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 : EC1974
Submitter : Mrs. Meryl Motika Date & Time: 10/31/2005 04:10:33
Organization : Mrs. Meryl Motika
Category : Individual Consumer
Issue Areas/Comments
B. If it could, would it be able to do so as practical matter and, if so, how?
Absolutely. Pharmacists would simply need to record that they had checked a patient's ID and that the patient was over 16. Pharmacies already have age requirements for nicotine products. There is no reason in the world they wouldn't be able to handle one for birth control.
It is vital to public health that Plan B be made more widely available. Studies have shown convincingly that having it over-the-counter would enormously reduce unwanted pregnancies and abortions, without encouraging unsafe sex. Given the facts, it is the FDA's duty to find a way to make it available to women without a prescription, not to ache over irrelevant regulations. The FDA has been shockingly sluggish about approving Plan B for over-the-counter use thus far. It's time to move forward.