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 : EC892
Submitter : Mr. Patrick Becker Date & Time: 10/17/2005 11:10:33
Organization : Mr. Patrick Becker
Category : Individual Consumer
Issue Areas/Comments
Sample population studies employing a policy of liberalizing the use of the plan B program did not show reduction in abortion rates. Liberalization leaves moral decision in the hands of minors who may be ill-equipped to make ethical decisions under socio-economic and libido- driven pressures. Liberalization also increases the likelihood of spreading STD because of assumed comfort with early termination of unwanted pregnacy. Further, no long term studies have been done to determine the health effects of repeated use of such powerful drugs.