FDA MAY REFUSE TO FILE NDAs LACKING DEMOGRAPHIC ANALYSES,
FDA MAY REFUSE TO FILE NDAs LACKING DEMOGRAPHIC ANALYSES, Center for Drug Evaluation and Research Director Carl Peck told the Pharmaceutical Manufacturers Association in a March 31 letter. The agency said it is enlisting PMA "to convey to [its] members [FDA's] expectations so that the needed analyses will be performed before the application is submitted." FDA drug divisions have been notified to screen NDAs for analyses by gender, race and age and request analyses that are missing, Peck noted. If an NDA does not contain the analyses, "the division will request that sponsors provide the appropriate analyses promptly," Peck said. "If they cannot, refusal to file will be considered," the center director warned. NDA reviewers "have been urged to note in their reviews the presence of these analyses, to comment on their adequacy and findings, and to formulate a conclusion about clinical relevance, labeling implications, and the need for further investigation," Peck said. The presence or absence of the analyses should be assessed by the 45-day filing meeting, reviewers have been told. The letter to PMA follows by one week FDA Commissioner Kessler's release of information on the agency's proposed guideline on gender differences, emphasizing the importance of data evaluation by gender ("The Pink Sheet" March 29, T&G-7). The proposed guidance also encourages the enrollment of more women in clinical trials, including Phase I and Phase II. In the letter, Peck noted that despite the 1988 "Guideline for the Format and Content of the Clinical and Statistical Sections of New Drug Applications" that calls for every NDA to include analyses by gender, race and age, a Government Accounting Office survey of NDAs approved between 1988 and 1991 found that less than half contained gender analyses ("The Pink Sheet" Nov. 2, 1992, T&G-4). Peck added, however, that FDA was not convinced that there was a problem because many of the NDAs in the GAO study would have been submitted prior to the 1988 guidelines. Therefore, FDA initiated its own internal survey of NDAs submitted after July 1991. "To our surprise and disappointment, our findings were very similar to GAO's," he said. In a Jan. 11 memo to the drug divisions, the example of Pfizer's Norvasc (amlodipine), approved in July 1992, is cited as a case in which gender analysis affected labeling. The drug was found to cause edema and flushing in women three times as often as men and palpitations twice as often. "It is perhaps of interest that the sponsor of amlodipine submitted age and race analyses, but not (initially) a gender analysis; that had to be requested," the memo states.
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