I consider myself to be a bit liberal in nature and thought and I try to take the attitude of open mindedness, which sometime I fail at miserably. But I really don't think that I missing the point here. I feel pretty safe in saying that this was a political decision and not a health one.

Have you figured out what I am ranting about as of yet?

If not I'll clue you in. On the 6th of May 2004 the FDA decided NOT to approve the over the counter use of Plan B (Note to readers: going to www.planB.com will bring you to a "coming soon" online dating agency!) I really cannot understand why and how the FDA did not approve this medicine for women that are of legal age. The FDA states that there is not enough data from the 13 to 16 year old groups to approve it, as they cannot be sure that it is safe. Fine! Than approve it for women that are over the age of 16, and those that are under that - make sure that they have a perception.

I have been reading many different points of view on this topic as of late. I (and pretty much everyone) really thought that when the advisory committee voted for approval that the FDA would allow it. Why? The advisory committee voted 23 to 4 in favor of making it over the counter. Some states allow pharmacists to prescribe it to women, as making an appointment to get into the Ob/Gyn can be less than easy. You want to talk about waiting a long time? Try calling and getting an "emergency" appointment, say for a UTI (Urinary Track Infection) you still may have to wait a few days. Usually they will tell you to call your GP or go to your local ER, trust me I had to the later once…not really my idea of a good time. Hanging out in the ER with everyone just so that I could pee in a cup and be told "Yup! That's a bad one!" No freaking kidding jerk…I could have told you that, no give the antibiotics and the pain medicine and lets get moving!

So getting back to the topic, for Plan B to be effective, you need to take it with in the first 72 hours of unprotected sex. You also need to take a pregnancy test before you take the pills, as if you are pregnant - the pills will do no good. I found this Pre-made "Questions and Answers" on the FDA's website for answering questions about why Plan B was not made OTC. Personally, I had to laugh at the spin masters on this one...

"Q: Dr. Steven Galson signed the letter FDA sent to the sponsor. Does Dr. Galson usually sign such letters? Why did Dr. Galson sign the letter?

A: No, Dr. Galson does not usually sign regulatory action letters. However, his opinion of the adequacy of the data in young adolescents differed from that of the review staff. He believes that additional data are needed and for that reason he made the decision to take final action within the Office of the Center Director."

Oh, and do I really need to remind people why exactly appointed him the "acting director"?

****I and just for those that were wondering - yes Dave has every right to kick my cute behind from here to the radio station for missing so many weeks, but there were a few outstanding family issues that I was dealing with. So, Thanks Dave and WGAY for being so understanding.

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