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INVESTIGATIONAL NEW DRUG OUTSIDE REVIEW BOARDS

Executive Summary

INVESTIGATIONAL NEW DRUG OUTSIDE REVIEW BOARDS should be accountable to FDA, "not Congress or some other organization," the Pharmaceutical Manufacturers Association stated in April 20 comments to FDA. PMA's subcommission was in response to a series of questions FDA posed in the final IND Rewrite rule, published March 19 in the Federal Register, regarding the desirability of conducting a pilot test of outside review boards (ORBs). In the preamble to the IND reg, FDA said it was considering a pilot program under which drug sponsors would have the option of submitting their Phase I IND research proposals to either FDA or independent ORBs. In response to FDA's question as to what legal liability ORB members or their affiliated institutions would have for the consequences of ORB decisions, PMA asserted that the liability "should be no greater than the liability of the FDA under the same circumstances." The association stated that "if the liability protection enjoyed by FDA cannot be extended to the ORBs, sponsors who submit applications to ORBs could be required to indemnify the ORB." PMA suggested that the pilot program last for an initial period of one year and "encompass a diverse sample of the drug population," rather than concentrate on any single category of drugs. As to which institutions, organizations or other entities should be involved in the pilot program, PMA said "major medical centers, which already conduct substantial amounts of IND work, would probably be the most logical candidates." FDA asked what its ORB monitoring responsibilities, if any, should be in ensuring no conflict of interest among ORB members and in evaluating the INDs under consideration. PMA responded that FDA should at least initially review all the data submitted to the ORB. "Should a situation arise in which the ORB had permitted a study to go forward which the FDA concludes should not have gone forward, this would provide an occasion to raise questions regarding possible conflict of interests, etc.," PMA stated. "If, as PMA believes would be the case, there will be few if any cases in which FDA's judgment is different from the ORB's judgment FDA could, as it grew comfortable with the system, eliminate its own routine review of the data submitted to it," PMA stated.
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