The Pill That's Roiling US Drug Regulation

The hard right is challenging FDA's authority to regulate drugs with its lawsuit to ban America's most used abortion pill

THE FUSS is over a pill-an abortion pill that has been used safely for nearly a quarter-century, but has now become a political, medical, legal and regulatory hot potato. It's an intense legal battle with profound ramifications. Not only is it leading to more vociferous protests and campaigns in a society deeply divided on the matter, but it is undermining the very basis of regulation by an independent federal agency in the US.

The case that is roiling the US is a suit by a group of doctors who are seeking to curtail the availability of the nation's most used abortion drug, mifepristone. Approved in 2000 by the US Food and Drug Administration (FDA), its usage has increased steadily over the decades after it has proven to be safe and effective. According to the Guttmacher Institute, a non-governmental organisation that promotes reproductive rights worldwide, there were approximately 642,700 medication abortions in the US last year, accounting for 63 per cent of all abortions in the formal healthcare system. The numbers would be higher since the institute did not take into account the usage outside the formal system. In combination with misoprostol, the two-drug regimen is the most widely prescribed abortion therapy. As such, millions of women are anxious about the outcome of the doctors' lawsuit, as is FDA, since a hard right judiciary has passed orders that undercut its role in approving drugs and setting the rules for their usage.

The anti-abortion doctors and organisations in this suit claim participating in the care of women who have resorted to the use of the abortion pill "to end the life of the embryo or foetus would cause them emotional and moral harm". And how would this occur? They say there would be moral harm because patients who take abortion pills might seek treatment afterwards at emergency departments in hospitals where the doctors work.