Path Cleared for Abortion Pill Use : Medicine: French maker of RU-486 gives patent rights to a nonprofit group. Testing, FDA approval are required to meet goal of licensing drug in U.S. by 1996.

In a move designed to speed U.S. development of the RU-486 abortion pill, the French manufacturer donated its patent rights to a nonprofit group Monday, with a view toward clinical trials and licensing of the drug in the United States by 1996.

Roussel-Uclaf gave its patent rights to the Population Council, an international nonprofit organization engaged in scientific research. The council will conduct the tests and select an American company to produce the abortion pill.

The unusual arrangement, encouraged by the Clinton Administration, overcomes a major obstacle to widespread use of RU-486 in this country. The manufacturer, along with its German parent company, Hoechst AG, had refused to market the drug here largely out of fear that anti-abortion advocates would boycott its other products.

The drug must be declared safe and effective by the Food and Drug Administration before it can be made available in the United States.

Monday’s development marked an extraordinary turnaround since the George Bush Administration banned importation of RU-486 in 1992. As a sign of the depth of the controversy, Roussel-Uclaf still declined to market the drug here even after President Clinton overturned the ban in 1992.

The Population Council, which was established in 1952, has its headquarters in New York City and offices in 16 other nations. It has developed six major contraceptive methods now in worldwide use and favors access to safe, effective abortions for women, especially in developing nations. Its chairman is McGeorge Bundy, White House national security adviser during the Democratic administrations of Presidents John F. Kennedy and Lyndon B. Johnson.

“We believe this action is an important step toward providing the women of America with non-surgical alternatives to pregnancy termination,” said Donna Shalala, secretary of Health and Human Services.

Rep. Ron Wyden (D-Ore.), who has tried to make the drug available in this country, said clinical trials involving 2,000 women at 12 U.S. sites would begin this fall, followed by an application to the FDA for approval. The drug also is being tested for treatment of breast cancer and other diseases.

In addition to its use as an abortion pill, RU-486 may have applications as a “morning-after pill” to prevent pregnancy. Tests to determine its safety and usefulness in that respect are under way at UC San Francisco.

Wyden said RU-486--formally known as mifepristone--has been used for abortions in the first seven weeks of pregnancy by 150,000 women in France, Britain and Sweden.

“I am very hopeful that American women can get this drug early in 1996,” he said at a news conference. “The days of stalling and foot-dragging on this issue are over.”

Opponents of abortion condemned the agreement and questioned whether RU-486 is a safer alternative to surgical abortion. Rep. Christopher H. Smith (R-N.J.), a leader of anti-abortion forces in Congress, said women adversely affected by the drug would not be able to recover damages from a nonprofit agency.

“That should be a red flag to any woman who thinks this newest form of baby poisoning is safe,” Smith said.

FDA Commissioner David A. Kessler said his agency has encouraged the filing of a new drug application for RU-486.

“If there is a safe and effective medical alternative to any surgical procedure, American women should have access to that drug regimen,” Kessler said Monday at a hearing on RU-486 conducted by the House Small Business subcommittee on regulation, business opportunities and technology.

But Kessler added words of caution: “Women should not think that pregnancy termination using a medical regimen will be simple. It will not be.”

RU-486 works by blocking the development of progesterone, a hormone essential for maintaining pregnancy.

In Europe, the drug typically is dispensed in a doctor’s office or clinic. Two days later, a woman receives a dose of prostaglandin, a hormone that causes contractions that expel the embryo. The woman then must be monitored for complications, including excessive bleeding. She also must have a follow-up visit in a week to ensure that the abortion has been successful.

“We anticipate that any use of RU-486 in the United States would have to follow the same type of strict distribution and use conditions,” Kessler said.

Proponents said the drug would be less invasive than surgical abortion, reducing the risk of infections and damage to the cervix or uterus.

The first clinical trials on RU-486 were conducted in 1983 at the University of Southern California. It was then made available in France in 1988.

Clinton overturned the ban on RU-486 two days after taking office, directing Shalala to devise a strategy for promoting the testing and licensing of the drug here.

Negotiations between the French manufacturer and the Population Council dragged on for more than a year until Shalala set a May 15 deadline, producing the agreement announced Monday.

Margaret Catley-Carlson, president of the Population Council, said in a statement that her organization is “exhilarated” by the outcome of the talks.

“We are confident we will be able to arrange for manufacture and distribution in the United States,” she said. “We plan to move quickly to arrange for financing, insurance, manufacture and distribution so that all will be in place by the time we receive FDA approval.”

Abortion rights supporters hailed the agreement as a long-delayed triumph for medical science over politics. Abortion opponents, however, said the drug may be too risky.

“This milestone victory will significantly increase abortion access and fundamentally reshape abortion debate by finally providing American women with the only known form of early abortion,” said Eleanor Smeal, president of the Feminist Majority Foundation.

However, Judie Brown, president of American Life League, Inc., declared: “This chemical effectively kills children who live in the womb and is not safe for the mother, according to many scientific reports. . . . The Clinton Administration is so dedicated to killing human beings who live in the womb that they are now prepared to jeopardize the lives of those babies’ mothers as well.”