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 : EC2051
Submitter : Ms. Linda Castro Date & Time: 10/31/2005 05:10:05
Organization : US Citizen and voter
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?
Please approve this drug without further delay or meddling -- I'm sure you've gotten plenty of other emails from NOW and Planned Parenthood supporters who have been able to articulate the reasons for approval better than I can -- but I'm adding my voice to this with an uqualified -- approve the drug now.
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?
stop muddying the issue -- approve the drug -- and make pharmacists take repsonsiblity for their duty as dispensers of all legal birth control drugs --
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The Food and Drug Administration's apparent intent to limit access by age has muddled what should have been a clear- cut decision to approve over-the-counter sale of this safe and effective emergency contraception