Breaking: Sebelius overrules FDA – morning-after pill will NOT be made available to kids without a prescription
Here’s the letter from FDA Commissioner Dr. Margaret Hamburg. Excerpt:
I reviewed and thoughtfully considered the data… 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.
Abortion proponents are in shock. So am I, although in the opposite direction. From Bloomberg:
The decision follows by two years a federal court ruling that age restrictions on the pill were arbitrary, based more on political pressure than safety.
This was the same charged leveled against President Bush’s FDA for dragging its feet to make Plan B freely available to adults.
Now what can proponents say?
Nevertheless, I await the other shoe to drop. Perhaps there is just a technical glitch. We’ll see.
UDPATE: Here’s Sebelius’s letter. It states studies have not been conducted on all ages to determine the impact of a megadose of female steroids on the adolescent female body.
Jill Stanek is a nurse turned speaker, columnist and blogger, a national figure in the effort to protect both preborn and postborn innocent human life.
If Plan B is available on pharmacy shelves, girls won’t go to Planned Parenthood to get it. That could be the reason for this internal pro-abortion conflict.
Ah… Kelsey… interesting… although PP pushed to make it available over-the-counter for adults… which I never understood.
Wouldn’t over the counter for very young women mean that even 11-14 year olds could easily be forced to take it by abusive statutory rapists? Also, approving it would be ammo for the upcoming election. I mean, talk about enabling and covering up for rapists of very young women. It seems the opposition could really run with this. She seems to be asking rather directly for some documentation to cover herself when this comes up for debate, and it will come up.
That’s a fair point, Jill. Perhaps Planned Parenthood is experiencing some lobbyist’s remorse? After all, this is their “toughest year ever.”
Mind you, this is all just educated guessing. Few things override Sebelius’ commitment to liberal positions on women’s health; her commitment to Planned Parenthood is one of them.
Speaking for myself, I tend to be a bit skeptical when a drug company pushes for their prescription drug to get over the counter status. I always feel it is profit driven and not always in the best interest of patients. I think Sebelius is 100% correct in that plan B should require a medical consultation to explain how it works and any risks of side effects. I do not however have any problem with tele-med conferences to obtain plan B. They are doing teleconferencing of specialist during major surgeries now and if they can consult on a surgery in progress then talking to a Dr. via video conferencing to get plan B and all the medical info is also ok with me.
Whatever the reasoning, I’m glad they’ve taken this step. If Plan B were available on the shelves all sexually active teens would have to do to avoid having to talk to their doctor would be to buy Plan B on a regular basis.
Biggz, I believe you’re confusing Plan B with RU486. Nevertheless, I’m pleased you agree with Sebelius. I’m shocked I agree with Sebelius.
Jill, No not confused. I have no problem with tele-med for RU486 or Plan B. In both cases we are not talking about advil here, these drugs have major effects “as they are intended” to any woman taking them. A doctor should know you are taking them in case of complications. All meds of this caliber should be under the advice of a doctor. Also I must admit that I too have some concerns about some dumb jerk slipping these drugs into his girlfriend drink or some dumb girl wanting to be overly cautious and taking more than the recommended dose. Yes these issues may still come up with the way you have to get them now but at least if go into a clinic to get them you have a medical professional to tell you the risks and the no no’s.
I actually posed this to Amanda Marcotte, who responded with the fair point that “The various orgs in this world watch each other very carefully and interact a lot. There’s no hiding a bomb like that.” So I retract my hypothesis. Anyone have an alternative explanation?
This is a good but hallow victory. As long as minor girls can get ‘the pill’ from a doctor, clinic, or PP without parental they can already get ‘plan B’ without anyone the wiser. I have heard multiple sexually active teenagers say ‘don’t worry, just take 3 or 4 birth control pills the morning after sex, then you don’t have to remember to take it every day’ the fact that plan B is just a ‘mega dose’ of the pill was already well known to my peers when I was in high school in the late 90’s/early 2000’s. I now have known grown women who do the same thing because it’s easier than going and buying plan b the day after. They just take bc ‘when they remember’ to help with their periods and then take a handful to ‘catch up’ after a sexual encounter.