FDA Nominee Blocked Over “Morning-after” Pill

By
April 21, 2005

Mills College Weekly

Responding to a hold-up in a decision about emergency contraception, two Senate Democrats moved to block a full Senate vote that would have confirmed President George W. Bush’s nominee for Commissioner of the U.S. Food and Drug Administration.

Sen. Hillary Clinton (D-NY) and Sen. Patty Murray (D-WA) are holding off the confirmation of Lester Murray, currently acting commissioner of the FDA, because they say he has unnecessarily delayed a ruling that would grant over-the-counter status to the controversial emergency contraception pill.

The so-called “morning-after” pill, or EC, was passed by a safety advisory committee in January, and the FDA was expected to make a decision by the end of that month. As the pill has been scientifically approved for nonprescription sales, the senators said they believe that the delay is political. Clinton and Murray are planning to block the vote until they get an answer, one way or another.

“From everything we’re able to determine,” Murray told the New York Times, “the agency has substituted politics and ideology for science and facts.”

Pharmaceutical company Barr Laboratories first applied for over-the-counter status for their EC pill, called Plan B, in April 2003. An FDA advisory committee approved it by a 24 to 3 vote, but the administration ultimately rejected the application because there had not been enough research on the effects of the drug on women under 16.

The manufacturer re-submitted the application with an addendum that restricted over-the-counter sales to those 17 years of age and older.

Two years later, there is growing suspicion that ideology is behind the delay.

“The bottom line is that the FDA has had the Plan B application for years,” Clinton said in a statement, “and the American people simply need an answer, 'yes or no.' Science should never take a back seat to politics and ideology."

EC is dramatically different from the “abortion pill,” RU-486, which causes an already implanted embryo to detach from the lining of the uterus.

Counter-interpretations of the word “pregnancy” may be responsible, in part, for the confusion around the drug’s purpose and the stalling of the decision whether or not to make it more easily available.

Many conservative and anti- abortion groups define pregnancy as beginning at conception (when the sperm penetrates the egg), and consider any purposeful interference post-conception an abortion. But according to the medical definition, which is supported by the United States Department of Health and Human Services, pregnancy begins when a pre-embryo is implanted in the uterine lining.

The emergency contraceptive, which can be taken up to five days after intercourse, prevents the implantation of the embryo. By definition, EC falls into the space between the conflicting points-of-view.

Fighting uphill in the conservative political climate, advocates of over-the-counter EC are working to defend medical definitions in common discourse, and to maintain the distinction between science and political or religious ideology.

“Politicians don’t have the background to make medical decisions,” said Nicole Yellich, Community Outreach Manager at the San Francisco office of NARAL ProChoice America. “You have two different issues and we are always in favor of keeping them separate.”

Senior Mina Dante agreed. “In the end, science will remind politicians that we can be wrong. We may end up hurting people in the long run because politics are often fixed and refuse to accept science,” she said.

While anti-abortion advocates believe that the use of emergency contraception is itself a form of abortion, supporters of over-the-counter EC argue that it will safely reduce the number of undesired pregnancies.

“One of the ways the so-called emergency contraception works is by not allowing a life that has been conceived to implant in the woman's womb,” Wendy Wright, spokeswoman for the anti-abortion group Concerned Women of America told Salon.com.

“Implantation is simply the process by which the new life gets nutrition; so it causes the death of that new life,” she said.

But the conflict remains definitional.

“Emergency contraception meets all the safety qualifications for over-the-counter medication,” said Erin Kiernon, Communications Director at Planned Parenthood Golden Gate, “It has no effect on an existing pregnancy. Expanding access to EC is the surest way to prevent unwanted pregnancies.”

“We believe these decisions are politically and ideologically driven,” Kiernon added.

Cynthia Turner, health program director at Mills, agreed that emergency contraception should be more easily available, as long as people are educated about proper use.

Currently, Mills students can obtain a prescription over the phone by consulting with the advice nurse at Tang Medical Center, Turner said.

“The advice nurse can fax a prescription to a pharmacy near the student and it can be picked up and paid for by the student’s insurance sometimes, or can be reimbursed later by their insurance,” she said.

Murray and Clinton decided to block the vote following a meeting with Crawford last week regarding the status of the Barr application.

“They were unwilling to give us a clear timeline. The FDA is saying they are trying to cross all the t’s and dot all the i’s on this application because of fear of litigation, which is not a scientific reason to delay approval,” said Murray in a press release.

Clinton announced that she will block the vote “for as long as it takes to get a decision made.”


FDA Nominee Blocked Over “Morning-after” Pill was published on April 21, 2005 in News

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