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 : EC448
Submitter : Mr. rishi ramkissoon Date & Time: 09/26/2005 05:09:19
Organization : PMSI Pharmacy
Category : Health Professional
Issue Areas/Comments
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?
Yes, but please be sure this is in the hands of health professionals who hold the interest of public health above politics and that they are progressive thinking to gauge needs of future generations
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes obviously there is. The real question is whether there is sufficient leeway for a manufacturer or political group to offer varying interpretations and thus affect approval/denial of a drug product. I am tempted to say that we need to be clear cut on the topic.
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?
If you make it available by prescription only then it is not considered OTC. John Public has no right to obtain it without that prescription and pharmacists can deny filling it for reasons as per any other prescription item. OTC gives the public the freedom to diagnose and treat themselves, and they will obtain it even if they think they need it and we don`t. Central to a patient`s health is autonomy. OTC meds offer this to them.
B. If it could, would it be able to do so as practical matter and, if so, how?
There is very little us as Pharmacists can do to prevent an unauthorized subpopulation from acccess for obvious reaons. ANy teen can get alcohol/tobacco if there is an adult old enough and irresponsible enough to purchase it. Pharmacists have enough on their hands to deal with between insurance adjudication, accurate dispensing, DUR, counselling and monitoring for drug diversion. Monitoring a teen as ot her age/ reproductive health and even taking responsibility for maintaining or denying access to Plan B is another burden we may not ask upon us.
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?
Yes,but then why discern between them. In fact it is quite contrary to have such a drug in both categories, unless extenuating circumstances prevail. Claritin is now OTC, prescrptions are written only for people to obtain it with a co pay as opposed to paying a full retail price
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
If it is lawful, then I guess it is not inappropriate as long as pt literature available is as comprehensive as its prescription counterpart
Plan B is a big step to a woman`s autonomy over her reproductive health. Oral Contraceptives are a drug class that affected social change in our country and the ease of ontaining Plan B is another step in the direction of those social changes. But women are not the only ones getting pregnant anymore; teen pregnancies and its impact on our healthcare system, economy are a hot topic. Are we ready for young teens, women who lack the information and resources they should have, to make a decision, especially if they are underage. Do we hold a Pharmacist responsible for a child if he/she refuses dispensing, or liable for murder by assisting.
I strongly believe that the clinics set up as saftey nets in such situations should be the source for Plan B. There is an opportunity to show women ALL options open to them and should they choose they can obtain Plan B there or maybe an Rx can be written for it.

Just a Pharmacist`s opinion=)