Abortion Pill Talks Are Aimed at Opening Up U.S. Market

Six years after the controversial RU-486 abortion pill was legalized in France, a New York-based population research group and Roussel Uclaf, the drug’s manufacturer, are engaged in negotiations to allow testing and distribution of the drug in the United States.

The Population Council, a nonprofit organization devoted to improving access to birth control, is “engaged in active, high-level, negotiations with Roussel on a daily basis,’ said Sandra Waldman, a spokeswoman for the organization.

Waldman expressed optimism that the two sides would eventually reach agreement, but there is no timetable set for progress in the talks.

But Marcy Wilder, legal director for the National Abortion and Reproductive Rights Action League, said Roussel “is dragging its feet” on getting the drug into the United States because of the intense battle over the abortion issue in this country.

American women were given a legal method of obtaining the drug last month when Britain--one of four countries where RU-486 is legal--agreed to allow foreigners to obtain the drug there for a $500 fee.

BACKGROUND: RU-486, when taken with a second hormone, induces a “chemical abortion.” Testing has indicated that the drug is 96% effective in ending a pregnancy.

The drug has been the subject of emotional debate since it was legalized in France in 1988. After a boycott threat from anti-abortion groups, Roussel stopped distributing the drug a month after its approval. Two days later, however, the French health minister ordered the company to resume distribution, saying that “RU-486 became the property of women, not just the drug company.”

Roussel complied, but the company did not introduce the drug into the United States, where a similar boycott was threatened and then-President George Bush’s Administration strongly opposed abortion.

With the election of President Clinton, who is a proponent of abortion rights, the company switched its position last April and agreed to move toward U.S. distribution. Roussel, however, is only selling its technology and will not join in the manufacture or distribution of the drug here.

The Clinton Administration has given its permission for the Population Council to negotiate with Roussel. Limited clinical trials have already been conducted by the National Institutes of Health and the USC Medical Center.

In addition to France and Britain, Sweden and China also have legalized the drug.

NEXT STEP: If the Population Council and Roussel reach a distribution agreement, the council will submit an application to the Food and Drug Administration for approval of the drug.

FDA officials would not speculate on how long its review might take, but those familiar with the process estimate that it could last one to three years. The length of the review process generally depends on the medical priority of the drug, the amount of medical documentation available and information gathered during U.S. clinical trials.

A potentially lifesaving, high-priority medication--such as a new AIDS drug--can win approval in as little as 11 months, while reviews of lower-priority drugs can take several years, said FDA spokesman Larry Bachorik.

While RU-486 is the subject of volumes of documentation in medical journals, the FDA still would need to review U.S. clinical tests carefully, Bachorik said.

The FDA must “make sure the drug, even though it’s had extensive use in Europe, works properly and effectively in this country” and that U.S. doctors are properly trained in its use, he said.

If RU-486 is approved, its release could significantly alter the strategies employed by both sides in the abortion debate.

With only about 10% of medical schools in the United States still teaching abortion procedures, and with the number of abortion clinics dwindling, a drug that is relatively simple to administer would force anti-abortion groups to rethink many tactics they have used in efforts to curtail the estimated 1.5 million abortions performed in this country annually.