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 : EC1156
Submitter : Mrs. Ann Murray Date & Time: 10/27/2005 04:10:46
Organization : Mrs. Ann Murray
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?
The FDA cannot in good conscience allow a drug with the same active ingredient to be both a prescription drug and an OTC drug. A change in this policy could lead to major health issues and cries of injustice and bias.
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?
If, by definition, an active drug ingredient requires a prescription, this implies some inherent safety concerns and necessitates ongoing screening by a physician. If the same ingredient is sold OTC, how then can the product be safely dispensed and momitored for possible misuse or dependency?
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
You can eliminate all confusion by stating that the same active ingredient in the same strength cannot be made availabe both by prescription and in OTC form.
C. If so, would a rulemaking on this issue help dispet that confusion?
See above
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?
There is no way in the world that the FDA could enforce this limitation. The greatest danger is that another group of individuals could obtain the drug through the legitimate population.
Some examples of this failure in our society are:
under age drinking
addictive drugs
illegal tobbaco use
All of these areas cause enforcement problems.


B. If it could, would it be able to do so as practical matter and, if so, how?
There is no practical way this can be done
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?
Absolutely not
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
It is absolutely inappropriate to sell a drug with the same active ingredient in the same strength both as a prescripition drug and as an OTC drug for all the reasons stated above.
GENERAL
GENERAL
My greatest concerns regarding the proposed policy changes involving Plan B thus allowing this drug to become an OTC is as follows:
1) inability to insure that under aged teens would not gain access to this pill and the awful social consequences of selling more young people on the lie of cheap and easy sex
2) increase of STD and other sexual health problems due to the absence of periodic physican's examination
3) long term effect of repeated use of this high dosage of birth contoll pills
4) increase of ectopic pregnancy which can be fatal
5) study from January 2004 Journal of American Medical Association which cites that Plan B does not decrease the pregnancy rate
6) future liability of FDA and degradation of trust due to abuse of this drug because it was made readily available
Thank you for your attention to this matter.
Ann Murray