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 : EC216
Submitter : Dr. pamela ellis Date & Time: 09/20/2005 02:09:57
Organization : Gainesville Area National Organization for Women
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?
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?
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. Similarly to the current requirement of the statement 'Federal law requires prescription for this medication' be printed on the Rx version and not on the OTC version. Although, psuedoephedrine has recently been restricted to 18 and over and behind-the-counter status and it underwent no package change whatsoever. Who is enforcing this limitation? This stall tactic is ridiculous in light of the fact that these situations already exist in todays market.
B. If it could, would it be able to do so as practical matter and, if so, how?
Yes. State Departments of Health will inspect the process as it does all other processes. ID's will be checked for OTC product as with nicotine patches, alcohol, cigarettes, etc...However, let me be clear and say that Plan B should be available OTC with NO age restriction. A bottle of Tylenol, which can be purchased by anyone, poses a far greater health threat if used incorrectly than Plan B ever would.
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?
It is legal. For example, I currently have OTC Prilosec in my pharmacy AND a prescription-only omeprazole. Therefore, Plan B would require different packaging on the outside stating its Rx requirement for Rx version and not for the behind-the-counter version. The inside packaging would remain the same as 15 year-olds will take it the same way as 30 year-olds will. This is no reason for a delay to market. Incidently, pseudoephedrine products were just put behind-the-counter, at least in my state, with NO change in packaging. Perhaps if pregnancy affected everyone as does nasal congestion, years of delay and request for public comment would not be necessary.
Plan B is safe for use by women of ALL ages. It has been available OTC in over 38 other countries for years. The data is available on use in teenagers and adults and should have been consulted at the time of application. Withholding this incredibly effective and safe drug, the 2 requirements for OTC status, the FDA is doing a disservice to women and women's healthcare and destroying its reputation as a sound, scientific entity on which the American public can depend. It should be clear to all, regardless of beliefs or values, that the effects of taking Plan B is infinintely less damaging to the body than a pregnancy is. Especially when a 13 year-old is carrying to full term. When will women stopped being punished for their biology? Women must have all the options possible to control their reproduction. This product is one of the best to come along in some time. Stop bowing to right-wing political pressure and do the job the FDA was commissioned to do! Be scientists and let individuals decide their morality.