NEWS: FDA Delays Decision on OTC Morning-After Pill

The U.S. Food and Drug Administration has delayed making the morning-after pill Plan B available over-the-counter citing a lack of studies on the safety of the pill when used by teenagers. The pill is a cocktail of hormones that prevent a fertilized egg from attaching properly to the uterus causing pregnancy. Proponents of making the pill available OTC say it will avoid unwanted pregnancies while detractors say it will encourage risky sexual behavior.



While pro-life myself, I must admit this is probably the least objectional form of post-conception birth control. However, given the current state of government controls on the drugs available over-the-counter under American law, I really can't see this gaining approval to be distributed without a prescription since hormone pills for birth control and post-menopausal use aren't available without a doctor's prescription either.

Related News Links:
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[edit on 1/22/2005 by djohnsto77]

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The FDA rushes approval of drugs with evidence of dangers that the big drug companies want. They even squelch internal agency objections, because their paychecks and funding come directly from the Drug companies themselves.

They also don't have any effective monitoring system to track drug problems once they are on the market. And when doctors repeatedly inform them of problems with on-market drugs they don't listen.

Now it comes to something politically sensitive and they take lots of time and dance all around.

Who thinks the FDA is a mercenary political pile of cheese wiz?

Do you trust the FDA with your life? Isn't your life worth more than that?
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Playing politics with women's health is criminal. The impending lawsuit filed against by the FDA by the Center for Reproductive Rights will show exactly that.

There is also no way that the FDA can keep this from becoming non-prescription. There is no argument from even the FDA that Plan B is safe and will cause no serious side effects. Every major medical organization in the country supports non-prescription use.

The concern is if it is misued by teenagers, resulting in frequent use. The misuse argument is a little misleading because a teenager would have to use Plan B virtually every day to have negative side effects, and at a cost of $15 to $25 per dose, that would be $5000 to $10,000 a year. What teenager has that kind of money? This isn't going to be used like birth control pills--a box of condoms is much cheaper.

Considering that Tylenol has more devastating effects in a single overdose, I wonder why this logic hasn't made them remove it from the market also. Every OTC drug will have consequences if it is misused--if the FDA was so concerned about public behavior, there wouldn't be any OTC medication available.

In addition, studies of Plan B in Europe show that repeated use is infrequent-- Less than 1% of 15,000 women studied in the U.K. that used Plan B used it more than three times over a three year period.

Plan B needs to be over the counter because it's effectiveness decreases by 50% after the first 12 hours after sex, and becomes less effective with each passing hour. Finding a doctor to write a prescription is sometimes difficult, especially over a weekend. Many women will have to go to a clinic to get a prescription, which adds cost and time. For teens, going to a doctor will also be a deterrent because of the fear that their parents will be called.

The morning-after pill prevents pregnancies and will reduce the number of abortions. I don't know why the FDA and the religious right (which have become the same these days) can't see that this is a good thing.

We have been discussing this all week at
www.abovetopsecret.com...'