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 : EC1880
Submitter : Dr. Tamara Doering Brent Date & Time: 10/31/2005 04:10:07
Organization : Washington University School of Medicine
Category : Health Professional
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?
Absolutely not, there is no precedent for this requirement and I do not believe the delay this would entail in considering current products is warranted by any data on health or safety.
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?
Absolutely not, there is no precedent for this requirement and I do not believe the delay this would entail is warranted by any data on health or safety.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I do not believe there is confusion, and rulemaking is not needed.
C. If so, would a rulemaking on this issue help dispet that confusion?
Rulemaking is not required.
GENERAL
GENERAL
I am outraged at the potential delays that have been introduced in the approval of a safe and effective product. There is precedent for packaging the same compound for prescription and non-prescription use, and the delay caused by rulemaking will cause numerous women to undergo distress and countless needless abortions to occur. This rulemaking delay is being introduced counter to all scientific and health data. This process must be stopped and the recommendations of government reviewers must be taken seriously, with the approval of drugs as appropriate. Approval of one compound must not be linked to this process.