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 : EC1723
Submitter : Ms. Sarah Wallace Date & Time: 10/31/2005 02:10:39
Organization : Ms. Sarah Wallace
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?
The FDA should approve OTC emergency contraceptions (with no prescriptions required) and cease the political delay affecting women's health.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
It isn't apparent why the FDA is continuing with the delay other than to pander to parties with an anti-choice agenda. "Confusion" seems to be an excuse.
C. If so, would a rulemaking on this issue help dispet that confusion?
What would the rulemaking do aside from further delaying the decision on the matter? No, rulemaking would not help.