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 : EC670
Submitter : Miss. Alisa Craddock Date & Time: 10/12/2005 06:10:39
Organization : Miss. Alisa Craddock
Category : Drug Industry
Issue Areas/Comments
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
I oppose the sale over-the-counter of what is called the "morning after pill." If you make that available, then the next logical step is that all contraceptive pills should be made available OTC as well, and since over half of abortions are performed on women or girls who were using a birth control method that failed, it would add yet another false sense of security, in addition to health risks the woman may not be aware of specific to her.

A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
See above.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There is no confusion in my mind, I just believe you have to look at the larger picture--what impact will this have on population and health overall. It would be inadvisable to simply look at this through a narrow lens directed only at the rule of law, and whether it could be changed, rather than looking at the impact it will have and whether that impact is a positive or negative one.
C. If so, would a rulemaking on this issue help dispet that confusion?
I do not believe in the OTC distribution of contraceptives, period. That's the rulemaking I wish to see.
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?
The evidence suggests not.
B. If it could, would it be able to do so as practical matter and, if so, how?
I don't believe it could be enforced. There is too much effort in schools by people who are supposed to have the child's best interest at heart encouraging adolescent sexual behavior and taking the kids to get abortions. The kids will simply get them from the school or get a sympathetic adult to buy it for them. Unfortunately, sympathetic adults are all too willing to encourage minors in this respect.
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?
It will make no difference.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
No opinion.
Wendy Wright of Concerned Women for America has done some research in European use of the morning after pill. Here are her findings:

Greater access to Plan B does nothing to reduce surgical abortions according to a recent report she coauthored, which presents the findings of several studies on the topic. One of the studies from Scotland reported that "in Glasgow , morning-after pill prescriptions increased 300 percent from 1992 to 1999. Yet, abortions did not decrease. In Lothian, where schools handed out condoms and sent pupils to clinics for morning-after pills, teenage pregnancies among 13 to 15- year-olds soared 10 percent in one year."

Research from the UK also revealed that over the counter access to Plan B "coincides with surges in STD rates. In areas where a limited program began in 1999 . . . chlamydia cases rose from 7,000 in 1999 to 10,000 cases in 2002. Gonorrhea cases climbed nearly 50 percent, to nearly 3,000 cases in 2002 . . . Abortions increased by nearly 6,000 in a one year period, jumping 3.2 percent in 2003 from 2002, with the largest leap among girls under the age of 16."

Wright also says making Plan B over the counter would create numerous problems especially with regard to keeping it out of the hands of minors. "The FDA has no mechanism for enforcing a regulation that prohibits sale to minors," she said.

The attempt to get this product sold OTC is bald greed, and has nothing to do with providing health care to women. The abortion industry no more wants to prevent teen pregnancy than the tobacco industry wants to prevent teen smoking, and the drug industry is just as culpable.