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 : EC896
Submitter : Mrs. Katie Guy Date & Time: 10/17/2005 11:10:28
Organization : Mrs. Katie Guy
Category : Individual Consumer
Issue Areas/Comments
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?
If a drug has a limitation for one group of individuals and not another, being simutaneously sold as a prescription and an OTC drug will open the door for those individuals the FDA has put the limit on to easily obtain the drug illegally through a relative or friend and putting them in danger. I strongly oppose this action.
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?
This would be extremely hard to enforce by law. Any GIRL 16 years or younger can easily have a friend or relative purchase the drugh OTC for them. If, as a result of this act, the child fell ill the FDA would be responsible.
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?
This action would add even further confusion to the scenario. Having them sold in the same package would make it virtually impossible to determine if the minor child had obtained the drug lawfully, through a prescription.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
In the circumstance of the drug Plan B it would be unequivocally inappropriate to do so!!
I am adamantly opposed to the sale of 'Plan B' over the counter to anyone of any age. Your letter referres numerous times to females 16 years old and younger as 'women', I would like to emphasize that these are children, girls, not women. At the very most they are young ladies or young
women. One should be careful in his choices of words.

'Plan B' is a drug that can have serious consequences to anyone taking it. This drug should always be taken under the care of a doctor if it remains legal. Hopefully, one day soon, society will shift towards the view that drugs that cause abortions and end perfectly healthy pregnancies should be made illegal. But until then this drug needs to be strictly regulated. Liberalizing it's use will only harm women, not help them.