2001P-0075 - Switch Status of Emergency Contraceptives from Rx to OTC
FDA Comment Number : EC817
Submitter : Mr. Breck Landry Date & Time: 09/24/2004 01:09:48
Organization : Crisis Pregnancy Services
Individual Consumer
Category :
Issue Areas/Comments
GENERAL
GENERAL
I am opposed to making EC into an OTC drug. The item is dangerous already to women, even with physician support. My interviews with women indicate that physicians rarely counsel in detail about physiology of drugs, and reproductive drugs are the worst of these because they are politically correct. They either presume women don't want to know or they are just too lazy to read and tell women. OTC EC will leave the girl or woman at the mercy of her desparate circumstance and her ability to read and understand package inserts. The FDA has been less than obvious about 'birth control' effects on a woman's body in plain language. Women could understand if physicians and packages of contraceptives were always and clearly saying in plain English, 'If fertile, sex acts can result in conception of a human embryo WITHIN MINUTES and this process is much too fast to stop with any pill. EC pills can and often do cause the woman or girl to loose a living, growing human embryo by preventing implantation which is the attachment of the embryo (the baby) to the womb. Even if EC does not interfere with implantation in this way, there is no way the woman can know it had a true contraceptive effect. In other words, you may not be preventing a baby, you may be loosing one or more babies and you will never know which it was, but you will suffer the complications all the same.'

The EC callers we get at our center are often unaware of EC's true physiology and the timeline for conception, implantation and the drug's effect on these events. They deserve the truth. The FDA's credibility is on the line.

The EC should be removed from the United States market for all the same reasons. It does not heal, it kills.

If EC were OTC, we could reasonably expect an increase in sex, unprotected sex, STDs, and the many complications that accompany drug use, especially when contraindications are not recognized and appreciated by the OTC user. We all know even the healthy candidate for EC can be hurt, and that is a shame.

In our area (El Paso), OTC will be even more dangerous because many women would not be able to read English warnings about EC and understand the drug's effects on her and her baby. When explained to them, women often appreciate knowing this and reject EC and contraception, and prefer abstinence or natural family planning offered by university-trained instructors. Having a baby is healthy for women and provides life- time risk reduction against deadly breast cancer. With adoption, no woman is required to be a parent. Some 4000 centers like ours stand ready to assist women with unexpected pregnancies. There are no fees for the services and no woman has ever returned to our center to express regrets for having her baby.

Respectfully submitted, Breck Landry