The time to regulate RU-486 is now
By Legal Staff
Wednesday, February 16th, 2011

“Telemed abortions” have made headlines in the last year, and with that attention AUL has received numerous requests from state legislators and policy groups seeking to curb the practice. While this issue is so “hot,” states have the perfect opportunity to protect women by regulating the provision of abortion-inducing drugs.

Abortion Providers Misuse Abortion Drugs

Planned Parenthood and abortion providers misuse RU-486, and they do not hide this misuse. In at least two courts and in multiple media outlets, abortion providers have admitted to providing RU-486 to women well outside the directions contained in the drug’s label.

For example, RU-486 is only to be used until 49 days gestation and has no other approved use during pregnancy.  Even at 49 days gestation, the drug has an 8 percent failure rate.  When the drug regimen fails, a woman is then forced to have a surgical abortion (and faces all the risks a surgical abortion entails). The farther along in gestation a woman is, the more likely it is that RU-486 will fail; it is generally understood that there is a 17 percent failure rate at 50-56 days, and a 23 percent failure rate at 57-63 days.

In addition to the heightened risk of failure (and subsequent surgical intervention), abdominal pain, nausea, diarrhea, and vaginal bleeding also increase with advancing gestational age.

But Planned Parenthood openly acknowledges on its website that it provides RU-486 to women up to 63 days gestation—i.e.,  Planned Parenthood admits to providing RU-486 in a way that fails 23 percent of the time.

Of course, if a woman is provided RU-486 at 63 days gestation and it fails, Planned Parenthood will then get her for the second (surgical) abortion. It’s an ingenious profit-making scheme—at the risk of women’s lives. Of course, recent video releases by Live Action confirm that protecting young women does not appear to be high on Planned Parenthood’s agenda.

ACOG Promotes Misuse of RU-486

The Mifeprex (RU-486) drug regimen consists of two rounds of oral drugs (mifepristone on day 1, and misoprostol on day 3). However, the American College of Obstetricians and Gynecologists (ACOG)—in a clear deviation from the drug’s label—recommends that misoprostol be used vaginally instead of orally. ACOG promotes this misuse under the guise of effectiveness; arguably, the RU-486 regimen is more effective at terminating the pregnancy if misoprostol is taken vaginally.

However, vaginal use is dangerous, and the Food and Drug Administration (FDA) has stated that vaginal use has not been proven to be safe and effective. Instead, in many of the complications reported to the FDA, misoprostol was administered vaginally. In fact, of the 8 known RU-486 deaths reported in the United States, 7 of those women had used the ACOG-promoted vaginal use of misoprostol.

Regulating according to the “FDA Protocol”

AUL has drafted model legislation that not only ensures that physicians are present and examine a woman before providing abortion drugs, but also requires abortion providers to abide by the protocol tested and approved by the FDA. In addition, all abortion-inducing drugs (and not just RU-486) are regulated.

Specifically, AUL’s model requires physicians administering “abortion-inducing drugs” (including RU-486) provide such drugs only in the way approved by the FDA and outlined in the drug’s label.

First, such a regulation provides specific guidance to abortion providers on how a drug is to be used. By pointing to a drug label, there is no reason for an abortion provider to not know what is expected of him or her. In the case of RU-486, it will ensure that the drug regimen is only provided until 49 days gestation and administered orally.

Second, requiring that physicians follow the procedure outlined in a drug label ensures that states are regulating to the maximum potential. While a state cannot provide more restrictions on an abortion drug than the FDA has outlined, it can at least ensure that an abortion provider follows the FDA’s approved regimen—and as outlined above, there is court-documented evidence proving that abortion providers are not abiding by that protocol.

Third, it is important to address the difference between an “FDA standard” and a drug’s label. “FDA standard” is a rather vague term and can mean any number of things; but by requiring abortion providers to refer to the drug’s actual label, they are being directed to a specific set of guidelines that have been tested in a clinical setting.

The bottom line is that the abortion industry is putting women’s lives at risk every day with their “evidence-based protocol.” We need to ensure a physician’s physical presence and put an end to telemed abortions; but it is also necessary to ensure that the physician is not endangering the woman’s life with quack medicine.

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