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 : EC786
Submitter : Ms. Kathleen Pokorny Date & Time: 10/13/2005 08:10:31
Organization : Ms. Kathleen Pokorny
Category : Health Professional
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?
It does not matter what indication you say is safe for OTC use. People will use it for the prescription indications anyway. ESPECIALLY if they do not have prescription coverage - save on doctor visits and on medications (it's always cheaper once the med goes OTC). I would do the same myself. So you need to make sure that ALL medical conditions it can be used for are safe to treat without medical supervision. With current DTC ads from manufacturers, the info is readily available.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Aren't the H2-blockers already available both ways in prescription strengths? That shows existing FDA confusion. Either it is safe enough to take without medical supervision or it is not. Maybe the disease should not be treated without medical supervision, but the medication would otherwise be safe. Hasn't this been the case in the past?
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! You know that those underage would have a friend obtain it. This would open up the pharmacy to lawsuits. And is the federal government prepared financially to defend (and lose) its age limit in the Supreme Court? How will the FDA win such a lawsuit when, in this current medication situation, teenage girls can already obtain an abortion without parental notification/approval? Will you be able to show that the pill was more dangerous than the medical procedure she can already legally get?
B. If it could, would it be able to do so as practical matter and, if so, how?
No. Logbooks will not work. People lie when they fill them out. Then the friend will lie and say she really did buy it for herself. How is she going to be disproved? Shall the pharmacist witness the actual swallowing of the medication? In the case of other future medications, will the person need to return for daily witnessing?
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, because prescription items must carry the "unlawful to possess without a doctor's prescription warning". At least that part will need to be different. Or that law will need to be changed.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Any circumstance where you might want to see patients with prescription medication coverage continue to have it covered. The only people who might have a chance getting insurance reimbursement/payment are those who would be excluded from buying it as an OTC product.