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 : EC243
Submitter : Ms. Rachel Papeika Date & Time: 09/20/2005 02:09:03
Organization : University of Miami
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?
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?
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes, the interpretation needs to be clairfied. The FDA needs to broaded an explain what constitutes a "meaningful difference between the two products" in a quantitative way.
C. If so, would a rulemaking on this issue help dispet that confusion?
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 such a limited sale of an over the counter product to a particular subpopulation could be enforced as a matter of law so long as there are clear scientific and legal distinctions between the subpopulations constituents and the population at large as there are in this case. Younger women, under the age of 17, must in some way have a different biological, physiological, or psychological reaction to the dosage than those women who are over the age of 17. If such were not the case, then there would be no reason to restrict the sale of the drug at all. From my understanding of the scientific findings of the FDA, the drug in question, Plan B, is safe to be used as an over the counter drug for those women over the age of 17, and somehow (which was not expressly stated) not safe for over the counter use for females under the age of 17. There must be some scientific data which supports this distinction. The same scientific data can be used to legally define a subpopulation of women under the age of 17. Such a distinction
would fall under the 503(b) interpretation which will "allow marketing of the same active ingredient in products that are both prescription and OTC, assuming some meaningful difference exists between the two that makes the prescription product safe only under the supervision of a licensed practitioner." Legally speaking there is a distinction between women over the age of 18, and those below that age barrier. If the biological distinctions alone are not sufficient legally to create subpopulations, then perhaps the issue should be re-defined such that women under the age of 18 would be required to have a prescription whereas women over the age of 18 would not need one. If there is a legitimate subpopulation distinction, as is seen in this case, then legally there should not be an issue of separating the needs of the subpopulation and treating them differently according to their distinction.
B. If it could, would it be able to do so as practical matter and, if so, how?
As a practical matter, the drug could be sold simultaneously as a prescription and as an over the counter drug. Age restricted items, such as tobacco and alcohol, are sold in transactions daily, and the sale of such items is regulated by an identification confirmation made by the seller of such items. The practical enforcement of age restrictions in this matter is relatively simple. The product can be kept behind the counter at a pharmacy and when one wishes to purchase the product, one approaches the pharmacist and either shows proper identification proving that she is above the restricted age limit, or gives a prescription for the product if she is not of the age requirement. The pharmacist after confirming either age or the issued prescription then sells the product to the customer at the pharmacy. The transaction is completed at the pharmacy desk (as many prescription transactions currently are carried out across the country). The product would not exist in the conventional sense of over the counter (i.e.: such as Advil or Tylenol is) where a consumer may freely pick up the product and pay for it upon leaving the store. Instead it would be slightly more restricted by having to show proper identification. I have encountered such a practice already in existence in some pharmacies. I have found that some products in high demand, on special sale, or which are frequently shoplifted, are kept behind the counter of the pharmacy and on the "floor" of the store, is a piece of paper or coupon, on the appropriate shelf which must be brought to the pharmacy to purchase the item. The transaction takes place at the pharmacy counter with a pharmacy employee. I have also seen locked containment devices with the product inside, available on the shelves of the "floor" area. If one wishes to purchase this item, it must be taken to the pharmacy and the pharmacist unlocks the security enclosure and sells the item. While both these methods would work for the sale of Plan B, I would advocate the first because it allows for more certain control of the sale of the drug. Both these methods are legal, and work daily in large pharmacies across the country. I do not see a problem practically or legally in the selling of Plan B simultaneously as a prescription and over the counter drug.
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?
So long as there is a clear indication on the label of the package stating the product requires a prescription for those under the age of 17, and all legal warnings and usage indications are also present, I do not see a reason why the product cannot be legally sold in the same package. I am not completely familiar with the extent of packaging regulations for drugs, though I do know for biomedical devices they are very stringent. If the FDA has a code which dictates the packaging of a particular active ingredient must be somehow different if the drug is percription or over the counter, then the agency needs to deal with that specification appropriately. However in my personal experience I have noted that some drugs which once were perscription and are now over the counter (such as Claritin for example) have continued to use extremely similar, if not the same packaging now as an over the counter item as it had when it was for sale only as perscription.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
I do not expressly see a circumstance where it would be inappropriate to sell both products in the same packaging. The only circumstace where it would be inappropriate is if the age restriction deemed necessary is not enforced. However, enforcing such a age restricted regulation of sales, as expressed above, is not a difficult matter. Therefore, provided the product is sold with such age verification enforced restrictions, there is no other circumstance which in which it would be inappropriate to sell such a product in the same package as both over the counter and as a prescription.
I have the utmost respect for the FDA and the complexity of thier regulatory activities. I am certain that the agency will ultimately decide this matter and others on the basis of emperical scientific data and what action (and subsequent outcome) will hold the most benefit for consumers and the public at large.