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 : EC659
Submitter : Mr. Willis Langford Date & Time: 10/12/2005 06:10:49
Organization : Self-Employed
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?
Dear Commissioner:

Perhaps (it will be an enforcement nightmare, and thus it will not be controlled. Older kids will give to younger ones), therefore, it must not be allowed for minors. What 16 y/o has a brain to make such a decision? Besides, your own scientists state it is unsafe for any under 17 (basis not revealed).

This is a parental responsibility until she is mature and/or the one buying for another is mature. Hopefully, this will reduce enforcement problems somewhat. What do we do with the "lawbreaker"? Put her in jail? What about the kid who is buying these damned pills several times a month? How safe is that? What is the death rate of unsupervised users? You have told us nothing of these answers.

Why must the Public make these decisions that you are being paid to make? Supposedly, you have the science, we have nothing but gut feelings about our daughters to guide us. Why are you going against your own scientist and asking us to approve over-the-counter usage by a 16 y/o for whom it is deemed unsafe by your own people? Bite the bullet. or get out of the kitchen. Nevertheless, don't be stupid and give this to anyone whose brain is not sufficiently developed to be deemed mature. Until the child is mature, it is a parental responsibility to make this decision for their daughter.


Lcdr. Willis S. Langford, USNR (ret)
Father of 4 (3 daughters), grandfather of 8, Greatgrandfather of 15.
3579 Santa Maria Street
Oceanside, CA 92056
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?
Only if the cutoff age is maturity.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I don't believe you told us of your interpretation. You seemed to be asking us to make that decision.
C. If so, would a rulemaking on this issue help dispet that confusion?
Now, you are really confusing us. You are asking us to determine what that rule should be and now you ask this question?
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?
No. and what would you do with the millions of rule breakers?
B. If it could, would it be able to do so as practical matter and, if so, how?
Impossible. Even if the 15 y/o honored the law by not showing her face, her 16 y/o friend would gladly buy it for her. This is just another encouragement to children to avoid parental supervision and to indulge in premarital sex. More to the point, this is another example of good judgement giving way to the greed of the drug maker. Wouldn't they love to have every girl-child irresponsibly buying their product several times a year? Let the Government sort out the enforcement. Take a page from our war on drugs, "Just Say NO!"
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?
You are the lawyer, not me, it would likely be ruled illegal.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
To anyone under 18.
See opening comments.