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 : EC884
Submitter : Dr. C Eric Lindborg Date & Time: 10/17/2005 11:10:09
Organization : Dr. C Eric Lindborg
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?
N/A
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?
Do not foresee that FDA would be able to meaningfully enforce.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
None
GENERAL
GENERAL
I see this as a safe medication for which there is public good accruing by increasing access to the general public.

I do not agree with the age limitation. Labels on the box or in patient education material can review risks of inappropriate usage. Practically speaking the product would be purchased only by or on behalf of individuals who are at risk of unwanted pregnancy. Any measures that decrease the likelihood of unwanted pregnancy serve the best interests of the individual affected as well as society at large. As a physician I have seen too many women having to deal with the hard realities of seeking abortion, coping with the challenges of providing for an unwanted child, or working through the complex decision to give a child up for adoption.

The medication will not be abuse and provides real benefits at any level of analysis.

Please proceed to allow OTC availability