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 : EC2067
Submitter : Dr. Joel Rister Date & Time: 10/31/2005 06:10:04
Organization : Dr. Joel Rister
Category : Health Professional
Issue Areas/Comments
I am an Ob/Gyn in private practice and I disagree with the position taken by ACOG on this matter. The accusations of "politics" being inserted into the decision define the arguments in favor of making EC over-the-counter more than those against.
My primary concern is that I have seen no good evidence of any benefit in any study. There are many speculations on both sides of the argument that cannot be supported by any data. To "believe" the rate of unwanted pregnancies can be lowered falls short of any good reason to change current policy.
I am concerned that easy availability could lead to women avoiding any contact with a health care provider and there could be serious consequences of delayed diagnosis (ie cervical dysplasia, STDs)
I encourage you to act on the basis of the science and not be bullied into changing this policy.
Thank you,
J Mark Rister, MD