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 : EC839
Submitter : Dr. Laura Jago Date & Time: 10/13/2005 10:10:44
Organization : CVS Pharmacy
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?
As been the process for a long time, the FDA has a statute that an active ingredient may not be simultaneously marketed in both prescription and OTC drug product. This should stand as is, and not be modified just for this one product. FDA makes these regulations for sound reason and should not be overturned just because a case arises with political interests. I am a pharmacist and what I do is guided by, and I rely on, these statutes. The FDS should stick by its regulations, which have worked so well over time. It would be confusing to have a drug both marketed as prescriptions only and over the counter, especially when there is no difference in the drug or packaging.
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?
Again, a single active ingredient should not be marketed both as prescription only and over the counter. FDA should stick by their policy which has been in place for many years, without prior incident. They should not make an exception or worse, initiate rulemaking to change this.
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. there would have to be extensive regulations as to its access. many pharmacists are crunched for time as is. see below.
B. If it could, would it be able to do so as practical matter and, if so, how?
It might prove difficult to determine who is eligible to receive the OTC item versus the Rx item-ie, how can we be sure that the person intending consumption falls over the age of 16 or 17? In this case, pharmacists would have to control the sale, maybe including the OTC product behing the counter although still OTC. We would have to ask for identification, which may prove difficult if the person does not have a drivers license yet (age 16 or 17 may not have one yet). Another issue is that many pharmacist currently have the option NOT to dispense emergency contraception (the case in Maryland),due to relgious beliefs. These pharmacist would also carry this into the process of selling the item OTC. Pharmacists who currently object to dispensing the prescription Plan B would also object to dispensing this item OTC. Taking away that right to object by allowing OTC sale would forfeit the current right to object which has been ruled on, and allowed as long as the Rph refers the patient to another pharmacy who is willing to fill the prescription. Personally, as an Rph with CVS practicing in MD, I was given the opportunity to object to
dispensing/filling prescription Plan B, which I enthusiastically took. Allowing this product to go OTC would obliverate this right of mine to refuse to dispense, since I object to its use in those over the age of 17 as well.
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?
Allowing this product to be available OTC, even to a limited population (ie, those over age 17) would be horrific. Having this product OTC would promote unsafe sexual activity overall, increasing the cases of sexually transmitted diseases. When a child/adolescent knows that there is a quick, easy and widely available way to "repair" their situation, they will not take the precautions that they will wihtout this method being so widely available. There is already significant morbidity and mortality associated with STDs. We as a nation are fighting hard and spending billions of dollars on a cure for AIDS, and this move from Rx to OTC will only make the AIDS epidemic worse. When there are no reprocusions for actions, they will engage in these actions-when a patient knows there is a product over the counter to prevent pregnancy right after she engages in unprotected sex, she will. Having this product avaialble OTC will only increase unsafe behavior, and decrease personal responsibility for ones actions (unsafe sex). Yes, studies that have shown evidence to the contrary, but they have been short term in nature, with only a few months to a year in follow up and not powered sufficently. People will see they do not have to take the full responsibility for their actions, and will be less careful with sex knowing there is a security blanket. This means those who use the product will use it repeatedly, which is not its inteded use. Over time having this product available OTC will inevitably lead to increased (unlabeled) use, misconduct and unsafe sexual practices increasing sexually transmitted disease and morbity and mortality.