The FDA will not remove restrictions on access for the Morning After Birth Control Pill.
In a statement today, FDA Commissioner Margaret Hamburg said she was convinced that the product, called Plan B One Step, is safe and effective at preventing pregnancy after unprotected intercourse for women of all ages. Currently the product is available without a prescription only to those age 17 and over. As long ago as 2003, two FDA advisory panels recommended the product be made available over the counter without age restrictions.
Hamburg, however, was overruled by her boss, Health and Human Services Secretary Kathleen Sebelius. As a result, the drug makers’ application to remove the age restriction has been denied, and girls under age 17 will still need a prescription.
I would like to take this opportunity to request Sebelius resignation.
Margaret Hamburg’s statement is here. The most important part is here:
I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.
However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved. Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today. Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17.
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I’m an employee of the FDA, I keep their computers running.
I remember the Bush & Co. days when the FDA was regularly prevented from making science based decisions, constantly being foiled by political appointees who “corrected” our decisions based on political or religious reasons. FDA has always prided itself as a science based Agency, and for many of us who work here, that is a good reason to work for this particular Agency.
It infuriates me now to see that FDA has once again been foiled based on political considerations that should have NOTHING to do with the matter at hand.
Obviously, this is MY opinion, and has nothing to do with my employment or my employer’s opinions, public or private.
Greg, you know that the only people that need Plan B are sluts. Sluts need to be punished…with children. Or shrieked at when they get abortions.
Taking responsibility for a mistake/carelessness and doing the right thing must be prevented at all cost.
/What every socially conservative jackass is thinking…
Also, daughters are the property of their fathers, dontcha know. If a 16 year old girl can get birth control without a prescription, she can just go around letting other men put their penises in HIS PROPERTY and he won’t even know about it!
They do have a point…I mean…If some guy stuck his penis in your peanut butter without your permission you’d probably hate it and never want anything to do with that peanut butter ever again.
Why would you treat your children with such favoritism?
/snark
For whatever it’s worth, I was just notified of a change.org petition.
Thanks for the petition link.
Someone on a different blog mentioned that Sibelius was pro-choice… which seems unlikely to me.
Does anyone know?
I just assumed that Sibelius’s move was motivated by religion – do we know if that is the case?
She is absolutely pro-choice. Here, she is just bending to conservative pressure.
Wow! Pro-choice ~and~ bending to conservative pressure… I didn’t think that was possible! 😉
Thanks for the info…