@Espiritus_Corvus, I’m glad you asked!
Since you mentioned the FDA, let’s start there. In the 1970s, the FDA actually recommended that women who may become pregnant (so, any woman of childbearing years) should be excluded from research studies completely (pdf). This guideline was not revised until 1993 (pdf). As a guideline, however, it was not a law. No actual laws were created until 1998, at which time the FDA required drug studies to report the number of men and women in their study—not to balance the numbers, or even to analyze the two groups separately!
Since the 1993 report, the number of women included in research studies has steadily increased. However, there is little oversight and compliance is poor. From a 2001 report to Congress: “There is no management system in place to record and track the inclusion of women in clinical drug trials or to monitor compliance with relevant regulations, so FDA is unaware that many new drug application submissions failed to meet standards.” The same report found that even when sex differences were actually found and different dosage recommendations should be made, the investigators in every case failed to make this distinction.
And even with these recommendations, drugs that survive clinical trials and are put on the market tend to be more dangerous for women. Of the ten prescription drugs withdrawn from the market between 1997 and 2001, eight of them were more dangerous for women.
So that is the FDA. Consider also that this is the last stop for drug development, which does not encompass all medical research. I don’t have a source for this, but as a research scientist I would estimate that more than 99% of medical research does not make it to the FDA. (Because it fails. Science is mostly a long string of failures.) So I do not think that regulating research at the level of the FDA is sufficient.
Since most medical research in the US is funded by the National Institute for Health, you might think this would be a good place to regulate the study of sex differences in medical research. In 1990 they established the Office for Women’s Health Research to encourage this. But equal investigation of men and women (or male and female animals) is still not a requirement of NIH-funded research.
Also, from a report by the Institute of Medicine: ”...a recent review of high-impact publications of clinical studies, including clinical trials and prospective cohort studies, of non–sex-specific cancers… found that women constituted less than 40% of participants (Jagsi et al., 2009). Other research indicates that studies of cardiovascular disease are particularly male-biased. A review of 19 randomized controlled cardiovascular trials found that only 27% of the participants were female and that only 13 of the studies presented sex-based analyses of the data.”
Let me conclude by telling you an anecdote about my own research. In 2006 I started taking birth control pills. I noticed some subtle changes to my memory, verbal fluency, and other cognitive functions, so as a recent college graduate with some knowledge of the brain and of research, I thought I would look up whether or not birth control actually affects any cognitive functions, or if I was just imagining things.
What I found was that as of 2006 fewer than ten studies had ever been done on the effects of birth control on cognition. This is a drug that 100 million women in the world use, and effects on memory, attention, perception, learning, and every other important behavioral trait were almost entirely unexplored. So in 2011 I co-authored a paper showing significant differences in memory in women using hormonal contraception.
As you can see, I think this is a very important issue. We have made a lot of progress recently, but there is a lot left to do.
Finally, let me refer you to a 2010 report on this issue from the National Academy of Sciences. Please let me know if you would like to see more sources.