RU 486 Proponents Step Up Efforts
By Randall K. O'Bannon, Ph.D.NRL Director of Education and Research

When the U.S. Food and Drug Administration (FDA) gave preliminary marketing approval to RU 486 in September 1996, calling it "safe" and "effective," many believed release of the abortion pill was imminent. Yet legal troubles with investors, the loss of a would-be manufacturer, and subsequent difficulties in meeting the labeling and manufacturing requirements necessary for final government approval created setbacks that have, to date, kept the drug off U.S. shelves.

Several recent news sources are now reporting that RU 486 may be on the market by the end of the year. In its January/February issue, Mother Jones magazine noted that the Danco Group, the group licensed by the Population Council to market RU 486, "has, at long last, found manufacturers," though Danco declined to identify them. The Population Council is RU 486's U.S. patent holder.

A February 23, 1999, report from Reuters Health also indicated that Danco had "identified manufacturers willing to produce mifepristone [RU 486]," and quoted Danco spokesperson Heather O 'Neill as saying "we're working toward production."

Precisely what O'Neill meant by this is unclear, since she was later referenced as the source for information that the Danco Group was "now negotiating with manufacturers." O'Neill noted that the FDA "will not grant final approval until it has inspected and signed off on the company's manufacturing process and facilities," and indicated that Danco and the manufacturers " expect to have all outstanding issues cleared up soon."

In a March 23, 1999, report, the Washington Post repeated much of the same information, that Danco had found manufacturers willing to make the drug and was working with the FDA to gain final approval to market the drug in the U.S. The Post included O'Neill's statement that Danco was confident enough of its timetable to begin contacting doctors "to discuss how best to prescribe and administer the drug."

While Danco and the Population Council have been trying to get production rolling, a separate group, Abortion Rights Mobilization (ARM), has been conducting "tests" of its own version of RU486 (whether the pill is an exact copy or simply a similar formula is not clear). The Post reports that in the past year and a half, over 3,000 women have taken the ARM pill at 15 centers scattered across the country. (The Post mentions Baltimore, Seattle, Bellevue, Nebraska, and Cherry Hill, New Jersey.) Abortionists in the ARM trials are experimenting with having women take the second drug in the procedure at home, eliminating the second of three customary trips to the doctor.

Recent experience in Vermont strongly suggests chemical abortions (and their complications) will not be adequately tracked and reported.

Violating state law that requires that all abortions be reported to the state health department, Planned Parenthood of Northern New England failed to report 102 abortions performed using RU 486 in Vermont in 1994 and 1995, according to the Associated Press (12/4/97). Vermont was one of 17 locations participating in U.S. trials of the abortion drug between October 1994 and May 1995.

Vermont pro-life state representative Nancy Sheltra (R-Derby) noticed the discrepancy when reviewing state vital statistics. She argued that Planned Parenthood should have been fined, as the state statute provided. State officials disagreed, saying Planned Parenthood ultimately owned up to the mistake and provided the information, obviating the need for any sanctions. A spokeswoman for Planned Parenthood termed the failure to report the abortions to the state an "oversight" and indicated results of the trial had been reported to the FDA, the federal agency overseeing the RU 486 trials.

According to the Associated Press, Sheltra wondered whether other abortions were going unreported and asked, "Where else have they been negligent on reporting?" A state official said deviations from expected numbers would be evident, so he doubted there were abortions being hidden, the Boston Globe reported.

RU 486 to Canada and Germany?
Repeating a pattern similar to the one played out in the U.S., Health Canada, the government agency responsible for the approval of all drugs sold in Canada, has sent a letter to Exelgyn, the European manufacturer of RU 486, informing it that any application for the drug would receive a "fair hearing." The Canadian letter was sent at the request of Penny Priddy, health minister for British Columbia, who has supported the drug's approval for some time. Similar public signals were sent in late 1992 and early 1993 by representatives of the U.S. FDA and the Department of Health and Human Services.

The Health Canada letter provoked controversy because the Canadian Food and Drug Act prohibits the government from soliciting drug applications, since it might give the perception of a bias favoring the drug. Those arguing against the introduction of RU 486 into Canada believe that the government agency inappropriately tipped off its intentions by responding to Mrs. Priddy's request in a letter.

As of March 13, 1999, Exelgyn had not filed any application with Health Canada, according to the National Post.

Exelgyn has also recently made an application to market RU 486 in Germany.
On March 18, 1998, Exelgyn filed an application with the Bundesinstitut fuer Arzneimittel und Medizinprodukte, the private agency responsible for approval of all drugs and medical devices sold in Germany.

Exelgyn took the step only after a letter from the newly elected German Chancellor Gerhard Schroeder appeared in Germany's top left-wing feminist magazine EMMA. Schroeder declared he would welcome RU 486 to the market if it would give women a better choice of abortion methods.

When Edouard Sakiz, Exelgyn's head, ran Roussel Uclaf (the original developer and patent holder for RU 486), it was company policy not to market the pill in any country where there was not public support.

A spokesman for Schroeder later said the chancellor's remarks were "misinterpreted," but ministers from his coalition government presented a draft amendment March 2 seeking to overturn sections of the German drug law which could inhibit the abortion pill's introduction to the German market.

In September 1998, Schroeder's Social Democratic Party replaced the government of longtime Chancellor Helmut Kohl, who had opposed the introduction of RU 486.

Plans for the Third World
Efforts to expand use of the drug to developing countries, detailed in past issues of NRL News, continue unabated. In a " consensus statement" issued by the Population Council following a July 6-10, 1998, meeting in Bellagio, Italy, health representatives from 10 countries endorsed the use of chemical abortions "even in the most basic settings, so long as back up care is available to treat women who experience complications or method failure."

Cutting corners was obviously on the mind of those who signed the statement. Ultrasound, while considered helpful by the signatories in estimating gestational age and diagnosing ectopic pregnancy or incomplete abortions, was termed "not essential for the provision of safe medical [their term for chemical] abortion."

Neither was "direct supervision" by medical personnel thought necessary, as long as easy access to medical care is available should problems arise. While experience has shown decreasing " efficacy" and increasing side effects the later RU 486 is used in pregnancy, signatories argued that "[i]n many settings, the reduced efficacy may still be high enough, and the increased side effects acceptable enough, to justify offering this regimen to women."

Further research, the signatories suggest, could refine and simplify the protocol, making it "more accessible and affordable." Even where "optimal conditions" for the drugs' introduction are not present, the statement alleges, chemical methods "may represent a critical advance in women's health," particularly "in settings where the consequences of unwanted pregnancy are sufficiently severe."