| 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 : | EC29 | ||||||||||||||||||||||
| Submitter : | Mrs. melissa sansing | Date & Time: | 09/01/2005 04:09:57 | ||||||||||||||||||||
| Organization : | Mrs. melissa sansing | ||||||||||||||||||||||
| 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? | |||||||||||||||||||||||
| Get on with it!!! You allow drugs to be sold that wind up killing people after a year or 2 on the market with no hesitation that the public can see... And no involvement from the president is seeming to be needed... this hold up is Bush/ChristianRight based from all public appearances, and they have no right to keep this from going through... Get them out of our reproductive systems and help give women the meds they need to make these very important choices before an abortion is neccessary. Are we not all trying to reduce the need for abortions or are you all just pawns in the presidents army???
Get this drug out to the public so it can do the job it has been designed to do and help keep down the number of unwanted pregnancies... from whatever conception origination... No more lame excuses, as we the public are getting so fed up with the broken promises of you and this administration... nothing is being done as we are told it will be and you make excuses... get on with it. Please and thank you. Melissa Sansing Oregon USA | |||||||||||||||||||||||
| 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, put it out for the public, who happen to be as intelligent as any of you all or the current administration... we can make this work if given the opportunity... get on with it, please! | |||||||||||||||||||||||
| B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act? | |||||||||||||||||||||||
| Is that a serious question? You all create the confusion, we see it clearly, you are dealing with your morals.. and G.W.'s... | |||||||||||||||||||||||
| C. If so, would a rulemaking on this issue help dispet that confusion? | |||||||||||||||||||||||
| another ruling... oh boy.... | |||||||||||||||||||||||
| 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? | ||||
| get on with putting this OTC... period... | ||||
| B. If it could, would it be able to do so as practical matter and, if so, how? | ||||
| You can get viagra over the internet and women have to pay out of pocket for birth control pills.... no prescription coverage, and now pharmacists are being allowed to refuse to fill the Pill Rx on moral grounds instead of doing the job they are paid to do... do any of you see there is some real conflicts against women here??????? Do any of you see them refusing to fill the RUD Rx's???????? WAKE UP and help the women who gave you all life... GET ON WITH IT!!!! PLEASE!!! | ||||
| 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? | ||||
| none of this matters... | ||||