Mifepristone near approval by FDA

By Lindsey Alpert

Daily Staff Reporter

The abortion drug mifepristone is crawling closer to approval by the Food and Drug Administration.

The FDA sent an approvable letter to the Population Council on Friday. An approvable letter informs the sponsor of issues surrounding the drug that need to be solved before it is approved for marketing.

Mifepristone has been used in European countries for more than a decade.

The Population Council, an international nonprofit institution that conducts biomedical, social science and public health research, filed a new drug application with the FDA on March 18, 1996.

An FDA advisory committee found that the drug was safe in clinical trials and advised that it be approved in July of that year. An approvable letter was sent out in September 1996, to which the Population Council responded and corrected the issues.

In a statement released by Danco Laboratories LCC, a New York-based women's health pharmaceutical company which was given an exclusive license to the drug by the Population Council, the organization expressed pleasure with the letter.

Danco views it as "a major step forward in the complex drug approval process necessary to make the early option pill, mifepristone, available in the United States."

The company also said in the statement that it is working on providing all the information that the FDA requested.

If the drug is approved, it will be available for use by abortion clinics across the country.

But it will not be offered at the University Health Services.

"We have, thus far, made a decision to not do abortions at the health service or use abortion induction programs," interim UHS Director Robert Winfield said.

"We feel that we do not have the ability to give 24-hour coverage in case of a complication with the abortion."

Winfield also said he did not feel the clinic has the sufficient equipment or training necessary. "It's based on wanting to do an excellent job in whatever we do," he said.

But UHS does offer the option of counseling for pregnant women.

According to the Population Council Website, mifepristone is an antiprogestin that interrupts pregnancy in its early stages by blocking the action of progesterone, a natural hormone that prepares the lining of the uterus for a fertilized egg and then maintains the pregnancy.

Mifepristone is used in combination with the drug misoprostol to ensure a greater chance of a terminated pregnancy.

"I want to make a distinction between the morning-after pill and the abortion pill," Winfield said. "UHS offers preven and Plan B for those who had contraception failure or didn't use contraception."

Morning-after pills must be taken within 72 hours after unprotected sexual activity, but mifepristone is effective for about 10 weeks after conception occurs.

The Website also said about five out of every 100 women who undergo medical abortion will need a surgical abortion because the pill was ineffective.

But the site also said this type of abortion is a less invasive process and has the potential for greater privacy.

There are also fewer side effects with medical abortion, which can include nausea, vomiting, cramping and urinal bleeding.

"I think it's really important to find ways to give women back the power to take control over their reproductive health," said Students for Choice co-President Jennifer Anderson, an Education junior. "As long as its considered safe, I think it's a great step."

Many critics of the pill say it makes abortion easier and worry that the pill will be used as a form of birth control.

"If the abortion pill does what it says it does, obviously being pro-life, I'm against it," said Students for Life President Melissa Osborn, an LSA senior. "It becomes, so to speak, more convenient."

"Part of our mission is helping women in those situations to get the help they need to keep their babies," Osborn said.