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 : EC935
Submitter : Ms. LeAnna Benn Date & Time: 10/27/2005 08:10:19
Organization : Ms. LeAnna Benn
Category : Health Professional
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?
Why are any drugs prescription? If this is a higher dose than normal birth control, why not make all birth control over the counter?
Do women need the safeguard of perscriptions for birth control? If yes, then this drug needs to remain perscription controlled for all populations.
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?
Only if the industry wants to continue being perceived as being greedy for money and power.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes and the confusion is intentional on the part of those who want to give out the pills both by RX and by sales.
C. If so, would a rulemaking on this issue help dispet that confusion?
Thankfully, you are considering aspects beyond the clinical. That is a good first step. The irresponsible to relationships sex is as damaging as the STD spreading type sex. There is a sexual crises in America that impacts women and men too that should be curbed. Having to see a professional to assess the gravity of the situation may be an important cautionary step.
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?
no That is why the drug should remain behind the counter for all ages. It is an emergency drug, how many emergencies does a woman have? If there is a chance for abuse of this higher dosage drug, as something other than an emergency use, it should be tested for frequent use by several sub populations before being OTC for any group.
B. If it could, would it be able to do so as practical matter and, if so, how?
They would just shoplift it.
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?
no comment