FDA Plans to Get Tough On Clinical Trials That Don’t Include Women

WASHINGTON—The FDA has proposed a new regulation that would make sure pharmaceutical companies comply with a 1993 order to include women in all phases of drug testing. An examination of some 4,000 trials done in the last three years showed that approximately one quarter still excluded women of childbearing age solely because they could become pregnant during the trial.

The new rule would allow the FDA to stop or prevent clinical trials of agents for use in serious or life-threatening conditions if they exclude women of childbearing age. The rule would apply even to drugs suspected of causing birth defects. The FDA will decide whether to finalize the measure after a 90-day period for public comment.