Concern over FDA Plan to Approve Ulipristal Abortion Drug

Topic: Female Health
Author: U.S. Conference of Catholic Bishops Secretariat for Pro-Life Activities
Published: 2010/06/18 - Updated: 2023/02/10
Contents: Summary - Definition - Introduction - Main - Related

Synopsis: Pro-Life chair voices grave concern over FDA plan to approve abortion drug for emergency contraception. Plans for approving a known abortion-causing drug as a 'contraceptive' for American women are not consistent with the stated policy of the Administration on these matters. The Cardinal raised concerns that Ulipristal is more similar in effect to the drug RU-486, which can cause abortions several weeks into pregnancy, than other emergency contraceptives, which are believed to have no post-implantation effects.

Introduction

The chairman of the U.S. bishops' Committee on Pro-Life Activities voiced "grave concern" to the U.S. Food and Drug Administration (FDA) over its move toward approving a new drug that may induce early abortions as an "emergency contraceptive." In a June 17 letter to Dr. Margaret Hamburg, Commissioner of the FDA, Cardinal Daniel DiNardo of Galveston-Houston criticized the FDA's move to hold an advisory committee meeting on the drug Ulipristal "without broad public input or a full record on the drug's safety for women or their unborn children."

Main Digest

The Cardinal raised concerns that Ulipristal is more similar in effect to the drug RU-486, which can cause abortions several weeks into pregnancy, than other emergency contraceptives, which are believed to have no post-implantation effects.

"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.' FDA approval for that purpose would likely make the drug available for 'off-label' use simply as an abortion drug - including its use by unscrupulous men with the intent of causing an early abortion without a woman's knowledge or consent. Such abuses have already occurred in the case of RU-486, despite its warning labels and limited distribution."

Cardinal DiNardo cited the support of this and previous Administrations for federal laws ensuring no one is involved in abortion without their knowledge or consent, as well as the Obama Administration's rationale for supporting broad access to contraceptives as a means of reducing abortions.

"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," the Cardinal wrote.

Full Text of the Letter

Dear Dr. Hamburg:

I am writing because of grave concern over the FDA's current process for approving the drug Ulipristal (with the proposed trade name of Ella) for use as an "emergency contraceptive." The decision to hold an advisory committee hearing on the drug today without broad public input or a full record of the drug's safety for women or their unborn children does not demonstrate an understanding of the new medical and moral issues it presents.

Concerns have been raised over other drugs considered for "emergency contraception," such as the "Plan B" regimen, because they might act not only to prevent ovulation but also to prevent implantation of the developing embryo in their mother's womb. However, such drugs were thought to have no post-implantation effects. Ulipristal is a close analog to the abortion drug RU-486, with the same biological effect - it can disrupt an established pregnancy weeks after conception.

This drug is contraindicated for women who are or may be pregnant. Yet its proposed use here is targeted precisely at women who may already have conceived, as it would be administered within five days after "unprotected" sex or contraceptive failure. No existing pregnancy test can exclude the possibility of a new life being conceived in this time frame. Indeed, advocates praise this drug as an advance precisely because it seems to retain its full efficacy five days after intercourse - after the opportunity to prevent fertilization has passed.

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. They would be ill-served by a misleading campaign to present Ulipristal simply as a "contraceptive." FDA approval for that purpose would likely make the drug available for "off-label" use simply as an abortion drug - including its use by unscrupulous men with the intent of causing an early abortion without a woman's knowledge or consent. Such abuses have already occurred in the case of RU-486, despite its warning labels and limited distribution.

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. Like many before, this Administration has voiced support for federal laws to ensure that no one is involved in abortion without their knowledge or consent. And the Administration's support for broad access to contraception has been defended as serving the goal of reducing abortions. Plans for approving a known abortion-causing drug as a "contraceptive" for American women are not consistent with the stated policy of the Administration on these matters.

Please know that I appreciate any attention the FDA can give to these serious concerns, and I will follow the Administration's further discussion and actions on this issue with great interest.

Sincerely,

Cardinal Daniel N. DiNardo

Chairman, Committee on Pro-Life Activities

United States Conference of Catholic Bishops

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This quality-reviewed publication was selected for publishing by the editors of Disabled World due to its significant relevance to the disability community. Originally authored by U.S. Conference of Catholic Bishops Secretariat for Pro-Life Activities, and published on 2010/06/18 (Edit Update: 2023/02/10), the content may have been edited for style, clarity, or brevity. For further details or clarifications, U.S. Conference of Catholic Bishops Secretariat for Pro-Life Activities can be contacted at . NOTE: Disabled World does not provide any warranties or endorsements related to this article.

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Cite This Page (APA): U.S. Conference of Catholic Bishops Secretariat for Pro-Life Activities. (2010, June 18 - Last revised: 2023, February 10). Concern over FDA Plan to Approve Ulipristal Abortion Drug. Disabled World. Retrieved September 17, 2024 from www.disabled-world.com/health/female/abortion-drug.php

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