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 : EC932
Submitter : Dr. Jacalyn Bitterman Date & Time: 10/27/2005 08:10:48
Organization : Dr. Jacalyn Bitterman
Category : Health Professional
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?
I am writing to voice my concern about the FDA's failure to make a decision on the application to make Plan B emergency contraception (EC) available over the counter.

Unintended pregnancy is a significant public health problem in the United States, and women deserve a chance to prevent it. Plan B is a safe, effective, and easy-to-use contraceptive option that will help reduce the need for abortion.

I urge the FDA to grant Plan B over-the-counter status for all women.
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?
I am writing to voice my concern about the FDA's failure to make a decision on the application to make Plan B emergency contraception (EC) available over the counter.

Unintended pregnancy is a significant public health problem in the United States, and women deserve a chance to prevent it. Plan B is a safe, effective, and easy-to-use contraceptive option that will help reduce the need for abortion.

I urge the FDA to grant Plan B over-the-counter status for all women.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I am writing to voice my concern about the FDA's failure to make a decision on the application to make Plan B emergency contraception (EC) available over the counter.

Unintended pregnancy is a significant public health problem in the United States, and women deserve a chance to prevent it. Plan B is a safe, effective, and easy-to-use contraceptive option that will help reduce the need for abortion.

I urge the FDA to grant Plan B over-the-counter status for all women.
C. If so, would a rulemaking on this issue help dispet that confusion?
I am writing to voice my concern about the FDA's failure to make a decision on the application to make Plan B emergency contraception (EC) available over the counter.

Unintended pregnancy is a significant public health problem in the United States, and women deserve a chance to prevent it. Plan B is a safe, effective, and easy-to-use contraceptive option that will help reduce the need for abortion.

I urge the FDA to grant Plan B over-the-counter status for all women.
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 am writing to voice my concern about the FDA's failure to make a decision on the application to make Plan B emergency contraception (EC) available over the counter.

Unintended pregnancy is a significant public health problem in the United States, and women deserve a chance to prevent it. Plan B is a safe, effective, and easy-to-use contraceptive option that will help reduce the need for abortion.

I urge the FDA to grant Plan B over-the-counter status for all women.
B. If it could, would it be able to do so as practical matter and, if so, how?
I am writing to voice my concern about the FDA's failure to make a decision on the application to make Plan B emergency contraception (EC) available over the counter.

Unintended pregnancy is a significant public health problem in the United States, and women deserve a chance to prevent it. Plan B is a safe, effective, and easy-to-use contraceptive option that will help reduce the need for abortion.

I urge the FDA to grant Plan B over-the-counter status for all women.
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 am writing to voice my concern about the FDA's failure to make a decision on the application to make Plan B emergency contraception (EC) available over the counter.

Unintended pregnancy is a significant public health problem in the United States, and women deserve a chance to prevent it. Plan B is a safe, effective, and easy-to-use contraceptive option that will help reduce the need for abortion.

I urge the FDA to grant Plan B over-the-counter status for all women.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
I am writing to voice my concern about the FDA's failure to make a decision on the application to make Plan B emergency contraception (EC) available over the counter.

Unintended pregnancy is a significant public health problem in the United States, and women deserve a chance to prevent it. Plan B is a safe, effective, and easy-to-use contraceptive option that will help reduce the need for abortion.

I urge the FDA to grant Plan B over-the-counter status for all women.
GENERAL
GENERAL
I am writing to voice my concern about the FDA's failure to make a decision on the application to make Plan B emergency contraception (EC) available over the counter.

Unintended pregnancy is a significant public health problem in the United States, and women deserve a chance to prevent it. Plan B is a safe, effective, and easy-to-use contraceptive option that will help reduce the need for abortion.

I urge the FDA to grant Plan B over-the-counter status for all women.