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 : EC155
Submitter : Ms. Diane Lamotte Date & Time: 09/20/2005 02:09:21
Organization : University of California Santa Cruz
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?
Yes, I believe a rulemaking is in order. It doesn't seem too different from a medication being OTC in one case and not being OTC when combined with something else - especially when that something else is also OTC. Note Guaifenesin - long acting vs short, with or without a decongestant. Patients ask us why these items are prescription but can be bought separately OTC when combined.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I believe that health professionals and consumers expect the FDA to make a decision. Also they expect that the FDA can make any decision - and we will of course comply, whatever it is - even if it is novel.
C. If so, would a rulemaking on this issue help dispet that confusion?
Yes, just give us the rulemakeing.
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 the FDA can enforce whatever it wants or needs to. Pharmacies currently comply with a multitude of regulations and policies. I manage a small pharmacy at a student health clinic and have no space for OTC self selection (or payment). Therefore, as a matter of policy, we pharmacists put OTC's into our Rx computer system and house them inside our pharmacy - so that the patient has to request the OTC item. We have personalized records on everyone regarding Rx and OTC medications. This is great for medication review and counseling.
Additionally, I have practiced pharmacy in 3 different states. The pharmacists comply with both federal and state regs. The state regs change from state to state and we keep the records as required - logs for needles and syringes - C-V cough medicines can be signed out in some states - whatever the ruling, we'll comply.
B. If it could, would it be able to do so as practical matter and, if so, how?
I visited Ontario, Canada and saw that they had a form to fill out and keep regarding EC. Of course, Canada already has that third class of "OTC, but limited and behind the counter", where patients must request the medication. We have a similar system in California, where pharmacists can prescribe and dispense EC. This works very well - if you have enough counseling space in your pharmacy.
Whatever you decide will be what is complied with. How about checking ID like for alcohol purchasing, or accepting implied truth of asking for the patient's birthday and believing them.
Obvoiusly, if patients over 16 years of age can get it OTC, then it will be easy to acquire and anyone old enough can get it and give it to whomever they choose.
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 think it is perfectly fine to use the same packaging. The patient will benefit from the best packaging whether they are 15 or 35. Also, the packaging is the same for C-V cough medicines that are prescription in some states but behind the counter in other states, where patients sign a special book.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Don't know of any...
It seems to me like the United States is behind the eight ball on this one. Many other developed countries have EC OTC - there is precidence elsewhere - we are not re-inventing the wheel here. I know that women have sex (what a surprise!) and either have a problem with their contraception or, the couple didn't plan ahead. The woman should not be the only responsible party here - it takes two to tango.
I help women every day avoid abortion, by providing contraception and EC. I would think that every health care provider would want to join me! I am sure you are aware of the JAMA article about access to EC that points out that promiscuity is not increased by the availability of EC. And abortion rates have been reduced since EC has been available. Our pregnancy numbers have reduced here at UC Santa Cruz when we began providing EC through the pharmacy. You can't argue with success!
Thank you for the opportunity to comment.