Oct. 6, 2000 (Washington) -- The FDA's approval of RU-486, or Mifeprex, has renewed the abortion issue as a topic of national debate and highlighted abortion as a presidential campaign issue. But mixed in with discussion of the approval of RU-486 are a number of myths:
Myth #1 -- The FDA timed the approval to become an issue in the presidential campaign.
Not so. The FDA had to decide on whether to approve or reject RU-486 by the end of September of this year because the law requires the agency to make approval decisions within certain time frames. It just so happened that the time frame expired in the midst of the campaign.
That's not to say that the FDA did not recognize the implications of its decision. What has not been widely reported is that the FDA itself, under its former Commissioner David A. Kessler, actually initiated the RU-486 approval by asking its manufacturer to submit the application. I can't recall any other instance in which a FDA Commissioner has invited a drug company to apply for a specific product approval.
The approval of a new abortion option had a lot of support within the FDA staff, but they tried to make the decision on the basis of the scientific data demonstrating RU-486's safety and efficacy.
Myth #2 -- The approval of RU-486 can easily be reversed by the next presidential administration.
Not so. Even though the FDA reports ultimately to the White House, a drug approval has a legal standing that cannot be simply and quickly overturned. For RU-486 to be taken off the market, the FDA would have to go through a lengthy legal/administrative process that could take years.
The reason that some drugs, such as the weight loss drug Redux, have come off the market so quickly was because manufacturers usually voluntarily withdraw drugs that the FDA deems unsafe. The manufacturer of RU-486 would not be so cooperative with an anti-abortion rights administration, and if an effort is made to remove the drug, a legal and lengthy fight is likely to ensue. Thus, if George W. Bush, who has expressed opposition to RU-486's approval, were to be elected president, and were he to seek removal of RU-486, he cannot do it on command.
There are two other options that RU-486 opponents could pursue that would lead to its removal from the market. One is that a new Secretary of Health and Human Services could declare RU-486 to be an "imminent hazard" to the public health, which would enable the government to summarily prohibit its sale. The second is that Congress could pass a law prohibiting sales of RU-486. I think both of these courses of action are unlikely, but they're really the only political outlets that the RU-486 opponents have.
Myth #3 -- Any doctor can prescribe RU-486.
Not so. While generally any licensed physician can prescribe any approved drug, the FDA requires that physicians who want to prescribe RU-486 be trained in how to administer it, provide detailed counseling to the patient, and be able to perform or arrange for a surgical abortion should RU-486 fail. In other words, physicians who intend to prescribe RU-486 must seek training.
It remains to be seen how many physicians will seek training and choose to be identified as capable of prescribing the new drug since the politics of abortion remain intense.
Myth #4 -- RU-486 will be less expensive than a surgical abortion.
Perhaps not. Medical costs are variable, but national averages are that a surgical abortion costs $300 and RU-486 will cost about the same. There are also costs of office visits and counseling. It remains to be seen what the ultimate cost is, but it's not likely to be significantly different from the cost of a surgical abortion.
Myth #5 -- RU-486 will be much more convenient than a surgical abortion.
That depends on a number of factors. The reality is that a surgical abortion can be accomplished in a single visit to a clinic or hospital, with follow-up checks as needed. RU-486 requires at least three visits to a physician's office or clinic, spaced over a two-week period. There does not appear to be a major advantage in convenience, at least in terms of numbers of visits to the physician.
In summary, RU-486 certainly provides a new option for women seeking to terminate a pregnancy. It also provides a new topic of debate in this political season. Now it's up to physicians to decide whether they want to be trained in how to use it, and it's up to women to decide whether they want to use it.
Wayne L. Pines, WebMD's Washington columnist, is a former associate commissioner and chief spokesman of the Food and Drug Administration. The opinions expressed in this article are not necessarily those of WebMD.