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To: exDemMom
“I wonder, can women and their families sue this judge for damages resulting from using this drug in a way never intended when the FDA approved its use?”

I bet this is one of those products that comes with a label saying that it's a violation of federal law to use other than as directed. At some point there must be personal liability for what we do.

“This judge's opinion should not be allowed to trump the science-based regulatory decisions of the FDA. I would hope the head of the FDA stands up and says that the FDA refuses to change its recommendations without a good solid scientifically informed reason to do so.”

It was the FDA that issued a science-based regulatory decision that this should be OTC. The Obama Administration stepped in and made a self-admitted and “purely political decision” to restrict OTC sales because they thought it would be more popular.

15 posted on 04/06/2013 4:30:35 AM PDT by texanred
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To: texanred
It was the FDA that issued a science-based regulatory decision that this should be OTC. The Obama Administration stepped in and made a self-admitted and “purely political decision” to restrict OTC sales because they thought it would be more popular.

It was not the FDA's original ruling that this drug be sold OTC. The second paragraph of this article mentions it. I'm providing the link to another article that explains the situation in more detail, but this article is only available to subscribers. The FDA committees that reviewed the drug could not come to an agreement on whether it should be granted OTC status. The studies mentioned in the subscriber-only article examined the behavior of groups over a period of 6 months, during which they may have used Plan B one or more times. There are no studies mentioned regarding the health effects of using Plan B several times a month over an extended period of time.

The political pressure on the FDA began in the early 2000s.

I am going to guess that the committees that reviewed the data were not concerned with the effects of a one-time use of the drug, but had the same concerns that I do. That a small subset of women will assume that OTC=perfectly safe, and pop one of those pills every time they have intercourse. In the case of a married woman, that could end up being several times a month, in which case that drug can pose serious short- and long-term health issues.

34 posted on 04/07/2013 5:41:32 AM PDT by exDemMom (Now that I've finally accepted that I'm living a bad hair life, I'm more at peace with the world.)
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