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 : EC1025
Submitter : Ms. Allison Weaver Date & Time: 10/27/2005 10:10:24
Organization : Association of American Indian Physicians
Category : Health Care Association
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?
YES! my God, you all are trying in every way now to control women's bodies!! it takes TWO to make a baby - though the DECISION regarding birth lies inside a woman. This drug is safe, effective and allows that abortion not be necessary as she plans her life and the life of those she is prepared to bring into this world!!
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?
YES! my God, you all are trying in every way now to control women's bodies!! it takes TWO to make a baby - though the DECISION regarding birth lies inside a woman. This drug is safe, effective and allows that abortion not be necessary as she plans her life and the life of those she is prepared to bring into this world!!
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
bunch of empty, unscienced bush idiot appointee's - look what happened when the abilities of his FEMA head came to the test of efficacy.
C. If so, would a rulemaking on this issue help dispet that confusion?
yup
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?
that's ridiculas - the pill is not prescription, it's the same biology.
B. If it could, would it be able to do so as practical matter and, if so, how?
control freaks in an area most private.