|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 :||EC755|
|Submitter :||Ms. Selena Youmans||Date & Time:||10/13/2005 08:10:54|
|Organization :||Ms. Selena Youmans|
|Category :||Individual Consumer|
| I don't see any need for clarification of this rule in regard to marketing Plan-B as an over-the-counter medication, especially when scientific data strongly suggests that Plan-B is safe for BOTH adolescents and older women.
It seems to me that the FDA is more concerned with the political fall-out of approving the drug than with the science surrounding the decision. That is not and should not be the role of the FDA. Deciphering the will of the people is a legislative duty. The FDA should only be concerned about the safety of individual drugs without pandering to political interests.