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 : EC713
Submitter : Mrs. Betty Feldman Date & Time: 10/12/2005 06:10:40
Organization : Mrs. Betty Feldman
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. The rational for not allowing a drug to be sold OTC without the supervision of a health care provider is sound and reasonable. It was in the beginning and is even more important now as newer drugs are more potent and have greater side effects, esp. those concerned with reproduction. Contraception has not decreased the # of surgical abortions, STDs, unplanned pregnancies or any other health enhancing claim made years ago; infact just the opposite has occured. There is no reason to suspect that this latest drive to push the culture further into immorality would accomplish anything but more of the same; that is an increase in surgical abortions, STDs (resulting from greater teenagr permiscuity), unplanned pregnancies, general lowering of self esteem and on and on. If you are the gaurdian of consumer well being as you claim to be you will return to the sound judgement you used in the past.
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?
See answer above
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I see no confusion in interpreting the original stand taken by FDA in the past.
C. If so, would a rulemaking on this issue help dispet that confusion?
There would be no confusion if the FDA would contiue to apply the old standard. If a drug has potentially dangerous (life threatening) side effects it should be available only through a professional who understands the pot. side effects. Unless there is overwhelming evidence as to the benefits this drug would have to the public if it became available OTC to everyone.
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 think this could and would be challenged. Who is it suppose to benefit? Young girls? They wouldn't be able to obtain it OTC as of their age.
B. If it could, would it be able to do so as practical matter and, if so, how?
See above