Marla Ahlgrimm Discusses FDA Role in Women’s Health

The US Food and Drug Administration was established in 1906 to promote better health practices for all persons, says Marla Ahlgrimm. Since then, this division of the US Dept. of Health and Human services has touched women’s lives in unique ways. Ahlgrimm explains how in this brief Q & A.

Q: What does the FDA regulate?

Marla Ahlgrimm: The FDA’s role is constantly changing to adapt to scientific discoveries as well as in response to issues that affect people’s health. Currently, the agency oversees the safety of food, medical devices, pharmaceuticals, devices that emit radiation (televisions, microwaves, etc.), cosmetics, tobacco products, and vaccines.

Q: How did the FDA help change the status of women’s reproductive rights?

Marla Ahlgrimm: In the 1960s, the FDA approved the first oral contraceptive. This marked the first time in history a woman could take charge of her ability to prevent pregnancy. This is one of the biggest milestones in women’s sexual health in the last 200 years.

Q: What is the Medical Devices Amendment?

Marla Ahlgrimm: In 1976, in response to an alarming number of women seriously injured after using the Dalkon Shield IUD, the US Government passed the Medical Devices Amendment. This broadened the FDA’s authority over medical devices and led to the approval of the first home pregnancy test. Advances in mammography screening and STD tests also resulted.

Q: What simple FDA requirement is credited for saving dozens of women’s lives each year?

Marla Ahlgrimm: Prior to 1980, women using tampons were at a greater risk of developing Toxic Shock Syndrome, or TSS. In that year, there were greater than 800 confirmed cases of TSS and 38 deaths. The FDA concluded that it was the lack of information regarding tampon use that led to these tragedies and passed a bill requiring that all tampon manufacturers include a small educational pamphlet in each box of tampons sold in the United States. By 1997, TSS was nearly eradicated, with only five cases and zero deaths reported that year.