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 : EC794
Submitter : Ms. Charle Wilson-Durr Date & Time: 10/13/2005 08:10:02
Organization : Ms. Charle Wilson-Durr
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?
It is time for the members of the FDA to make a decision to help improve access to needed medications and stop playing politics with the lives of the American people. People are only able to see the problems they cause when the problem involves them or someone of significance to them. Maybe some day soon one of the FDA members or someone important to them will face the wrath of God and will know what the common person faces day to day. Get off your behinds, do the right thing or move aside and let someone with backbone do your job.