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June 16, 2019  
UTERINE NEWS: Feature Story

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  • Morning After Pill Under Review by FDA

    Morning After Pill Under Review by FDA

    January 31, 2005

    By: Diana Barnes-Brown for Uterus1

    Barr Pharmaceuticals, makers of the so-called “morning after pill” known as Plan B, has filed a request with the FDA, asking that the emergency contraception pill be approved for over-the-counter sale.

    Barr’s request last year to make the drug available for OTC purchase was turned down by the FDA, sparking criticism from women’s health advocates, who argued that the decision was made on the basis of conservative political affiliation, and not on the basis of the product’s safety. The FDA responded to these allegations by saying that it lacked information on the safety of the drug for patients younger than 16.

    The refilling of the request aims to address these concerns by making the cut-off age 16, while still arguing for OTC availability for those who meet the age minimum. The drug would remain available on a prescription basis for those under 16.

    According to some researchers, Plan B can reduce the chance of pregnancy by as much as 89 percent if taken within 72 hours of unprotected sex. The drug, administered via two tablets taken 12 hours apart, contains a high dose of progestin, a hormone used in birth control pills.

    Opponents of making Plan B available on an over-the-counter basis argue that availability of after-the-fact birth control will increase the likelihood that women will have unprotected sex and engage in other promiscuous or sexually risky behaviors.

    But a recent, San Francisco based study of more than 2,000 women demonstrated that there was no link between promiscuity and in-home or OTC access to emergency contraception, and these findings may be instrumental in encouraging approval from the FDA. “Women in the advance provision group … were almost twice as likely to use [emergency contraception],” than those who were not, noted author Tina R. Raine and colleagues of the University of San Francisco of their findings, which appear in the Jan. 5 issue of the Journal of the American Medical Association.

    Even so, the study did not show a difference between pregnancy rates in women who had access to Plan B and those who did not, deflating supporters’ arguments that having the drug on hand will prevent unwanted pregnancies.

    Another layer of complexity was added to the issue when the FDA’s acting director Steven Galson continued to defend the agency’s decision last year, in spite of an overwhelming 23 to 4 vote in favor of OTC sales by the FDA advisory panel. This contradiction has fueled concern that Galson is acting based on prompting by the Bush administration and other conservative politicians in Washington, rather than concern for public health and safety.

    Plan B, unlike the RU486 pill and other drugs that terminate pregnancies already in progress, actually prevents the egg from implanting in the wall of the uterus, which is one of the conditions necessary for pregnancy to occur in the first place.

    Many women’s groups hope that by providing timely access to Plan B, women will be saved the trauma of abortion or giving birth to a children they cannot care for down the line. They argue for access to emergency contraception not as poorly-thought-out birth control, but as a defense against such situations as forced unprotected sex, rape, condom breakage and other situations where women are exposed to semen unexpectedly and do not wish to conceive.

    Alaska, California, Hawaii, Maine, New Mexico and Washington already offer emergency contraception without a prescription, and Plan B is available over the counter in more than 30 countries.

    Last updated: 31-Jan-05


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