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 : EC1607
Submitter : Ms. Michelle Feltes Date & Time: 10/31/2005 01:10:01
Organization : Ms. Michelle Feltes
Category : Academia
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?
No. This drug should be sold as an OTC medication.
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?
Yes. It has happened with the nicotine patch. However, in the case of Plan B, it should be under the purview of the states, not the FDA,
B. If it could, would it be able to do so as practical matter and, if so, how?
Yes, it could be placed behind the pharmacy counter, so everyone has to ask for it. For those able to purchase it as an OTC, they would not need a prescription.
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?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
It would only be inappropriate to do so if the doses were different and thus required different medication times or had different side effects.
I think that Plan B should be sold as an OTC for everyone, not just 18+. It also should not have to go through this procedure at all. It is disgraceful that politics have entered into the FDA. The FDA is supposed to determine if a drug is safe as labeled. Since the scientific and medical reviewers have determined that it is, there is no reason to withhold this medication from the populace.