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 : EC21
Submitter : Mrs. BOBBI RICHMAN Date & Time: 09/01/2005 04:09:46
Organization : NYC DOE
Category : Health Professional
Issue Areas/Comments
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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?
DEFINATELY NOT. IF IT WERE SAFE ENOUGH FOR OTC SALES IT WOULDN'T NEED TO BE PRESCRIPTION. THE PUBLIC IS NOT KNOWLEDGEABLE ENOUGH TO KNOW WHEN DR. SUPERVISION IS NECESSARY OR NOT. THERE COULD BE NO MORE CONTROL OVER WHO BUYS IT OTC THAN THERE IS FOR CIGARETTES OR LIQUOR. IF THERE IS AN AGE LIMIT, IT IS EASY TO HAVE SOMEONE ELSE PURCHASE IT FOR THE PERSON. NOT ALL STORES INFORCE THE AGE CRITERIA, NOR CAN THEY ADVISE CUSTOMERS WHETHER THEY SHOULD CONSULT A PHYSICIAN.
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B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
IT IS THE MOST POORLY WRITTEN LETTER I HAVE READ. REDUNDANT, POORLY EXPLAINED WITH NO INFORMATION ABOUT PLAN B FOR THE READER. TOTALLY CONFUSING TO UNDERSTAND THE POINT BEING MADE
C. If so, would a rulemaking on this issue help dispet that confusion?
FIRST OF ALL WHOEVER WROTE THIS QUESTION "C" SHOULD HAVE PROOF READ IT. WHAT DOES DISPET MEAN? IF YOU ARE ASKING THE PUBLICS OPINION, AND WE FEEL THERE IS CONFUSION, WHY DO YOU THINK IT WOULD BE ANY CLEARER IF YOU MAKE A DECISION YOURSELVES. WE ALL KNOW THE CORRUPTI0N IN THE FDA IN FAVOR OF MONEY MAKING DRUG COMPANIES SO WHY ASK OUR OPINION. YOU WILL DO WHAT YOU WANT ANYWAY. LOOK AT VIOX. NO MORE TO BE SAID AFTER THAT.