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 : EC2131
Submitter : Dr. Richard Finn Date & Time: 10/31/2005 06:10:13
Organization : Dr. Richard Finn
Category : Health Professional
Issue Areas/Comments
Dear Sirs: It is my understanding that the FDA is considering the sale of Emergency Contraceptive Products (EC), Plan B, over the counter (otc) to all but those below the age of 17 years. I consider this to be a great error. First of all published studies of populations in Scotland and San Francisco showed no reduction in elective abortion among women who had EC available to them, as opposed to those who did not. In studies done in Washington State and Sweden, increased rates of sexually transmitted disease were seen in women who had otc EC available to them. And strangely in Great Britain, an ectopic pregnancy rate 3 times the normal rate was seen in women who used EC which failed. EC contains agents used in oral contraceptives. These are very powerful drugs you would be putting into the hands of 17-45 year old women who may have little idea of what serious effects these products may have or of the failure rates, etc. These should be dispensed under the guidance of professionals who can advise and follow up the women. This is not a place for self medication. Also these drugs can be administered up to 36 hours from exposure, which certainly gives the woman ample time to call her physician or Family Planning Clinic. Physicians could even prescribe the drugs in advance if they felt it was needed. But at least the woman would have a physician to turn to with questions or problems. As far as not extending otc availability to teens below age 17, I'm sure any teenager could obtain such a readily available product with little difficulty. They certainly know where to get the illegal substances quickly enough. I have little understanding of why the American College of OBGYN supports making such products so readily available. I am a member of that organization and have asked and am only given the statement to reduce unwanted pregnancy which it does not seem to do with certainty. The ACOG seems to ignore data that suggests that Plan B and products of a similar nature have potentially serious consequences. Used otc there would be innumerable errors in their administration, especially when given later than recommended. Thank You for your consideration of this email. Richard C. Finn, MD, Winston-Salem, NC