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 : EC918
Submitter : Mrs. susan lyon Date & Time: 10/27/2005 08:10:40
Organization : Mrs. susan lyon
Category : Individual Consumer
Issue Areas/Comments
1
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?
no
1.
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?
no
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
no, i understand that religious forces are running this show. no confusion about that. these forces are against birth control and abortion and it is none of their business. abortion was legal and common in the us prior to the 19th century. roe v wade has made abundantly clear that it continues to be legal.
C. If so, would a rulemaking on this issue help dispet that confusion?
why don't you learn how to spell. i guess you mean"dispel," not "dispet"
2
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?
of course they would. cigarettes currently are only sold to those over the age of 18. if any cashier at a supermarket or drugstore can ask for id, for cigarettes, why not for plan b. also movies retgularly decline to admit to r rated movies those under the age of 17. why not ask them their arcane practice of figuring out who is over 17.
B. If it could, would it be able to do so as practical matter and, if so, how?
of course. show either a school id, driver's licence, or whatever. again ask the movies what they ask for in the way of id
3
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?
why not? and if not, then tell barr to package it differently. i'm sure they could do so easily and would be happy to.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
i have no idea
GENERAL
GENERAL
allow this drug to be sold otc. there are many instances when a 17 year old might be sexually active and unable to see a physician. weekends, for example. and there is the additional cost involved. why force someone to pay a fee to an md . this drug has been proved to be safe. i'm only sorry that dr. susan wood resigned rather than be party to this ridiculous finding. this is not an abortifacient in any case. it is a measure of security when a condom breaks or one has unintended sexual relations, at a party, in a car, whatever. and please allow barr to advertise this product in magazines like "seventeen"