Word: fda
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...mifepristone's defenders counter that carrying a baby to term is six times as dangerous as ending a pregnancy, whether surgically or medically. There are certainly risks if women were to use the drug without adequate supervision, but the FDA guidelines aim to limit that possibility: a patient will receive written instructions on taking the pills, and must sign a statement swearing that she has read them and that she will agree to a surgical abortion if the medication fails...
Though the abortion debate could now land squarely back in the middle of the presidential campaign, both candidates mainly used last week's announcement to reinforce longstanding positions. While the next President can't reverse the FDA outright, he could pick an FDA commissioner and a Health and Human Services Secretary who would raise safety questions and try to tighten distribution--with the goal of making medical abortion just as hard to get as surgical abortion...
...mainstream medicine come from two very different worlds and operate in different regulatory environments. The marketing of prescription and over-the-counter drugs is strictly regulated by the Food and Drug Administration, which requires scientific proof of safety and efficacy. Herbal remedies, by contrast, are largely exempt from FDA supervision. Companies can sell herbal preparations without guaranteeing that what's on the label is inside the bottle...
...FDA's rules are actually less restrictive than many of those found in Europe. In Britain the pills are available only in licensed abortion facilities--usually clinics and National Health Service hospitals--and must be taken on the premises. Similar regulations exist in France, which requires four visits over a period of three weeks to a licensed hospital or clinic. Dr. Elizabeth Aubeny, one of the first physicians to test mifepristone, at the Broussais Hospital in Paris, contends there should be more flexibility in allowing women to take misoprostol at home, if they choose. Still, she admits, "there...
...FDA's approval of the abortion pill, once known as RU 486, came after two decades of research, protests and political controversy...