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 : EC779
Submitter : Miss. Megan Macdonell Date & Time: 10/13/2005 08:10:47
Organization : Miss. Megan Macdonell
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?
There are many medications that have the same active ingredient available in both a generic/OTC method as well as through prescription. With that said I am also unaware of the guidelines by which these decisions are made, however I do not personally see it as a problem. I believe that there should be a "re-wording" of section 503(b).
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?
I believe that a controversial product like Planned B should be placed behind the counter (at the register) to control the buyers age of this product. I am from Oregon, and here our legal age to buy cigarettes is 16 years of age. I believe that if this product was kept behind the counters (literally) that this will prevent theft and the ID's of the buyer can be checked before the product can be purchased. If the consumer does not have a Drivers License or and ID with their birthdate on it, then I believe they should need a form of proper identification that includes their date of birth.
B. If it could, would it be able to do so as practical matter and, if so, how?
I do not believe that the process I described above is unpractical or difficult to accomplish. I believe that cashiers just need to be trained at looking for proper ID's (which generally they are) as well as the use of discretion while serving these consumers.
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?
I believe that they should be allowed to be sold in the same package. I also believe that perhaps the packages that are sold in stores should have information about the risks of this medication and facts about why this is called emergency contraception, and that it in no circumstance should replace normal contraceptive measures. The subpopulation under 16 who would get it through prescription will have their doctors explain these facts. So I do not believe that it would hurt to have an extra procautionary measure included in the OTC meds.
GENERAL
GENERAL
I believe that making the Planned B birth control available without a prescription to women age 16 and older is a progressive measure. I believe that the girls under 16 should seek a health practitioner for this medication so that they can be properly notified about the risks that are involved as well as the term "emergency". I believe this way, perhaps they can get the help they need, while also getting information about how to help their bodies and perhaps recieving another form of protection for the future. I also believe that perhaps the packages that are sold in stores should have information about the risks of this medication and facts about why this is called emergency contraception, and that it in no circumstance should replace normal contraceptive measures. The subpopulation under 16 who would get it through prescription will have their doctors explain these facts. So I do not believe that it would hurt to have an extra procautionary measure included in the OTC meds.