Proposal: don't exclude women from drug studies

FDA Consumer, Jan-Feb, 1998

A rule proposed by FDA aims to

ensure that women of reproductive age are

not automatically excluded from studies

of drugs and biologics for treating

life-threatening diseases such as AIDS.

If made final, the rule would permit

FDA to stop a company from conducting

or continuing a study if women or men

were being inappropriately excluded

based only on the risk of damage to their

reproductive organs or to the health of

potential offspring. It would not apply to

certain studies, such as those designed to

look only at healthy volunteers or to test

drugs for use exclusively by one gender,

such as prostate cancer drugs.

FDA wants to expand access to new

treatments for life-threatening diseases,

believing that patients and their doctors

can themselves weigh the risks and benefits

of such treatments when given

complete information during the

informed consent process.

The agency hopes that diversity in

drug studies will provide better information

about how the drug will affect the

people who will use it.

The proposed rule, published in the

Sept. 24, 1997, Federal Register,

provided a public comment period that

ended Dec. 23.