oh, the FDA…

Yesterday, the Food and Drug Administration announced that the Plan B One-Step contraceptive pill would be available to women ages 15 and older without a prescription.  This was a major step for the FDA, as Plan B One-Step is currently only available behind the pharmacy counter to women ages 17 and up.

Although the FDA advisory panel initially approved Plan B as an over the counter medication for women of all ages, many in the medical community were taken by surprise when Health and Human Services Secretary Kathleen Sebelius overruled the FDA’s scientists in 2011 and implemented the over 17 age rule.  That decisions recently came under fire from U.S. District Judge Edward Korman of New York, who blamed the Obama administration for imposing the age-17 limit as election-year politics instead of science.

The FDA claims the current 15 and up recommendation was already pending prior to Korman’s ruling, as the pharmaceutical company Teva had amended it’s initial application to the FDA.  But is the FDA’s current position any better?

Let’s consider the fact that FDA’s decision requires identification to verify age in order to purchase Plan B One-Step.  Anyone who can’t provide such proof as a driver’s license, birth certificate or passport wouldn’t be allowed to complete the purchase.  I wonder how many girls between the ages of 15 and 17 lack a driver’s license (certainly all of the 15 year olds) or a passport (probably a decent number).  And how many of them have easy access to their birth certificate without having to ask a parent for it first?

In the words of Nancy Northrup, president of the Center for Reproductive Rights, lowering the age limit ‘‘may reduce delays for some young women but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification.”

For the whole gambit of reactions, click here.


About justgngr

the ramblings of a medical professional by day, judgmental ginger by night
This entry was posted in health policy, medicine, politics. Bookmark the permalink.

2 Responses to oh, the FDA…

  1. Judge Korman’s decision is still true. It’s politics trumping science.

  2. sqhc says:

    Reblogged this on Students for Quality Health Care and commented:
    what are your thoughts on the FDA’s decision? Great step in the right direction? Not enough, or is it too much too soon?

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