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FDA Official Resigns Over Delay In Approval of Emergency Contraception

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During his Senate confirmation hearings, Food and Drug Administration Commissioner Lester Crawford pledged to Congress that if confirmed he’d see to it that the FDA would issue a decision by September 1 on whether to approve the “morning after” contraception pill Plan B. But on August 26, the FDA announced a new 60-day comment period that would delay its decision well past the stated deadline. And today, the Associated Press reports that Susan Wood, director of the FDA’s Office of Women’s Health, has submitted her resignation in protest over what appears to be another instance of the Bush Administration overruling the opinions of its own scientists.

Despite Crawford’s pledge, and despite the FDA’s finding that “the available scientific data are sufficient to support the safe use of Plan B as an OTC [over the counter] product … for women who are 17 years of age and older,” sexually active women and couples will have to continue to wait and see if they’ll ever be able to acquire the drug, which is manufactured by Barr Pharmaceuticals, over the counter. “I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled,” Wood said in an email.

Plan B uses a high dose of the hormone levonorgestrel (which is used in lower doses in traditional birth control pills) to prevent the fertilization of an egg after intercourse has occurred.

Opponents of making Plan B available without a prescription have cited a concern that girls under seventeen would be more likely to engage in “risky behavior” (in other words, sexual intercourse) if they had access to a day-after pill, increasing their risk of catching sexually transmitted diseases. But Wood and other women’s health advocates claim the FDA’s delay is political and has more to do with the Government’s anti-choice agenda. That the availability of dangerous and deadly addictive drugs like alchohol and tobacco without a prescription seems to mean so little to these allegedly “pro-life” activists and politicians, whose concern for the well-being of fertilized eggs seems always to trump any concern they may have for humans who already exist, makes their supposed worry about STDs seem disingenuous at best.

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About Jon Sobel

Jon Sobel is a Publisher and Executive Editor of Blogcritics as well as lead editor of the Culture & Society section. As a writer he contributes most often to Culture, where he reviews NYC theater; he also covers interesting music releases. Through Oren Hope Marketing and Copywriting at http://www.orenhope.com/ you can hire him to write or edit whatever marketing or journalistic materials your heart desires. Jon also writes the blog Park Odyssey at http://parkodyssey.blogspot.com/ where he visits every park in New York City. And by night he's a part-time working musician: lead singer, songwriter, and bass player for Whisperado, a member of other bands as well, and a sideman.
  • oh the punchlines from this news almost write themselves.

  • anna

    Why am I not surprised about another FDA delay? Convenient confusion over the safety of the morning after pill, Plan B, feeds the controversy. For starters, saying it’s a “high dose of hormones” sends up red flags raising safety concerns. Plan B contains levonorgestrel the same hormone in the Depo Provera shot, which is given in a 3-month dose. Compared to Depo, Plan B is a very small, short term dose of LNg, the effects of which are shortlived. Levonorgestrel is a progestin, which is a hormone needed to maintain a pregnancy. Lng has been given to women at risk of premature birth in short term doses to delay childbirth. A recent study published in Fertility & Sterility showed the fetus was unharmed from exposure to hormonal EC. Plan B is safe, effective, and not harmful to the fetus if pregnancy occurs inspite of dosing. It really is safer than many other substances available without a prescription.
    So I applaud Susan Wood for her courage to take a stand from within the FDA. Who better than an insider to expose this administration’s misguided mission to save the embryo when we have the technology to prevent unplanned pregnancy and the need for abortion. The grander cause is saving children born into this world from neglect, abandonment, abuse, and death by making sure every pregnancy is an intended one.

    Signed, Perplexed

  • Great article Jon. I had an article on this unbased delay by the FDA a few days ago. This is nothing but right-wing politics not accepting science like the rest of the world.

  • Once again, the Bush Administration has decided to elevate pandering to Christian conservatives above scientific merit and above womens’ health and welfare. The worst hypocrisy is that by not making Plan B more widely available, unwanted pregnancies that could have been prevented will instead become abortions that could have been avoided. Nobody should want more abortions. But the holy logic of the ‘culture of life’ is above concern for such ‘reality-based’ consequences.

    A process that should be grounded in medical science has instead been held hostage to a fine point of theological debate. Does life begin when the egg is fertilized (known in theological debates as ‘ensoulment’), or when the fertilized egg is implanted in the uterine wall and begins to grow? Plan B prevents the latter from occuring, thus preventing pregnancy. But those who believe that ‘ensoulment’ occurs at fertilization see prevention of implantation of a fertilized egg as a murder. The simple fact is that an IUD does the exact same thing, but rationality has nothing to do with this decision. Thus Plan B gets punted down the road in order to pander to a fine point of theology.

    People are upset and disappointed at the prospect that religious law may soon govern Iraq, but they would be do well to heed the creeping supremacy of religious law in America.