FDA’s French Abortion Pill Ban Ruled Illegal

Abortion rights advocates succeeded Tuesday in opening a first crack in the government’s barrier against the importation and use of the French abortion pill, as a federal judge in New York ruled that the Food and Drug Administration illegally barred a pregnant woman from importing the drug for her own use.

But Justice Department lawyers filed an immediate appeal Tuesday afternoon and a federal appellate court agreed to put the ruling on hold while it studies the issue.

The initial ruling--which came in response to the first legal challenge to the U.S. import ban on RU486--would require U.S. Customs officials to give back the pills that were confiscated from a 29-year-old pregnant woman who landed at Kennedy International Airport on July 1.

The decision also would clear the way for other American women to import the abortion pill for their own use.

Nonetheless, attorneys on both sides predicted a prolonged legal and political battle over the pill, which has been available for use under controlled conditions in France and Great Britain.

Anti-abortion activists in the United States have threatened to boycott the products of any drug firm seeking to market the abortion pill here and no companies have sought FDA approval to test or distribute it.

Since 1988, however, the FDA has allowed people to import for their “personal use” drugs that have not been officially approved.

But a year later, the FDA said that this “personal use exception” did not cover RU486. Instead, the agency told Customs agents that the drug was subject to “automatic detention” if found on travelers.

In his ruling Tuesday, U.S. District Judge Charles P. Sifton noted that this move to exclude the abortion pill came one month after anti-abortion advocates in Congress, including Rep. Robert K. Dornan (R-Garden Grove), complained to the FDA that its policy amounted to “abetting abortion.”

“The decision to ban the drug was based not from any bonafide concern for the safety of users of the drug, but on political considerations having no place in FDA decisions,” Sifton said.

The judge said the FDA acted “illegally” in preventing Leona Benten, who is seven weeks pregnant, from bringing the abortion pill into the United States. She did so under a doctor’s care, he noted, so there was no medical reason to stop her from using the drug.

“This is a symbolic first step toward American women gaining access to this drug,” said Rachael N. Pine, an attorney with the Center for Reproductive Law and Policy, which represented Benten in her effort to import the pill. Even if the ruling survives the government’s appeal, “it does not mean that all American women will be able to get this drug. It is difficult to obtain,” she said.

If taken during the first nine weeks of a pregnancy, the pill causes uterine contractions, leading to abortion. The drug is carefully controlled in France and Great Britain but it has been found to be safe if taken under a doctor’s supervision.

Women’s rights advocates say that the pill offers the promise of a painless and private way of ending an unwanted pregnancy and they say that U.S. officials should encourage wide testing here.

Anti-abortion advocates question the safety of the pill and say it could only encourage abortion as a casual and thoughtless option. The National Right to Life Committee denounced Sifton as “an activist federal judge (who) exercised raw judicial power.”

“By opening the door for more women to bring the dangerous unapproved RU486” into the United States, the decision “jeopardizes the lives and health of the women and threatens the lives of their unborn children,” said Richard D. Glasow, the NRLC’s education director.

An FDA spokesman denied that the agency’s decision to exclude the abortion pill stemmed from the Bush Administration’s opposition to abortion.

In response to complaints from AIDS and cancer patients, the FDA said that patients with “serious and life-threatening diseases” could import unapproved drugs for personal use.

“This (RU486) doesn’t cut it under that guideline,” said Gary Fendler, an FDA spokesman.