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 : EC2107
Submitter : Mr. Duane Oyen Date & Time: 10/31/2005 06:10:50
Organization : N/A
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?
Yes. Please explain the effective difference between, for example, OTC ibuprofen and Motrin 600 with regard to prescription enforcement. This is neither new nor "molecular biochemistry" (a subject specific "rocket science" metaphor)
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- and in a realistic way, not as outlawing disguised as regulation.
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?
Society does it all the time with substances that are legal but limited to adults- cigarettes and alcohol, for example; prescription items are easier to track than those products. The enforcement in a free society is imperfect, as is enforcement of any law in a free society, but there are balancing tests that can be applied- risk versus cost, probability of misuse, penalties for fraudulent acquisition and use, etc. that will mitigate the problem.
B. If it could, would it be able to do so as practical matter and, if so, how?
The cutoff age should be 18, or 15 with parental approval- not 16. That means the parent buys and signs for it, not a minor under any circumstances. Over age 18, the person must ask at the pharmacy counter and sign a specific certification acknowledging that it is illegal to pass the compounds on to anyone else, and the signature is an oath not to do so, under significnat penalty of legal sanctions, including possible jail time.
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?
The different products should not be sold in the same packaging. There should be signficant alert notices on the OTC package and the rules regarding consumer eligibility shoud be broadly disseminated to enhance enforcement success.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
N/A
GENERAL
GENERAL
As with all liberty versus regulation issues, in a free country there should be a presumption that the public is not moronic, nor criminal, nor incapable of being responsible for his or her own life. There are a lot of places where things should be culturally discouraged but not outlawed- and morality is absolutely the first area to which that applies. We need the same campaigns against underage promiscuity that we have against smoking, but that is not a reason to play Big Brother to adults.

If the only criterion for illegality is the possibility that a drug might be improperly dispensed second-hand, we need to outlaw ALL pain medications, period.

But the parental rights to deal with minor children should not be curtailed under any circumstances. There is a point where the family has to trump the culture, and the law should enable that.