Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA MAY REFUSE TO FILE NDAs LACKING DEMOGRAPHIC ANALYSES,

Executive Summary

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.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS022384

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel