FDA approves drug its opponents say is known to cause abortion

WASHINGTON – The Food and Drug Administration’s decision to approve a drug labeled as an emergency contraceptive is a “dangerous step toward erasing any meaningful distinction between contraception and abortion,” said the U.S. bishops’ pro-life spokeswoman.

Deirdre A. McQuade, assistant director for policy and communications in the U.S. bishops’ Secretariat for Pro-Life Activities, made the comment in reaction to an Aug. 13 announcement by the FDA that it had approved the drug ulipristal, which is being marketed under the brand name ellaOne or ella.

Available only by prescription, the drug is said to prevent pregnancy five days after sex – two days later than the morning-after pill known as Plan B, which is sold over-the-counter to women 17 and older.

The drug, manufactured by a French pharmaceutical company, is currently available in 22 European countries.

Supporters of family planning applauded FDA approval of ellaOne, saying it was an option needed by women to prevent unwanted pregnancies, but McQuade told Catholic News Service Aug. 16 that the FDA “has done a great disservice to both women and their unborn children once conceived.”

She called it “a dangerous drug” that is “being marketed as so-called emergency contraception,” and said that because it can be used five days after sex, “it interferes with implantation or disrupts implantation after it has occurred.”

“So no matter how you define it – abortion – this is an abortifacient drug,” she said. “Even (for) those who say abortion is only an interruption of implantation, this is abortion.”

She added that women in crisis don’t need to resort to ellaOne, adding that “there are lots of resources for pregnant women in need of assistance.”

McQuade’s remarks echoed what Cardinal Daniel N. DiNardo of Galveston-Houston, chairman of the U.S. bishops’ Committee on Pro-Life Activities, said in a June letter to Dr. Margaret Hamburg, FDA commissioner.

“Millions of American women, even those willing to use a contraceptive to prevent fertilization in various circumstances, would personally never choose to have an abortion,” Cardinal DiNardo told Hamburg. “They would be ill-served by a misleading campaign to present ulipristal simply as a ‘contraceptive.’“

Cardinal DiNardo’s letter was sent the day an advisory panel of the FDA held a hearing on ellaOne. He also was critical of the FDA’s approval process.

He said the hearing – held without broad public input or a full record on the drug’s safety “for women or their unborn children” – demonstrated a failure to understand the “new medical and moral issues” the drug presents.

McQuade called ellaOne a “mini-dose” of the abortion drug RU-486, “designed to start the newly conceived, newly implanted child from having any nutrients.”

RU-486, known generically as mifepristone, was approved by the FDA 10 years ago. It induces an abortion in the first seven weeks of pregnancy when used in conjunction with another drug, a prostaglandin. The drug prevents the fertilized egg from clinging to the uterine wall, and the prostaglandin is used 48 hours later to set off contractions that expel the embryo.

Plan B, approved by the FDA in 1999, prevents pregnancies with high doses of a hormone that mimics progesterone. Although the drug works primarily by stopping ovaries from producing eggs, it can also prevent a fertilized egg from implanting in the womb.

McQuade expressed concern that “women who would never, ever seek an abortion and may be opposed to abortion might resort” to asking their doctors for ellaOne.

She said the bishops’ pro-life secretariat also was concerned about “off-label use” of the drug, meaning somebody gets it by prescription and then passes it on to someone else.

McQuade said her office will help raise awareness about the drug so people know “what it is and how it works” as well as inform women who may be facing crisis pregnancies about what alternatives exist to assist them.

She added that the bishops also would fight any efforts to make ellaOne available without prescription.

Catholic Review

Catholic Review

The Catholic Review is the official publication of the Archdiocese of Baltimore.