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 : EC734
Submitter : Mr. gerald hackert Date & Time: 10/13/2005 08:10:36
Organization : Mr. gerald hackert
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?
NO to the morning after pill. Studies show when this is available women think they have a safe solution to keeping from becoming pg. and the result is increased sexual promiscuity, and an undesirable increase in STDs. This mdeication only encourages the sexual behavior none of us want for our sons or daughters.
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?
never, never OTC.
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?
The FDA has no enforcement orginazation or ability.