WASHINGTON (CNS) — The head of the U.S. bishops’ Committee on Pro-Life Activities expressed “grave concern” about a drug labeled as an emergency contraceptive and the Food and Drug Administration’s process for approving it.
He said it was misleading to call it a contraceptive, as it is also known to cause abortions.
In a June 17 letter to Dr. Margaret Hamburg, FDA commissioner, Cardinal Daniel N. DiNardo of Galveston-Houston criticized the advisory panel’s hearing that day on the drug. 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.
The drug, ulipristal, is being marketed under the brand name ellaOne or ella, and would be available only by prescription. The drug is said to prevent pregnancy five days after sex — two days longer than the morning-after pill known as Plan B, which is sold over-the-counter to women 17 and older.
The FDA’s advisory panel of 11 reproductive health experts voted unanimously for ulipristal’s approval and called it safe and effective. Although the FDA is not required to follow the panel’s advice, it often does.
The drug, manufactured by a French pharmaceutical company, is currently available in 22 European countries.
In his letter, Cardinal DiNardo raised concerns that the new drug is more similar to the drug RU-486 — which can cause abortions several weeks into pregnancy — than it is to other emergency contraceptives, which are believed to have an effect on a fertilized egg after implantation in the uterus.
“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,” said Cardinal DiNardo. “They would be ill-served by a misleading campaign to present ulipristal simply as a ‘contraceptive.'”
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.
In a June 2 letter to the FDA, Donna Harrison, president of the American Association of Pro-Life Obstetricians and Gynecologists, described ulipristal as “an abortifacient of the same type as mifepristone” and said its “approval as an emergency contraceptive raises serious health and ethical issues.”
The letter said the new drug had the potential to “destroy established pregnancies as well as prevent implantation.”
Plan B, approved by the FDA in 1999, prevents pregnancies with its 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.
Cardinal DiNardo noted that for many years, “Congress has acted to ensure that the federal government does not fund abortion and does not endanger or destroy the early human embryo even in the name of important medical research.”
He also said the current administration has similarly “voiced support for federal laws to ensure that no one is involved in abortion without his or her knowledge or consent.”
“Plans for approving a known abortion-causing drug as a ‘contraceptive’ for American women is not consistent with the stated policy of the administration on these matters,” he added.
The FDA is scheduled to make a decision on the drug by late July.
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