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FDA and Plan B Decision Making

In May 2004 the Fda Denied the first application from the Women's Capital Corp. asking for the over the counter sale of the emergency contraceptive, Plan B. The rights to the Drug where then acquired by Barr Pharmaceuticals. Barr amended the first application by proposing that the drug only be sold to those who are 15 year-old and older, and that those who are younger must have a prescription.

The FDA responsed by saying that they were unsure if an age limit was legal or enforceable, leaving the decision for over the counter sales still in limbo. Part of the reason why the FDA is so wary about allowing this drug on the market, according to USA Today, is that Plan B manufactures have not proven that the drug is safe to be used by girls under the age of 15. The only problem with this, is that two years prior the FDA denied Women's Capital Corp. from performing studies on girls much younger than 15.

How does the FDA expect Plan B to ever pass on to over the counter sales if the studies that are needed to prove or disprove the safety of the drug can not be performed. If this is what is holding Plan B back, I find it a lame excuse. The question is what is the real motive behind holding up the over the counter sales of Plan B? I understand that it is a scary thought that girls as young as 12 would ever need to use Plan B but it is occurring in our society. If these girls view themselves as old enough or mature enough to have sexual relationships they should have access to all the same options as an older woman would have. Just because a girl is young does not mean that they have no rights to their own bodies. It is up to us to better educate so that they won't put themselves in a position where any type of birth control is needed but Plan B will help to ease the stress on many women who are worried about unwanted pregnancy and also reduce the need for abortions.



This post first appeared on Roerunners, please read the originial post: here

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FDA and Plan B Decision Making

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