Making America Safe for RU-486: The FDA Fudged its Own Rules.

By Melissa Seckora

Yesterday, Sen. Tim Hutchinson (R., Ariz.) and Rep. David Vitter (R., La.) introduced the "RU-486 Patient Health and Safety Act" -- legislation meant to codify and strengthen the Food and Drug Administration's patient protections for women who take the abortion-inducing drug, RU-486. But wait: Isn't RU-486 supposed to be about giving women more "choices"? Why do women need to be "protected" from it?

"The legislation is about protecting women's health," said Rep. Vitter. "Last fall, the Clinton-Gore FDA caved in to political pressure from the abortion lobby and hurriedly approved the abortion drug without crucial health protections for those who use it." Under the proposed law, prescribing physicians must, among other things, be "qualified to handle complications of an incomplete abortion, be legally empowered to perform an abortion and trained to do so, and be properly trained in the administration of this drug."

On September 28, 2000, the FDA approved mifepristone, or RU-486, under an accelerated drug-approval process intended to provide new, safe and effective treatments for serious or life-threatening illnesses such as HIV/AIDS and cancer. But it's hard for even the most adamantine pro-abortion activists to argue that RU-486 -- a drug that is neither particularly safe nor effective -- should fall under the fast-track rule.

Mifepristone was approved for marketing "under 21 CFR 314 Subpart H" in a memo from an unnamed FDA official to Sandra P. Arnold, the Population Council's vice president of corporate affairs, on September 28th. Subpart H, or "Accelerated Approval of New Drugs for Serious or Life Threatening Illnesses," was adopted by the FDA in 1992 to "accelerate approval of certain drugsfor serious or life-threatening illnesses, with provisions for any necessary continued study of the drugs' clinical benefits after approval or with restrictions on use, if necessary."

According to the FDA, qualification for accelerated approval depends on whether a drug is safe and effective "in treating serious or life-threatening illnesses," and whether it will "provide meaningful therapeutic benefits to patients over existing treatments (e.g., ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy)."

In its memo to the Population Council, the FDA stated that mifepristone should enjoy the benefit of this provision because "the termination of an unwanted pregnancy is a serious condition within the scope of Subpart H," adding that "[t]he meaningful therapeutic benefit over existing surgical abortion is the avoidance of surgical procedure."

Until RU-486 came along, only 30 drugs had ever been approved under Subpart H: Exactly half of these were for the treatment of HIV/AIDS. The rest were for other debilitating diseases, such as cancer, tuberculosis, and leprosy. This makes sense, given that the FDA's definition of a "serious condition" is one "associated with morbidity that has substantial impact on day-to-day functioning." But surely a healthy pregnancy does not fall under the rubric of disease or chronic illness? Not exactly.

Curiously, the FDA defined "[the] meaningful therapeutic benefit" of RU-486 as "the avoidance of a surgical procedure." In so doing, the FDA contradicted its very own medical findings. In a November 22, 1999, medical review of RU-486, the FDA compared mifepristone-induced abortions to surgical abortions in three countries -- China, Cuba, and India -- and found that mifepristone-induced abortion caused "more adverse events, particularly bleeding, than did surgical abortion."

Still other harrowing side effects, including cramping, nausea, and vomiting, were far more prevalent among the women taking RU-486 than among women undergoing regular abortions. In 1999, a smaller study comparing the experiences of American women reported similar findings.

Nevertheless, the FDA trumpets the alleged therapeutic benefits of RU-486 over existing abortion methods. And even though its own internal studies show that taking mifepristone may lead to potentially lethal side effects, the FDA stands by its decision to fast-track the drug to market. An FDA spokesman told NRO, "As with all drugs the FDA approves, in the case of mifepristone, the FDA fully met its own standards."

If that is the case, then someone may wish to reexamine those standards. Consider the fact that Searle, the manufacturer of misoprostol, the drug that must be taken two days after the ingestion of mifepristone in order to induce an abortion, objected strongly to the use of its drug in combination with mifepristone. According to the company, misoprostol "is not approved for the induction of labor or abortion." Using it in conjunction with RU-486 therefore amounts to what doctors call an "off-label" (i.e., unapproved) use -- much like using beta-blockers to cure a headache.

Among the adverse events reported following the off-label use of misoprostol in pregnant women include maternal or fetal death, vaginal bleeding, and pelvic pain. Any one of these seems like an awfully high price to pay just to procure a more expedient abortion.

Source: National Review; February 7, 2001. Provided by The Pro-Life Infonet, a daily compilation of pro-life news and information. To subscribe, send the message "subscribe" to: infonet- Infonet is sponsored by Women and Children First ( For more pro-life info visit and for questions or additional information email

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