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 : EC1105
Submitter : Dr. peter grossman Date & Time: 10/27/2005 02:10:53
Organization : augusta ob-gyn specialist
Category : Health Professional
Issue Areas/Comments
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?
I DONT SEE WHY THE PHARMACISTS CANT CHECK ID'S AS A GRCER DOES FOR THE DISTRIBUTION ON WINE AND BEER.
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?
I DONT SEE WHY NOT. LEVONORGESTEREL HAS NO MORE POTENTIALLY TOXIC THAN TYLENOL.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
I CAN THINK OF NONE WITH REGARDS TO PLAN B
GENERAL
GENERAL
THERE IS NO JUSTIFICATION FOR LIMITING THE USE OF PLAN B AS AN OVER THE COUNTER FORMULATION. THIS MEDICATION IS APPROVED FOR USE IN OVER THIRTY COUNTRIES. lEVONORGESTEREL HAS BEEN AN ACTIVE INGREDIENT IN BIRTH CONTROL FOR YEARS AND ITS SHORT TERM USE WOULD HAVE NO UNTOWARD EFFECT ON WOMEN OF ANY REPRODUCTIVE AGE.MAKING IT AVAILABLE TO ALL WOMEN WOULD CIRCUMVENT THE "MORAL OBJECT" THAT SOME PHARMACISTS HAVE TO ITS DISTRIBUTION AS A PERSCRIPTION DRUG.
THIS IS NOT AN "ABORTION PILL" AND DOES NOT PROMOTE SEXUAL
PROMISCUITY.
IN AUGUSTA, GEORGIA WHERE I PRACTICE OBSTETRICS AND GYNECOLOGY, MANY WOMEN ARE HAVING DIFFICULY OBTAINING THIS MEDICATION BECAUSE MANY PHARMACISTS HAVE A MORAL OBJECTION BASED ON THEIR LACK OF UNDERSTANDING OF THE MEDICATION'S MECHANISM OF ACTION.
INCREASING THE AVAILABILITY OF PLAN B WILL DRASTICALLY REDUCE THE NEED FOR ABORTION IN OUR COUNTRY. ISNT THIS WHAT EVERYONE WANTS?
THANK YOU,
PETER GROSSMAN,MD