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Executive Summary

CLINICAL TRIAL INVOLVEMENT BY FDA AT EARLY STAGES WILL BE LIMITED, Office of Drug Evaluation and Review I Director Robert Temple told a group at the Thirty-Second Annual Educational Conference of the Food Drug and Law Institute on Nov. 29. "I don't see [FDA] as routinely trying to design Phase I and Phase II [studies]," Temple said. Recent passage of the interim rule, which mandates pre-IND and early Phase I consultations between FDA and the sponsors of drugs for the treatment of life threatening diseases, Temple noted, has raised the question as to "whether this is the likely course of all drug development." "One can see the recent interim rule as the next step moving into Phase I and Phase II to provide a sort of cradle-to-grave guidance on how to work up drugs," Temple commented. The interim rule for breakthrough products was published in late October ("The Pink Sheet"; Oct. 24, p. 3). However, Temple cited a lack of FDA resources as one impediment to extensive FDA involvement in early clinical trials. Furthermore, the "healthy diversity" that is present in the early stages of drug development may be impaired by greater FDA involvement. "I am somewhat uncomfortable with too much monolithicity, too much advice coming from one place," Temple said. Although restrictive intervention by FDA should be discouraged, early consultation in certain situations is important, Temple noted. "When Phase II can be the whole database then it is important to have early agreement on what the accurate data will be," Temple remarked. Another situation where early consultation would be beneficial is in the case of drugs with difficult efficacy tests such as drugs for dementia. Temple assured the FDLI meeting that the level of clinical holds on drugs at FDA has not increased since the onset of the IND Rewrite reg. The relative number of holds has remained the same over the last eight or nine years, he maintained. "After a fair amount of effort, [FDA] found that there hadn't been any change" in the frequency of holds, Temple reported. The number of applications put on clinical has remained constant at a level of 10%. Last July, Temple's assistant Linda Carter announced that FDA was checking into reports that clinical trial holds had increased as a result of the IND Rewrite ("The Pink Sheet" July 25, T&G-4).

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