Sponge Bath

How the FDA squeezes women's choices

Michael Fumento from the June 1995 issue

(Page 2 of 2)

For all its concerns, the FDA is no guarantee of safety, even within the field of contraceptives. For instance, the FDA tested and approved the Dalkon Shield, an intrauterine birth-control device that killed 18 women and injured thousands more before being pulled off the market in 1975. Similarly, the tampons responsible for toxic-shock syndrome met all FDA regulations.

The FDA's stock reply to such examples is that but for them, there would be even more such deaths. But that's an inherently unbalanced equation. After all, a product that is forbidden to be sold cannot possibly cause harm. If delayed several years, it cannot cause harm in those years. But neither can it help--and the lives lost because of held-up drugs and devices need to be factored into any serious cost-benefit analysis.

The Today Sponge incident adds another factor to this already deadly equation: It turns out that the full impact of the FDA's regulatory myopia is not just revealed in preventable deaths, but perhaps in preventable births, as well.