence or bioavailability testing for five years. The samples must be large enough "to permit FDA to perform five times all of the release tests required in the application or supplemental application." Several comments on the interim rule cited cost as a reason for reducing either the amount of drug in the reserve samples or the time such samples are required to be kept, FDA noted. The agency, however, "believes that these costs will likely be more than offset by the societal benefits of this rule, i.e., the added assurance that FDA's drug approval process functions effectively." In rejecting suggestions that the retention period be shortened to two or three years, FDA said that since it does not conduct preapproval inspections (where the samples would be collected) for all applications, any substantially shorter retention period would not allow the agency to recover samples if questions arose after approval. As to the quantity retained, "FDA's experience in the testing of reserve that the five times quantity required for the test article and the reference standard is needed to perform necessary testing." The agency is requesting more information on the relative costs of retaining samples for shorter periods of time and of retaining smaller sample sizes. FDA also is requesting "any information on the incremental benefits of either retaining greater quantities of samples, or of retaining samples for greater periods of time." The comment deadline is May 28. Specific changes to the final rule include: clarification of the types of bioavailability and bioequivalence trials for which samples must be retained; an explicit requirement that reserve samples be stored "in an area segregated from the area where testing is conducted and with access limited to authorized personnel"; and a requirement that contract testing firms turn retained samples over to "an appropriate, independent third party" -- rather than the sponsor -- if the testing firm goes out of business during the five-year retention period.

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