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 : EC269
Submitter : Ms. Elizabeth Degoursac Date & Time: 09/20/2005 03:09:40
Organization : Emory University
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?
If it is for a very limited period of time, stated in advance and adhered to. And I question why it is brought up in this one instance which has already been controversial on religious and moral grounds which are not appropriate to consider with respect to medication that people need and want to protect their health.
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?
same as above, same question
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Perhaps
C. If so, would a rulemaking on this issue help dispet that confusion?
Yes, but in lieu of reconsidering the entire policy you could just make a ruling in the case of this one drug, to expedite making it available to those for whom the benefits outweight the risks and not available to those for whom the risks outweight the benefits. Especially since the risks to people under 17 are merely hypothesized without any evidence at all to support (or disprove) them.

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?
Easily if age or gender are the qualifying criteria. Just as we limit people from drinking or voting or signing contracts, so we can limit them purchasing certain medications.
B. If it could, would it be able to do so as practical matter and, if so, how?
People can vote and drive and drink at certain defined ages, and we require government ID or other proof of age to enforce these policies. It would be trivial to require that the drugs be kept at the pharmacist area (just like insulin and all sorts of other OTC items) and an ID be shown to purchase the items.

Just as we rely on adults to not purchase alcohol for minors, and make a law about it, we could make a law doing the same for drugs with an age limit.
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?
Yes, it is moot if you require ID before distributing it. No one will have it in their possession except those who showed ID or gave a prescription. If others have it due to an adult obtaining it for them, it is their risk and the responsible adult's - just like with alcohol.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
None
GENERAL
GENERAL
In lieu of reconsidering the entire policy you could just make a ruling in the case of this one drug, to expedite making it available to those for whom the benefits outweight the risks and not available to those for whom the risks outweight the benefits. Especially since the risks to people under 17 are merely hypothesized without any evidence to support (or disprove) them.

In fact, we have known lethal drugs that are sold over-the-counter all the time, most of them not tested fully in young people prior to coming to market: certain ephedra drugs that are lethal to teenage women, vitamins that kill thousands of kids every year due to overdose, advil which is lethal in doses easily purchased by anyone, lamisil which can be lethal to persons on anti-depressant medications by increasing risk of suicide. Heck, even food products on the shelves are selectively lethal, and yet we allow them to be sold. Peanuts which are lethal to people with allergies, chocolate and orange juice(lethal to people on MAOIs), honey which can kill a baby, hot dogs which can choke infants, etc.

I am sad that this hurdle has been raised specifically for this drug which already is controversial among evangelical christians. We must start being truthful about our motives and our intentions in governanace. Hidden agendas are not safe in government.