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 : EC699
Submitter : Mrs. Christine Lund-Molfese Date & Time: 10/12/2005 06:10:44
Organization : Mrs. Christine Lund-Molfese
Category : Individual Consumer
Issue Areas/Comments
1
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?
Making Plan B Emergency Contraception over the counter would create numerous problems especially with regard to keeping it out of the hands of minors. What mechanism do you have for enforcing a regulation that prohibits sale to minors?
1.
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?
My response is the same as above and must take this factor into consideration.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes, there is confusion on the FDA's part and it seems it will be impossible to enforce this regulation and keep it out the hands of minors; this is because not all minors have a state I.D. card or driver's license at age 17, and one can assume that to begin to require them to obtain one would be an unrealistic expectation for those imposing the regulation, not to mention the upheavel this would cause.
C. If so, would a rulemaking on this issue help dispet that confusion?
No. Practically speaking, such a rulemaking could not be realistically enforced; So, it would make no sense to try to make a rule to dispel confusion that could not be enforced. Now THAT is confusing! Also, imagine how it may be confusing to the mind of a minor that certain drugs can be sold over the counter but not to them because there are too many risks. Is a 17 year old more able to comprehend these risks better than a 16 1/2 year old? What about a girl who is two weeks away from her 17th birthday, would some pharmacists choose to let her have Plan B, since she is so close to her 17th birthday?!? How can you possibly regulate such an action?
2
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?
My response is the same as above.
B. If it could, would it be able to do so as practical matter and, if so, how?
It is not practically nor realistically possible.
3
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?
No! That is a discrepency in policy which negates the need for the regulation!
GENERAL
GENERAL
My furthur thoughts on this issue, particularly in regarding to the dispensing of Plan B OTC, are best summed up by reading the following: Wendy Wright, executive vice president for Concerned Women for America reports Greater access to Plan B does nothing to reduce surgical abortions according to recent research 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."

I oppose the marketing of Emergency Contraception in any form due to the health risks it presents, as well as the financial expense using my tax dollars. It is not in the best interest of women and especially not in the interest of teenage girls who are not mature enough to have access to such drugs which have proven to have dangerous side effects and terminate the life of a newly developing hum an person.