A high-ranking Food and Drug Administration official has resigned and abortion-rights groups are outraged after the FDA again deferred approval of Barr Laboratories’ morning-after pill, Plan B, for over- the-counter sales.
Susan Wood, director of the FDA’s Office of Women’s Health, complained that scientific and clinical evidence that the pill was safe, even for teenagers, had been overruled for political reasons. Supporters of the pill claim that it is medically safe and will reduce “unintended pregnancy rates” amongst teenaged and adult women. Powerful support for that stand came this week from the American Academy of Pediatrics. It released a policy statement which claimed that “emergency contraception has tremendous potential to reduce unintended pregnancy rates in teens and adults”. Citing data from the UK and European countries, it says that making the morning- after pill readily available does not increase teenage promiscuity.
But this is precisely the issue which concerns the FDA. The new Commissioner of the FDA, Lester Crawford, had promised to settle Barr’s application to sell the controversial drug by September 1. Barr says that it will market the drug only to women 17 and older. Crawford does not oppose this, but says that Plan B presents “many difficult and novel policy and regulatory issues”. The difficulty is that if teenagers still need a prescription but over-17s do not, how can the age limit be enforced?
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