|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 :||EC824|
|Submitter :||Mrs. Helen Hund||Date & Time:||10/13/2005 10:10:13|
|Organization :||Mrs. Helen Hund|
|Category :||Individual Consumer|
| 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?|
| Dear sirs/madams,
I do not believe that "Plan B" should be marketed as an over-the-counter drug. It is dangerous to the woman and to her baby. Actually, why do you even allow the drug to be sold with a prescription? God bless the women and their babies!