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 : EC1106
Submitter : Ms. M G Dorin Date & Time: 10/27/2005 02:10:10
Organization : none
Category : Individual Consumer
Issue Areas/Comments
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
yes
C. If so, would a rulemaking on this issue help dispet that confusion?
yes
GENERAL
GENERAL

Plan B should be approved as an over the counter drug.
Times are different today.
To think a woman could get an office visit and a script in time for Plan B to work is some what of a joke. Greedy doctors never give a script over the phone today without seeing a patient. You could be dying of the plague at home and have to go in so they can charge for an office visit.
While I think of women who have been raped, perhaps others think of it as contraception for the careless. I just know that we have too many unwanted children in our society. With Roe v Wade in crisis,
it seems we suddenly got religious. Pharmacist can now over ride the advice of a woman's physician. So.. we don't want women to have sex, we don't want them to have abortions, we don't want them to fill scripts for birth control pills or Plan B, but argue that too many women and children are on welfare.
My question is: if the FDA were comprised of all young women would this be a question at all ? What right does a bunch of men in Washinton, who will never get pregnant,have to tell single women what to do ?
As I recall when I got upset over pharmaceutical sales people bribing physicians with trinkets and lunches and whatever and called the FDA directly, one of you told me you had funding from the pharmaceutical industry, and that I, as an individual, couldn't make a difference.
So I assume it's business as usual.