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 : EC992
Submitter : Mr. Melvin Whang Date & Time: 10/27/2005 09:10:59
Organization : Mr. Melvin Whang
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?
Yes.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Uncertain.
C. If so, would a rulemaking on this issue help dispet that confusion?
N/A.
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?
No.
B. If it could, would it be able to do so as practical matter and, if so, how?
Uncertain.
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? Would save money, etc.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
None that I know of.
GENERAL
GENERAL
Dear Federal Drug Administration (FDA):

I am very concerned how the FDA has been handling the Emergency Contractive Pills (ECPs)and Plan B approval process for over-the- counter(OTC)use. As you and your colleages within the FDA know, ECPs are safe, studies have proven that ECPs will not increase rates of unprotected sex among adolesents. Plan B is safe and effective and an excellent public health preventive source.

I am a tax payer and would like to see FDA perform to its fullest capacity the duties for which FDA employees hired/selected are to perform. FDA nor any individual employed therein are NOT a puppets from which strings can be pulled to desuade FDA from making the right decision.

Let science and public health dictate how ECPs should be made available and let the Good Lord decide what is right and what is wrong. I ask that those staff members that are responsible within the FDA stand-up for their rights. Many individuals have resigned and/or quit their postions for what they believe in and in this case, what is scientifically correct.

I could go on, but I believe all of you responsible for the passage to allow Plan B to be available OTC know all the facts there is to know. I ask that you stand-up for what you know, believe and what you have been trained and educated to do. I also think you would agree with me, that majority of Americans detest cowards! Do your duty to your country!

I ask that you make women's health the FDA's first priority by ending the delay in approving Plan B for over-the-counter use. Help me, help our government and women to save monies, effort, time and unintended, mistimed and unwanted pregnancies.
Sincerely,
Melvin S. Y. Whang