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 : EC643
Submitter : Mrs. Dixie Conner Date & Time: 10/12/2005 06:10:02
Organization : None
Category : Individual Consumer
Issue Areas/Comments
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes, I don't even understand questions "A." I can state that females of any age are going to suffer health problems, possibly death, if more pregnancy preventive drugs and/or abortion drugs are made available. Also, the availability of these drugs encourages more young people to engage in sexual relationships and we all know those results...they may not get pregnant but many, many are contracting sexually transmitted diseases that will affect their health the rest of their lives. We should be advocating abstinence until married not encouraging more sex by offering abortion drugs. Mental health and physical health are more important issues.
C. If so, would a rulemaking on this issue help dispet that confusion?
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?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
All circumstances