FDA May Remove Age Restrictions From Morning-After Pill Plan B

[thundley4]

The Food and Drug Administration (FDA) may move to eliminate age restrictions for the morning-after emergency contraception pill, Plan B One-Step, according to several people involved with the deliberations who spoke with TIME Healthland.

The morning-after pill is currently available without a prescription to users aged 17 or older. Younger teens still require a prescription. If the FDA does away with that restriction, it could bring the emergency contraception pill from behind the pharmacist's counter to store shelves, alongside more familiar over-the-counter medications like antacids and painkillers.

In February, Plan B's manufacturer, Teva Pharmaceuticals, filed an application with the FDA to move the pill from "dual label" status, which requires it to be sold under hybrid over-the-counter and prescription-drug regulations, to full over-the-counter status, which would remove the age restriction. As part of agency policy, an FDA spokesperson declined to comment on the case, but people close to the process expect the agency to meet the deadline for announcing its decision on Wednesday, Dec. 7.

Such a change in labeling has been long anticipated by public health experts and many legislators, who have urged the FDA to widen women's access to emergency contraception since at least 2003, when Plan B's manufacturer first asked the agency to make it available over the counter to consumers of any age. That decision was three years in the offing, mired in a national debate over reproductive rights. Abortion-rights groups said increased access to emergency contraception would lower the rate of abortion in the U.S., while anti-abortion groups predicted the opposite, warning that it would lead to more abortion and encourage riskier teen sex.

Despite an FDA advisory council's recommendation in 2003 to allow prescription-free sales of the drug, the FDA repeatedly delayed its decision, in large part to appease the conservative anti-abortion faction, many critics said. In 2006, the FDA finally made the morning-after pill available without a prescription to women aged 18 or older. In 2009, the age cutoff was lowered to 17.

http://healthland.time.com/2011/12/06/fda-may-remove-age-restrictions-from-morning-after-pill-plan-b/

WTF?  It's more difficult to buy cold medicine than this. Just last week, I was asked for my birth date when I bought a pocket knife at K Mart.

[Rebel]

Hell, it's more difficult to buy spray paint in some areas, mine included.

[cmypay]

I am at a loss as to why a minor (CHILD) would be allowed to buy this pill. Although, the government has already decided that the school can give my child birth control without my permission, including the pill (or other hormone based birth control) AND/OR transport said child to an abortion clinic.

[DefiantSix]

Hell, it's more difficult to buy spray paint in some areas, mine included.

To say nothing of all the hoops you have to jump through to get a box of cold remedy.

[compaqxp]

To say nothing of all the hoops you have to jump through to get a box of cold remedy.

I'm confused, how hard could it be? Here you go in a grab some off the shelf and pay, no questions. I take it they have restrictions but they can't be that bad...

[thundley4]

I'm confused, how hard could it be? Here you go in a grab some off the shelf and pay, no questions. I take it they have restrictions but they can't be that bad...

Anything containing sudafed  (Pseudoephedrine) is kept behind the counter in Illinois.  You are limited to buying two products containing it, too. You have to show an ID and records are kept, too.

[DefiantSix]

Anything containing sudafed  (Pseudoephedrine) is kept behind the counter in Illinois.  You are limited to buying two products containing it, too. You have to show an ID and records are kept, too.

Same here in Colorado.

[thundley4]

Supposedly , Sebellius has overruled the FDA and the rules won't be changing. Wonder if some election might have influenced her opinion?