FDA’s Patronizes Women with RU486 Restrictions

A couple months ago, I wrote about the U.S. Food and Drug Administration dragging its feet in approving the abortion pill RU-486 (|FDA vs. Women’s Health, Again|.) When he was running for president and needed women’s votes, Bill Clinton promised swift approval of RU-486 if he were elected. Of course once in office, Clinton forgot about his promise and, if anything, the Clinton FDA approach to RU-486 was far worse than the Reagan administration approach (at least the Reagan administration was frank enough to admit its ideological opposition to RU-486).

Now word comes from on high that the FDA is finally ready to approve RU-486. Unfortunately it is going to attach a set of unprecedented conditions that may make illegally smuggling the drug into the U.S. more viable than getting the drug via prescription.

First, the FDA wants all physicians who prescribe RU-486 to be part of a national registry of abortion pill providers. What genius at FDA thought this would be a good idea? Is it possible they’ve been so busy finding excuses not to approve the drug that they’ve missed the wave of anti-abortion violence directed against clinics and doctors over the past 20 years? The creation of a national registry is an open invitation for violent anti-abortion extremists.

Second, the FDA wants to limit the doctors who can prescribe RU-486 to just those doctors who are also qualified to perform surgical abortions. In addition the doctors would be required to hold admitting privileges to a hospital within one hour’s drive of their office. According to the FDA, the justification for this rule is that if RU-486 should not cause an abortion, the woman’s physician will be able to perform a surgical abortion. This is downright bizarre. My wife has chronic back pain and went to her physician for a pain killing prescription. Under the FDA’s logic, however, only a physician qualified to do back surgery should be allowed to write prescriptions for back pain. Women are clearly resourceful enough in this day and age to find a physician to perform a surgical abortion if RU-486 fails.

Finally, the FDA unbelievably wants to create some sort of system to track women who take RU-486, which it says is necessary to track any possible side effects from the drug.

The reality is that, again, the FDA seems more likely to be interested in presidential politics, not wanting to inject the RU-486 issue as an issue in the upcoming election. This is a drug that has been used safely and successfully in Europe for decades now — the requirements to limit and track who can prescribe the pill are completely unwarranted, as is the tracking of patients, considering the drug’s track record in Europe. As Dr. Michael Creinin of the University of Pittsburgh told CNN, “The FDA is creating a whole new standard with these restrictions” (FDA approval of abortion pill linked to stringent conditions).

The FDA should stop its shameful delaying tactics and approve RU-486 with all possible haste. Leave it to the Clinton administration to play politics with women’s health and reproductive choices.

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