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FDA Official Resigns Over Plan B

Thursday, September 1, 2005

Critics are calling the FDA's decision to hold a public comment period on easing access to emergency contraception a stalling tactic. Yesterday the director of the FDA's women's health office resigned in protest.

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Critics are calling the FDA's decision to hold a public comment period on easing access to emergency contraception a stalling tactic. Yesterday the director of the FDA's women's health office resigned in protest.
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Annie Tummino

WASHINGTON (WOMENSENEWS)--Women's rights activists are giving the Food and Drug Administration exactly what it asked for last Friday: a heavy dose of public comment.

"Bad move," they are saying about the FDA's decision to open a 60-day public comment period over whether to approve a drug maker's latest application to make emergency contraception, known as Plan B, more easily available to women by allowing it to be sold over the counter instead of being dispensed only by prescription.

The activists call the move another example of FDA foot-dragging on the controversial application, which has been awaiting approval for more than two years.

Susan F. Wood, director of the FDA's Office of Women's Health, joined the detractors Wednesday by announcing her decision to resign over the incident.

"The recent decision announced by the commissioner about emergency contraception, which continues to limit women's access to a product that would reduce unintended pregnancies and reduce abortions, is contrary to my core commitment to improving and advancing women's health," Wood wrote in a public letter.

On the other side of the issue, Pia de Solenni, director of life and women's issues at the Family Research Council, a religious organization in Washington, D.C., applauded the FDA's move. "We would definitely like to see this drug restricted," de Solenni said "As long as we can't get that, we're happy that at least the decision is being postponed."


Public Comment Now Required

In his Aug. 26 statement, FDA Commissioner Lester M. Crawford said that due to Barr's unusual request to ease access to the drug for some women--those 16 and over--but to keep it prescription-only for younger women, the application required "an open process to solicit public comment."

A concentrated dose of progestin birth control pills, Plan B can prevent ovulation or fertilization if taken soon after intercourse. It might also prevent a fertilized egg from attaching to the uterine wall, which some anti-choice religious leaders equate with abortion. Abortion rights advocates disagree, saying pregnancy occurs after implantation.

Plan B differs from RU-486, a pill that terminates pregnancy.

Emergency contraceptives are available without prescription in more than 30 countries. In the United States, however, Plan B is primarily available only with a physician's prescription and wider marketing has been delayed by debate over whether it should be made available to younger women.

In his letter, Crawford focused heavily on the problems of making Plan B more easily accessible to one group of women and not all.

"Can age be used as a criterion on which we decide whether a drug should be prescription or over-the-counter, as has been proposed in this case?" Crawford said in the statement. "Can the prescription and over-the-counter version of the same drug be marketed in a single package?"

Activists, however, brushed off these concerns as yet another delaying tactic by a regulator who they say has taken a political approach to a scientific issue.

The delay is "a sexist insult to women," said Annie Tummino, vice-chair of the New York-based Women's Liberation Birth Control Project and lead plaintiff in a lawsuit filed in January at the U.S. District Court for the Eastern District of New York in Brooklyn.

The suit charges the FDA with holding the morning-after-pill to a higher standard than other drugs.

Tummino is a member of the Morning-After Pill Conspiracy Project, a coalition of organizations--including The Women's Liberation Birth Control Project, Redstockings Allies and Veterans, and the Gainesville Women's Liberation--that are pushing for greater Plan B access.

In a press conference on Tuesday, Tummino and others told positive stories about their personal experiences with the drug and, in an act of civil disobedience, illegally handed out samples of the drug.

Elsewhere that day, some two dozen activists stood in the shadow of the Department of Health and Human Services on Independence Avenue Tuesday to protest the agency's announcement.

"Not the church, not the state, women must decide our fate!" they chanted.


Removing Barriers to Access

Proponents say Plan B is a safe and effective form of post-coital birth control. Over-the-counter status, they say, would remove logistical, time and cost barriers to the drug and argue that it could dramatically reduce the number of unintended pregnancies and abortions.

In 2004 the FDA, under pressure from Plan B opponents who said there was not enough safety data about the drug's effects on younger women, overruled a recommendation made by its own advisory panel and rejected Barr Laboratories' application for approval to sell the drug without a prescription.

The company resubmitted its application later that year, asking instead for approval to make the drug available without a prescription only to those who can prove they are 16 and over.

The FDA did not reach a final decision over Barr's application by a pre-set deadline, prompting two Democratic senators--Patty Murray of Washington state and Hillary Clinton of New York--to place a hold on Crawford's then pending nomination to head the FDA.

They only agreed to lift it after securing a promise by Health and Human Services Secretary Michael Leavitt that a final decision would be made by
Sept. 1.


Young Women's Health at Issue

Critics like de Solenni say the drug threatens the health of young women and cite the FDA's stated concern that the drug's manufacturers have not provided adequate data on the health effects of the drug on young women under the age of 17.

In addition to questioning whether young women can properly follow the instructions for taking Plan B, critics also echo concerns that Crawford raised Aug. 26 about the logistical challenges of selling a drug over the counter for a certain age group (those 16 and over) but not another.

"If FDA were to attempt to limit the sale of an over-the-counter product to a particular subpopulation, would FDA be able to enforce such a limitation as matter of law and could it do so as practical matter and then how?" Crawford asked in his statement.

Proponents say the real dispute is over women's reproductive rights.

Merchants, they say, already sell products such as cigarettes and alcohol to a restricted age group. And even if Plan B does fall into the hands of a young teen, they say it is still medically safe.

"The worst thing that can happen is they get pregnant anyway," said Kim Gandy, president of the National Organization for Women in Washington, D.C.

The real problem, she said, is that the administration is "carrying the water for the Right to Life crowd," which opposes the pill because they view it as tantamount to abortion.

Dr. Scott Spear, chair of the national medical committee of The Planned Parenthood Federation of America, Inc., a reproductive health and rights advocacy group, agreed.

"This is not based on science, this is based on politics," he said. "The safety is
. . . very high for women of all ages once they are at reproductive age."

A spokesperson for the FDA declined to respond and the White House did not return calls for comment.

Allison Stevens is Washington Bureau Chief at Women's eNews.

For more information:

As It Eyes Cities, Wal-Mart Has No Plan B:
http://womensenews.org/article.cfm/dyn/aid/2350/

Plan B Access Fight May Stall FDA Nomination:
http://womensenews.org/article.cfm/dyn/aid/2254/