2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC811
Submitter : Mrs. Kiera Camron Date & Time: 10/13/2005 10:10:41
Organization : Mrs. Kiera Camron
Category : Individual Consumer
Issue Areas/Comments
The comments below were published in the "Tallahassee Democrat" on September 9, 2005. The author is Kiera Camron, responding to an editorial by Mary Ann Lindley.

Mary Ann Lindley calls the morning-after pill, or ?emergency contraception? (EC), a ?blessing.? Apparently, her definition of ?blessing? and mine are opposites.

Many descriptions of the various methods of EC call these regimens ?mega-doses? of the chemicals found in daily birth control pills. (For example, the ?Plan B?EC kit?s two pills, to be taken 12 hours apart, contain the same amount of levonorgestrel that a birth control pill user would ingest in about 20 days.) It follows, then, that EC users could experience many of the same serious side-effects that birth control pill users can experience (blood clots, strokes, heart attack, tumors, even an increased incidence of sexually transmitted disease) and then some: add inconvenient nausea and vomiting and even the potentially fatal ectopic pregnancy. Women who have historically suffered from a variety of health issues or who smoke are more vulnerable to the dangerous side-effects of EC.

EC is also contraindicated for routine contraceptive use, so it?s not safe to use over and over again in the place of other contraceptives. But women?s lifestyle choices could be significantly altered if they have some sense of ?safety? because they perceive EC to be a ?back up.? Poor choices and risky behaviors are associated with sexually transmitted disease infection, including HIV, and particularly among people under age 25, where two-thirds of STD infection occurs. Some sexually transmitted diseases are viruses that a woman will carry with her for the rest of her life; some cause dramatic damage to women, including sterility and cervical cancer. EC provides no protection whatsoever against these sexually transmitted diseases.

EC doesn?t stop at harming women; it harms the most defenseless among us, newly conceived boys and girls. Although Ms. Lindley claims that EC does not cause very early abortions, the FDA and the Alan Guttmacher Institute say that it can interfere with the implantation of early embryos. Both concur that, among several mechanisms, EC may work by either interfering with an embryo?s movement through the fallopian tube toward implantation in the uterus or by changing the lining of the uterus, making it inhospitable to the embryo. That new life is lost to his or her parents, and to the world. What is worse, he or she is lost without anyone?s knowledge because EC proponents obscure the truth about this mechanism of the drug.

Despite all of these risks, proponents are agitating (loudly) for these drugs to be made available over the counter, available without the advice of a medical professional who would provide vital education and assessment of a woman?s risk. The well-being of Americans is at stake; it is the FDA?s responsibility to ensure the involvement of medical professionals and prevent the over the counter sale of EC.

Planned Parenthood claims that EC will prevent 1.7 million unintended pregnancies and prevent 800,000 abortions each year in the United States, yet studies in the prominent medical journal The Journal of the American Medical Association and others in countries where EC has routinely been used for years show no change in pregnancy rates with over the counter availability of EC. So why the stubborn promotion of EC? What agenda could possibly justify the exploitation of American women?

I, for one, am thankful for the FDA taking the time to look more carefully at this dangerous drug. With any luck, they will conclude that over the counter EC is one ?blessing? America can do without.