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 : EC866
Submitter : Ms. Marya DeBlasi Date & Time: 10/17/2005 10:10:34
Organization : Ms. Marya DeBlasi
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?

Section 503b of what. You're own internal advisory committee agreed that Plan B be marked as an over the counter emergency contraceptive.





1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There must, be since I don't even know what section 503b is. It seems to be a matter of obfuscation, since anyone trying to make a comment during the public comment period, about plan B, could not know which docket referred to it. Fortunately I was tenacious enough to send a letter to a general comments mail box. Having been sent here I am faced w/ questions not about Plan B, but 503b.
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?
Why would one want to do this. Are you suggesting that there would be a problem w/ Plan be being OTC while regular birth control pills are prescription only? There is plenty of precedent for this. So many times have I gone to the pharmacy w/ a prescription only to be told that my insurance will not pay for it because there was a lower dose available over the counter.
B. If it could, would it be able to do so as practical matter and, if so, how?
see above
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?
Are you intentionally being vague. The first half of this question establishes that we are talking about 2 dosages of the same medicine, the second half asks about "different products." By the same package do you mean a Plan B pill inside my box of Ortho-novum 777? I thought not. These items will be marketed by profit making industries; I am sure they will go out of their way to differentiate them.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Why would you sell them in a single package? If one wants a morning after pill it is unlikely that she was using the pill. If she was on the pill and realized that she may have jeopardised herself by missing a dose she should be able to go to the drug store & get 1 dose of Plan B, with out causing a public fuss
GENERAL
GENERAL
Dear FDA

I would like to express my opinion about Plan B emergency contraceptive,
while the comment period is open.

You have gone against the advice of your own advisory committee in failing
to approve Plan B. The reason for this can only be Religious and
Political.
Neither are good reasons to interfere in the private life of citizens.

As you may well know, and in spite of what the Fundamentalist christians
are
saying, we are not discussing the "killing of embryos" the bodies under
scrutiny are blastula. Two layers of undifferentiated cells surrounding
an
open center. You also must know the percentage of blastula which fail to
implant in the uterine wall, some have suggested that up to 80% are
passed
in the next menstrual period, or are reabsorbed.

Finally, I must point out that Americans are already going to Canada for
their prescriptions in alarming numbers, what you are doing is encouraging
a
black market in Plan B, passed from woman to woman, so that we do not have
to undergo abortion or unwanted pregnancy.

Please reconsider you decision on Plan B, before any more of your
dedicated
career public health care workers resign leaving you bereft of any but
political appointees and lackeys