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 : EC690
Submitter : Ms. Cheryl Abdullah Date & Time: 10/12/2005 06:10:21
Organization : n/a
Category : Individual Consumer
Issue Areas/Comments
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
B. If it could, would it be able to do so as practical matter and, if so, how?
I am very concerned that the FDA (1)Be liable for girls under 18 years of age who are victims of sexual abuse, molestation, incest, child pornography, and rape (including date rape), (2) Be liable for girls and adult women who repeatedly use "the morning after pill" *to have full knowledge of its effects* (so that people who believe life begins at conception fully understand they may be killing their child, and (3) be responsible, through testing and research, of adverse effects of the drug(s) *and provide this information to the public.*
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
Let's be frank: The FDA, in bowing to the pharmaceutical industry on this issue, is opening a huge and difficult-to-reverse can of worms. The FDA states in its invitation for comment the following:

"As an agency and as its Commissioner personally, I want to say
that FDA remains committed to making safe and effective
contraceptive products available to women and men who choose
to use them."

I cannot believe the above statement, as sincere as it may sound. You and I know fully well that Plan B is *not* contraception. It is an abortifacent. Also, the FDA approved RU-486, and women have *died* from this drug. It's still on the market.

I myself used the morning after pill when I was in college (approximately 1976). I became very very ill, as if with the flu. The "doctor" who gave it to me explained nothing other than how often to take it. And we can trust, from multiple sources, that "science" treats women like problems-if- pregnant, not as thinking human beings with a right to know exactly and precisely what is happening with their bodies and their lives. To wit, women (myself included) are actually "informed" in abortion clinics that a fetus is "just tissue." (And the pro-choice side accuses the pro-life side of ignoring science!)

Let's be wise here. Plan B should NOT be available OTC. Period. Planned Parenthood and other contraceptive suppliers have failed to regulate the bad effects of the free sex movement through drugs and plugs. Our nation's young people especially (my 25-year-old daughter included) are becoming infected at exponential rates with all sorts of sexual diseases that will probably last their lifetimes.

Whether to split the availability of Plan B at age 16 is a stupid focus. How many 14-year-old girls will be given these pills by 18-year-old boyfriends with the "scientific" advice "take these for three days at breakfast"? This is a brave new world, one in which young women learn, rapidly, that to be loved they must have sex and to get pregnant is bad. Our government is not helping them. Our government, like so many guys who just want to use women, will be complicit in the marketing of women, not drugs.

Thank you for listening to my voice. Count it as from a 50-year-old woman who understands through experience the ill effects of contraception. I almost died of peritonitis from an IUD in 1976--and the IUD is still on the market, too.

Do the world a favor: scrap Plan B as OTC.


Cheryl A. Abdullah