美国总审计局批评FDA对性别特异药物资料的疏忽
NEW YORK (Reuters Health) - The US Food and Drug Administration (FDA) has failed to adequately oversee the presentation and analysis of gender-specific data in the drug development and approval process, according to a new report from the General Accounting Office (GAO).
The GAO said that its criticism held true despite the fact that more women than men participated in the clinical trials for the 36 new drug applications reviewed in the report. While women made up about 55% of the patient population in late-stage studies, only about 22% of patients in early safety and tolerability studies were female, the report notes. The NDAs were filed between 1998 and 2000.
Even when sufficient data is gathered in female populations, "[t]he FDA's medical officers have not been required to discuss sex differences in their reviews of new drug applications, and we found that many of them have not done so," the GAO added. "Furthermore, even though about one-third of new drug applications specified that the concentrations of the drug in the bloodstream were greater in people who weighed less, such as women, FDA reviewers did not comment in their summaries on the lack of dose adjustments based on sex."
The report goes on to point out that the FDA does not have adequate systems in place to monitor how many women are in clinical trials to ensure that drug developers are in compliance with regulations for presenting gender-related clinical outcome data.
In response, the FDA said it has begun to take steps to address the problems--including development of demographic worksheets to gather information on the sex of study subjects and a template that requires reviewers to discuss sex differences.
The agency added that its Office of Women's Health is developing a demographic database to monitor the inclusion of women in drug studies, as well as to track other demographic variables that might affect drug evaluations, such as race and age., 百拇医药
The GAO said that its criticism held true despite the fact that more women than men participated in the clinical trials for the 36 new drug applications reviewed in the report. While women made up about 55% of the patient population in late-stage studies, only about 22% of patients in early safety and tolerability studies were female, the report notes. The NDAs were filed between 1998 and 2000.
Even when sufficient data is gathered in female populations, "[t]he FDA's medical officers have not been required to discuss sex differences in their reviews of new drug applications, and we found that many of them have not done so," the GAO added. "Furthermore, even though about one-third of new drug applications specified that the concentrations of the drug in the bloodstream were greater in people who weighed less, such as women, FDA reviewers did not comment in their summaries on the lack of dose adjustments based on sex."
The report goes on to point out that the FDA does not have adequate systems in place to monitor how many women are in clinical trials to ensure that drug developers are in compliance with regulations for presenting gender-related clinical outcome data.
In response, the FDA said it has begun to take steps to address the problems--including development of demographic worksheets to gather information on the sex of study subjects and a template that requires reviewers to discuss sex differences.
The agency added that its Office of Women's Health is developing a demographic database to monitor the inclusion of women in drug studies, as well as to track other demographic variables that might affect drug evaluations, such as race and age., 百拇医药