Bush's FDA Nominee Grilled Over 'Morning After Pill'

July 7, 2008 - 8:23 PM

(CNSNews.com) - President Bush's nominee to head the Food and Drug Administration told a Senate committee Tuesday that his decision to move forward on over-the-counter sales of the "morning-after pill" was based "not on a political ideology, but on a medical ideology."

Dr. Andrew von Eschenbach currently serves as acting commissioner of the Food and Drug Administration (FDA), but the president's choice of von Eschenbach to permanently head the agency is drawing fire from cultural conservatives who oppose over the counter availability of the emergency contraceptive.

Von Eschenbach's appearance Tuesday before the panel considering his nomination -- the Senate Health, Education, Labor and Pensions Committee -- was dominated by questions over his handling of the issue involving the morning after pill, which is also known as Plan B.

The FDA on Monday announced that it would work with the pharmaceutical subsidiary Duramed to try to "resolve the remaining policy issues associated with the marketing of Plan B as an over-the-counter option" to women over the age of 18.

The morning-after pill consists of a high dose of ingredients found in birth control pills. It can be used to either prevent the release of an ovum, or prevent implantation of an embryo into the uterine lining if taken within 72 hours following unprotected intercourse.
"No one told me what I should or could do. No one told me what decision I must or must not make," von Eschenbach told the Senate Health Committee. "This was my assessment and my commitment and I hope you'll judge me on that record."

The committee will decide whether to send the nomination to the full Senate for a vote. However, Democratic Sens. Hillary Clinton of New York and Patty Murray of Washington State have indicated that they will hold up von Eschenbach's nomination until the FDA approves Plan B for over the counter sales.

"This is a slippery, dangerous slope we are on, doctor, and we are looking to you to make a decision," Clinton told von Eschenbach. She added that she was concerned that the FDA was being politicized.

"Unfortunately, this is not just about Plan B," Clinton told von Eschenbach. "Once we start politicizing the FDA there is no stopping it; and from my perspective, it is essential that we draw the line. And we're drawing the line right here."

Massachusetts Democratic Sen. Edward Kennedy was suspicious of the FDA's willingness to resolve the remaining issues related to over the counter availability of Plan B.

If the FDA's announcement "leads to a swift and clear decision, I applaud it," Kennedy said, "but we must make certain that the administration does not use it as yet another delaying tactic."

The conservative Family Research Council (FRC) on Tuesday declared its opposition to the von Eschenbach nomination and urging Wyoming Republican Sen. Mike Enzi, chairman of the Health, Education, Labor and Pensions Committee, to do the same.

"This week's news reports indicate the FDA, under Dr. von Eschenbach, is once again ignoring concern for women's health and preparing to allow adult women to buy the emergency contraceptive Plan B over-the-counter (OTC) without a prescription while also trying to continue Plan B as a prescription for women under the age of 18," the FRC stated in a letter to Enzi.

"Plan B's availability by this novel arrangement raises a host of legal issues, social and behavioral challenges, and questions of federalism. There is no precedent for the granting of dual status approval for the same drug to different age groups," the letter stated.

Rev. Carlton W. Veazey, president and CEO of the Religious Coalition for Reproductive Choice said it is a "good thing for women's health" that the FRC is opposing the nomination.

"It means Dr. von Eschenbach is trying to base his actions and decisions regarding women's health on scientific fact," Veazey told Cybercast News Service . "The Family Research Council doesn't like scientific fact that contradicts its political agenda."

He added that the FRC's "objections to this form of ordinary birth control have been repeatedly discredited and rejected by medical experts."

The FRC, however, stood by its statements and questioned the FDA's authority on the matter of the morning-after pill. "FDA does not have the enforcement authority to ensure that store clerks are checking age ID for dual status drugs. Given FDA's track record with RU-486, it is difficult to see how they will enforce a strict distribution agreement with Plan B," the FRC stated.

"Recognizing the importance of the health of women and the role the FDA plays in protecting that health, Family Research Council cannot in good conscience support the confirmation of Dr. von Eschenbach as FDA Commissioner," the statement added.

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