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 : EC784
Submitter : Mrs. phrana komm Date & Time: 10/13/2005 08:10:47
Organization : food supplements distributor
Category : Individual Consumer
Issue Areas/Comments
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?
no
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?
I would hope so. There are side effects to any medicine. The younger the user, the more risk I believe. Birth control pills when issued years ago were considered very safe indeed. Years later scientific evidence has supported many women suffered blood clots, heart problems, headaches, and many other side effects. I know myself I could never take them in 1966 without extreme headaches, vomiting and so I choose other forms of birth control. I do not think this medication should be allowed except by prescription.