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Franken, 13 Other Senators Ask For “Rationale” On Plan B Decision

Franken, 13 Other Senators Ask For “Rationale” On Plan B Decision

Despite the Food and Drug Agency’s recommendation to allow Plan B, a form of emergency contraception that would prevent pregnancy if used within 72 hours of having unprotected sex, to be sold over the counter to women and girls of all ages, the Obama Administration overruled the agency, refusing to allow it to be obtained by girls under the age of 17 without a prescription.

Now, Senate Democrats are asking Secretary of Health and Human Services Kathleen Sebelius to explain her reasons for overruling the agency and its multiple scientific findings on the drug.

In a letter addressed to the Secretary, and signed by fourteen Democratic senators, including Minnesota Senator Al Franken, the group questions whether it was science or simply politics that made the final decision for the administration.

“We are writing to express our disappointment with your December 7, 2011 decision to block the Food and Drug Administration’s (FDA) recommendation to make Plan B One-Step available over-the-counter. We feel strongly that FDA regulations should be based on science. We write to you today to ask that you provide us with the rationale for this decision.

As numerous medical societies and patient advocates have argued, improved access to birth control, including emergency contraception, has been proven to reduce unintended pregnancies. Nearly half of all pregnancies that occur in the United States each year are unintended. Keeping Plan B behind the counter makes it harder for all women to obtain a safe and effective product they may need to prevent an unintended pregnancy.

We ask that you share with us your specific rationale and the scientific data you relied on for the decision to overrule the FDA recommendation. On behalf of the millions of women we represent, we want to be assured that this and future decisions affecting women’s health will be based on medical and scientific evidence.”

Sebelius has now said that the company can reapply to have the age limit removed once they come back with more testing proving that the contraception will cause no harm to girls between the ages of 11 and 17.  “There are always opportunities for the company to come back with additional data. Subsequent discussions can take place.”

However, the drug company has already done testing to the satisfaction of the FDA, according to
Commissioner Margaret Hamburg, M.D. “The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step.  Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.”

The fourteen senators who petitioned Sebelius are Franken, Sens. Patty Murray (Wash.), Kirsten Gillibrand (N.Y.), Barbara Boxer (Calif.), Richard Blumenthal (Conn.), Daniel Akaka (Hawaii), Carl Levin (Mich.), John Kerry (Mass.), Tom Harkin (Iowa), Al Franken (Minn.), Frank Lautenberg (N.J.), Ron Wyden (Ore.), Maria Cantwell (Wash.), Jeff Merkley (Ore.). and Sen. Bernie Sanders (I-Vt.).

 

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68 comments

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1:04PM PST on Jan 3, 2012

Thanks for this information.

11:20AM PST on Dec 18, 2011

Sen. Franken refused to Vote Yea in favor of H.R. 1540 (National Defense Authorization Act).

With the signing of this most draconian Bill, any American can be arrested by the Military and held infinitely, in an undisclosed detention/interment camps

Do you know that America has more people in Prison than all the nations of the World.

4:56AM PST on Dec 18, 2011

Lilithe M - who said a young girl that has been raped should not be able to terminate her pregnancy?

Not me!

Tell us - how many girls 10, 11, 12 years - even 16 years of age, go buy their own Nyquil or other drugs?

And if you think Nyquil is more dangerous that Plan B - you're seriously delirious!

Read about the dangers here: http://www.medicinenet.com/levonorgestrel-oral/page2.htm and then come back again and tell us it's okay for a young girl to take it without being closely monitored by a parent or doctor!

Hell yes I would be freaked out about my 10 to 16 year old daughter having sex if I had one, and potentially screwing up her whole life! I'd be even more freaked out if I thought she could walk into a drugstore and buy Plan B without her doctor's okay!

And for your information, I have two sons and two daughters, all older than you - who were all well educated and informed about sex and reproduction before the age of 10, and they are as horrified about the liberal attitude towards this drug as I am!

It SHOULD be available to young girls - but by prescription from a doctor only!

End of story!

2:53AM PST on Dec 18, 2011

This whole debate is not about abortion. It's about allowing a young girl- 10, 11yrs, etc, buying something OTC. So, a girl w/out a driver's license can buy something that must be fairly strong btw & may very well hurt her b/c of something in her own body (DNA) or something that conflicts w/anything else she may already be taking. IF a Dr were to Rx it for her (w/out parental consent) then ok. IF her parent said it was ok, then...ok. I personally think this morning after pill is a good thing & will hopefully help bridge the gap b/t the choice & anti-choice grops. But it has to be done safely & responsibly...

So, simply put- where SHOULD the age limit be? I just Googled "youngest prenancies." One site showed the youngest known birth was in Peru- age 5!!!!!!! Then 8, 9, etc...!!! So where do we draw the line? Obviously we'd draw the line on the other side as "r-a-p-i-s-t" unless the offending male were w/in a yr or so of same age... Still, would anyone here think it ok for a ~7yr old to walk into a store & buy one of these pills & take it w/out Dr or parental consent? Lines have to be drawn somewhere. Where do we draw it here?

Here's the link:
http://answers.yahoo.com/question/index?qid=20080701034238AAvFJJr

2:31AM PST on Dec 18, 2011

Steve R. - if a young girl has been raped by her father or uncle or a stranger etc - then she should have the right to terminate if she gets pregnant. End of story. If she can buy Nyquil, and other drugs that can have far more deleterious effects, then she should be able to access Plan B.

I think you are just freaked out at the idea of your daughter having sex, and find shame in it rather than the beauty it is. Get over it. Giver her condoms and information (which I would imagine you would do for a son) - that will help her far more than your Victorian papa bear BS.

11:56AM PST on Dec 17, 2011

Teresa W - "all drugs are potentially dangerous".... and your point is????

Let's just allow 10 year olds to buy them all without restrictions why don't we??

Unbelievable!

11:54AM PST on Dec 17, 2011

Heather G - the point is NOT that it doesn't cause abortions - the point is WHETHER IT'S RIGHT to allow underage girls probably as young as 10 to buy the crap over the counter without ANYONE'S knowledge or permission!!!!

If that's okay for your daughters, have at it! RESPONSIBLE parents are NOT OKAY with it!

10:27AM PST on Dec 17, 2011

Steve, all drugs are potentially dangerous, even aspirin...

10:26AM PST on Dec 17, 2011

Sending a Green Star is a simple way to say "Thank you"

You cannot currently send a star to Heather because you have done so within the last week.

10:21AM PST on Dec 17, 2011

The point is that Plan B does NOT cause abortions!!

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