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Heads Should Roll at FDA

Wednesday, June 9, 2004

The FDA's rejection of the emergency contraception known as Plan B was a display of inappropriate political tampering with a science-based decision-making process. That is why one congresswoman is calling for FDA resignations.

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The FDA's rejection of the emergency contraception known as Plan B was a display of inappropriate political tampering with a science-based decision-making process. That is why one congresswoman is calling for FDA resignations.
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Louise Slaughter

(WOMENSENEWS)--In yet another example of the Bush administration playing politics with health care, the U.S Food and Drug Administration last month rejected an application by Barr Laboratories to allow its emergency contraceptive, Plan B, to be sold over the counter without a prescription.

Allowing women greater access to emergencycontraception could cut the unintended pregnancyrate in half and drastically reduce the numberof abortions performed in this nation. These sound like goals that everyone can agree on, Democrat and Republican alike. Yet the FDA caved to right-wing ideologues and denied women over the counter access to emergency contraception.

The FDA's own scientific advisory panels and staff had overwhelmingly recommended that this drug be made available to American women over-the-counter. They had determined that the scientific facts irrefutably show that this drug is a safe, effective way for women to prevent unintended pregnancy. But the FDA went ahead and blocked over the counter sales, claiming that there was not enough information about its safety for young women.


Inappropriate Politics

There have been serious allegations that what should have been a science-based decision was influenced by inappropriate political considerations. Two of the members of one of the advisory committees who considered this application, Dr. Michael F. Greene and Dr. Alastair Wood, published an editorial in the New England Journal of Medicine in April in response to the FDA's announcement that it was delaying its decision on whether to make Plan B available over-the-counter. In that commentary, these distinguished scientists said the FDA's move "suggests that the FDA's decision-making process is being influenced by political considerations."

In that same editorial, the authors went on to say that the "data overwhelmingly demonstrate that emergency contraception is safe and effective when available without a prescription."

They also shot down the arguments that better access to the medication will boost promiscuity or other risky behavior, saying that "the evidence shows that the availability of emergency contraception does not result in a change in the usual behavior or contraceptive practices of the women who are its potential users. A treatment for any other condition, from hangnail to headache to heart disease, with a similar record of safety and efficacy would be approved quickly."

The two doctors also said that allowing political interference with what should be a science-based decision could undermine public confidence in the drug approval process.

This concern was echoed by Vivian M. Dickerson, president of the American College of Obstetricians and Gynecologists, who said the agency's action "is a tragedy for American women and a dark stain on the reputation of an evidence-based agency like the FDA."


Irregular Decision

Even FDA officials admit that this decision was irregular. According to The New York Times, Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research and the person who signed the "not-approvable" letter, said, "I am not trying to convey this decision as being common or usual."

Former FDA officials "could not remember another instance in which Dr. Galson
. . . or any of his predecessors had overruled both an advisory committee and staff recommendations."

As a scientist myself, I find it extremely troubling that the FDA so readily ignored the scientific facts about Plan B. The integrity of the FDA drug approval system, and of public confidence in the safety and efficacy of the drugs FDA approves, depends on these decisions being free from political influence. American women--indeed, all Americans--trust the FDA to make the best decisions possible with respect to their health.

That is why, as Democratic co-chair of the Congressional Pro-Choice Caucus and the Congressional Caucus for Women's Issues, I have called on President Bush to request the resignations of FDA Acting Commissioner Lester Crawford and Dr. Steve Galson. They must be held accountable for this appalling decision that so clearly goes against the scientific data. Along with Rep. Henry Waxman, I also initiated a letter signed by 27 of our colleagues requesting that the General Accounting Office conduct an investigation into the way this decision was made.

Americans must be able to trust that the federal agency responsible for giving them access to miraculous drugs will leave politics out of decisions that can so profoundly affect their health. We cannot allow future FDA decisions to be jeopardized by partisanship.

Louise M. Slaughter, a microbiologist with a master's degree in Public Health, serves as U.S. Representative from the 28th Congressional District of New York.

For more information:

HealthDayNews--
"FDA Adds New Hurdle to 'Morning-After' Pill":
http://yalenewhavenhealth.org/healthnews/healthday/040507HD518837.htm