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 : EC809
Submitter : Mrs. Elizabeth McGrane Tran Date & Time: 10/13/2005 09:10:57
Organization : Mrs. Elizabeth McGrane Tran
Category : Individual Consumer
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?
There may be certain instances when offering a drug in the same dosage both as a prescription and OTC may be appropriate. However, I believe this should be done with extreme caution, concidering not only convenience to the population, but also the ramifications on our culture. Every possibility of abuse by every age group should be addressed and taken very seriously, using more than just the label to get warning messages to consumers. If initiating a rulemaking on section 503(b) would help clarify the process of discernment when drugs are concidered for simultaneous marketing, then yes, a rulemaking should be done.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Maybe some.
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?
I seriously doubt such a limitation could be effectively enforced. Just as under-aged smoking and drinking are such huge problems in our country, I believe a similar epidemic would occur. Even with laws in place, teenagers have moderately easy access to cigarettes and alcohol, often through older friends, or sometimes even parents, who will make the legal purchase for them. Enforcement of an age-only restriction on drugs, such as Plan B, would likely be just as ineffective.
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, they should be in different packaging.
Please keep Plan B available by prescription only. The thought of the ramifications of such a product being offered OTC is frightening. By the time my two children are teenagers, its effects on the spread of STD's and teenaged sexual activity could be enormous and irreversible. As a 28 year-old, I'm not so far removed from my teenage years that I don't remember what it was like. As a mother of a 2 year-old and a 6 month-old, I am afraid for my children and their peers if this drug is offered OTC.