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U.S. CLINICALS COULD PROVIDE LIABILITY PROTECTION NOT AVAILABLE TO NDAs APPROVED ON FOREIGN DATA; FDA "BIAS" FAVORS U.S. DATA -- VODRA

Executive Summary

U.S. clinicals could have product liability significance which will continue to make them important to new drug launches even as FDA permits more non-U.S. data in NDA submissions, Arnold & Porter attorney William Vodra indicated in a speech at the Food & Drug Law Institute Pharmaceutical Update meeting in New York on May 12-13. Referring to the provision in the NDA Rewrite regs which allows submission of foreign data as the sole basis -- in some instances -- for FDA approval, Vodra noted that "if you launch a product in the U.S. market without doing one single trial in the U.S., the [question asked by] the jury [is] how much testing you did and whether it was adequate." Product liability defense in the case of products approved on foreign data, Vodra said, "is going to be very difficult to sustain." He added: "You are taking enormous risks with product liability complications without putting together some U.S. experience. Vodra, a former FDA attorney, maintained that an institutional bias against foreign data still exists at the agency. He contended that the remaining bias makes it worthwhile for mfrs. to conduct U.S. clinicals. Vodra also pointed out that U.S. physicians may be reluctant to prescribe a product for which U.S. studies have not been conducted. "World NDA" Doubtful Due To Difficulties In Defining Protocol To Fit All Countries Explaining the revisions in foreign data rules under the NDA Rewrite, Vodra noted that the changes are incorporated into a policy on foreign studies adopted by the agency in 1975. The D.C. attorney said that the procedures for deciding whether foreign data are acceptable fall into a three-tier system. "First," he said, "every foreign study on a drug must be included in the NDA -- whether it's good, bad or indifferent, it must be included." Secondly, Vodra noted that any foreign study must meet the criteria set forth in 1975. The studies must meet the adequate and well-controlled definition; they must be performed by a qualified investigator using adequate records which are available to the sponsor; and they must be performed in accordance with local ethical standards or the Declaration of Helsinki, whichever provide a higher level of ethical protection. Thirdly, they must meet the new NDA Rewrite criteria. Those criteria tighten the definition of a qualified foreign investigator to include the phrase, an investigator of "recognized competence," Vodra said. He noted that FDA will now require that data be valid without the need for an FDA inspection or audit, or that the agency will have the right to gain access to the data or the premises at which the study was performed. According to Vodra, FDA may interpret that rule as permitting the agency to seek on-site inspections of foreign clinical trials. Foreign studies must also be conducted under medical practices reflecting those in the U.S. in order to be applicable to the U.S. population. * Commenting on the prospects for a "world NDA" (an application for marketing approval which would be accepted in numerous countries), Vodra expressed doubt that a common application can be achieved. He noted the difficulties of defining the "architecture" of the testing programs to fit the interests of different countries.

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