FDA to mandate women in clinical trials
Stating that its four-year promotion of voluntary inclusion of women in clinical studies is not working, the U.S. Food and Drug Administration says it will begin insisting that women be included in trials of serious and life-threatening diseases.
In 1993, the agency deemed that women of child-bearing years could be included based on informed consent, but according to FDA deputy commissioner Mary Pendergast, "We have tried to jawbone companies to include women, but fully one-quarter of trials continue to automatically and systematically exclude women. The voluntary system wasn’t working successfully enough."
Now, while the agency will not set quotas for female inclusion, it will use its power to delay trials until officials are satisfied with the trial’s protocols. The new procedure mainly will deal with including women who are already sick and not pregnant. Gender-specific trials on males will be allowed to continue, as long as female-only trials also are conducted when appropriate.
The FDA set up a 90-day period of comment on the new policy beginning Sept. 24, after which a final proposal will be filed.
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