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 : EC353
Submitter : Dr. LOUISA VISOCKY Date & Time: 09/20/2005 04:09:13
Category : Health Professional
Issue Areas/Comments
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 makes no sense to allow a drug which is considered unsafe to use with out a physicisn's supervision ( hormones used in birth control pills) to be sold over the counter.
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?
Minors may not buy cigarettes or alcohol, yet teens under 18 manage to obtain these products by having friends buy them. Why would Plan B be any different?
If a drug at a certain dosage is considered unsafe without supervision (take naproxen as an example), it is illogical to market another drug already deemed unsafe to use at a certain dosage due to political pressure. This will not improve the safety profile of the drug. If levonorgestrol is safe enough to sell over the counter, why is Nuvaring a prescription? If the consumer is on Dilantin or Phenobarbital which have drug interactions with levonorgestrol and may lead to a pregnancy, who is going to be sued for the money to raise the child? the pharmacist dispensing? the manufacturer? Will it be adequate to put warnings on the label about high blood pressure, a bleeding or blood clotting disorder, smoking, vaginal bleeding, liver disease, migraines, diabetes, or a hormone related cancer? Or will the individual pharmacy be sued for selling an OTC product if one of these problems arises and the pharmacist had not verbally warned the purchaser? I as a pharmacist am extremely uncomfortable selling a product over the counter that already has enough warnings to deem that it requires a prescription. With the first mishap- a pregnancy or an adverse drug reaction there will be a lawsuit. Louisa Visocky Kroger Pharmacist, Fort Wayne, IN