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 : EC2066
Submitter : Ms. Debbie POSTLETHWAITE Date & Time: 10/31/2005 06:10:52
Organization : Kaiser Permanente
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?
No, there is no scientific evidence that Plan B will affect teens under 16 any differently than women > 16. Just say no campaigns have been shown to no be effective and this is based on scientific evidence. Several studies have shown that kids that take abstinence pledges are not less likely to engage in sex, they are less likely to be protected when they do. There is also no evidence that if we make EC available to all women that teens will increase sexual activity. I have been involved in making EC accessible to women since 1996 when Kaiser had the first EC kit. If EC was responsible for decreasing abortions in one year alone by 51,000 (Year 2000) how could the FDA prevent our most vulnerable from access to it. There has not been such restriction of science since Galileo's time. Why do you have scientific advisory boards if you don't use them.
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?
No
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes
C. If so, would a rulemaking on this issue help dispet that confusion?
No
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?
No, fake IDs are not that difficult to get and do you really want to criminalize a safe, effective treatment to a vulnerable population?
B. If it could, would it be able to do so as practical matter and, if so, how?
So far this is only about Plan B. Why is there a need for all these changes for this one safe, effective medication?
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
There is no need to do this at all.