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 : EC2055
Submitter : Ms. Liza Zamd Date & Time: 10/31/2005 05:10:18
Organization : Ms. Liza Zamd
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?
The FDA should allow the sale of over the counter emergency contraception without prescription requirements.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The confusion lies in the FDA's attempt to stymie the approval of over the counter emergency contraception.
C. If so, would a rulemaking on this issue help dispet that confusion?
No, a rulemaking would only serve to prolong the misguided debate over emergency contraception.
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?
Although minors have abridged rights, the implications of a prescription requirement go beyond the normal social guidance a society seeks to provide. The ramifications of a prescription requirement for minors may practically ensure that dozens of teens who have already engaged in sexual intercourse will then be faced with an unwanted pregnancy. Creating a prescription requirement will not incentivise teens to postpone sex, but will instead perpetutate the need for abortions.
B. If it could, would it be able to do so as practical matter and, if so, how?
A prescription requirement may have unwanted effects on the non-target population for adult teens may not seek emergency contraception if asked to prove their age, because they will then be forced to reveal thier identities. This, of course, also holds true for minor teens who will be obliged to reveal thier names and perhaps other information to a possibly hostile pharmacy worker.
GENERAL
GENERAL
Although those who seek to limit emergency contraception do so out of concern for teens, thier approach is misguided for they are perhaps forcing unwanted pregnancies onto a population less capable of rearing and supporting a child. Emergency contraception provides a compromise between those who believe abortion should be outlawed and those who seek to limit unwanted pregnancies. Teens who engage in unprotected sex, or those who are raped, are no less worthy of bodily autonomy as thier older counterparts. The time window is so narrow for emergency contraception that even adults may find it difficult to schedule an appointment with a doctor, and teens who cannot drive or do not know how to make such appointments will therefore miss the opportunity to prevent a pregnancy.