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 : EC697
Submitter : Ms. Isela Madrigal Date & Time: 10/12/2005 06:10:28
Organization : High School Teacher
Category : Academia
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?
Yes, the FDA should initiate a rulemaking to codity its interpretation of section 503 (b)!
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?
Yes.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes, there is. After having taught Family Life to teens for 3 years now, many have admitted that they do not know what they are putting into their bodies and do not think about the harms it may cause later and the harms it is causing now, not only to them, but to the fetus within them.
Many teens have explained that they have taken other drugs, such as tylonal p.m. on numerous occassions to go to sleep. They think that because it is on the shelf at the store, it will not harm their bodies ever, even after taking it a number of times. There is no sense of temperance with in a teenage or most Americans
C. If so, would a rulemaking on this issue help dispet that confusion?
This drug should not even be offered.
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?
Probably not, which is why this drug should not even be made available!
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.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
It would be inappropriate under all circumstances.