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Executive Summary

OUTSIDE REVIEW OF NDAs IS OPPOSED BY 81% OF FDA MEDICAL OFFICERS who responded to a survey conducted by Public Citizen's Health Research Group regarding the drug approval process reforms proposed by the Vice President's Council on Competitiveness. HRG, which is opposed to many of the proposals, sent questionnaires to 121 FDA medical officers. Of the 47 medical officers that responded to the survey, "80.8% [38] disagreed or strongly disagreed with the plan to privatize the review of new drug applications," HRG said in a Dec. 19 press release. "Rather than paying for outside review it makes more sense to expand and improve the agency," one FDAer commented in the survey. "FDA has already 'farmed out' new NDAs but the results have been very disappointing," another medical officer said. To conduct the survey, HRG sent Center for Drug Evaluation and Research medical officers a questionnaire concerning three of 11 proposals announced by the Competitiveness Council on Nov. 13: outside reviews of NDAs, review and approval of IND requests to conduct Phase I trials by local institutional review boards, and FDA acceptance of foreign drug approvals. HRG's survey had a response rate of 38.8%. HRG said it received responses to the survey from medical officers in six of the nine drug reviewing divisions at FDA. The FDA medical officers that responded to the survey were most negative about the proposal to shift the agency's responsibility for reviewing Phase I IND requests to local IRBs. Of those surveyed, HRG noted, "91.5% disagreed or strongly disagreed with the plan to weaken the protection of human subjects of drug experiments by eliminating a key FDA protective role." Many of the medical officer's comments express concern over possible safety risks involved with the IRB proposal. "Not all IRBs have adequately-trained toxicologists to evaluate the potential human toxicities at proposed dosages of investigational drugs," one medical officer commented, according to HRG. "While a few IRBs are capable of making these judgments, many are not," another FDAer commented. "Our division has put on hold a number of inadequate INDs previously approved by local IRBs." Of those responding to the survey, HRG said that "83.5% disagreed or strongly disagreed" with the proposal to base U.S. drug approvals on approvals in other countries. One FDA physician, HRG said, noted that "there is no basis yet for even exploring the possibility of even using an occasional foreign review much less just taking their word for it (i.e. recognizing the decision). It's amusing also that 'recognizing' rejection has not come up, e.g. yanking Halcion because the Brits did." One medical reviewer, Grant Williams, MD, from the Oncology and Pulmonary Drugs Division, criticized the proposal for independent reviews of Phase I INDs in a Nov. 20 letter to Vice President Quayle ("The Pink Sheet" Dec. 2, p. 16). Williams said that over the last two years of reviewing NDAs, he has "noted numerous dangers in applications that were not foreseen by investigators or [IRBs]." On Dec. 11, FDA Commissioner Kessler met with the agency's entire drug review staff to discuss the Competitiveness Council's drug approval reform proposals. According to FDAers, Kessler held the meeting because he did not want people speculating about how FDA will respond to the proposals. Kessler reportedly told the group that FDA has accepted the proposals in principle, but that they will require further consideration and due process. He is understood to have told the review staff that implementation of any of the proposals would be an orderly process and, if regulations are necessary, they will go through normal notice and comment rulemaking procedures. Reportedly, the commissioner said that the idea of outside reviews of NDAs is experimental and that the process of contracting out reviews will take months. Allowing local IRBs to review Phase I INDs will probably require changes in the IRB and IND regulations, he said. FDA first needs to determine what exactly is entailed in the proposal and to ask IRBs if they are interested in taking on this responsibility, Kessler reportedly told the review staff. In addition, Kessler said that the acceptance of foreign approvals may require statutory change, and that FDA is currently concentrating on harmonizing review standards with other countries.

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