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 : EC701
Submitter : Mr. Michael Sheedy Date & Time: 10/12/2005 06:10:11
Organization : Florida Catholic Conference
Category : Other Organization
Issue Areas/Comments
GENERAL
GENERAL
We offer serveral points for consideration in this regard:

1. EC can have an abortifacient effect. To make it more widely available through over-the-counter use would conflict with a trend in law and medicine which recognizes the human embryo as a human subject and a patient deserving of protection.

2. Many women are currently unaware that EC can have an abortifacient effect. This is a matter that would be of deep concern to many women were they aware of it. Over the counter use will only guarantee continued unawareness by excluding the participation of physicians who might otherwise provide this information.

3. EC carries significant risks and is contraindicated for many women. Indeed, the package insert says that EC is not to be used as a routine method of contraception. Making EC available over-the-counter would eliminate the clinical oversight necessary to ensure that EC is not used routinely. In particular, it would eliminate the clinical monitoring and follow-up needed to address the risk of ectopic pregnancy, a potentially life- threatening condition.

4. The potential for misuse of EC is especially grave in the case of minors. Over-the-counter availability for EC will make it possible for a minor to have ready access to the drugs without ever seeing a physician or notifying her parents. The Administration, if anything, should be encouraging physician involvement and parental notification, not thwarting it as this proposal, if adopted, would do. Over-the-counter access to EC may also increase risk-taking behavior and promiscuity, an especially acute problem in the case of teenagers who have higher rates of sexually transmitted disease in this country than their counterparts in other developed nations.

5. Availability of EC is not likely to significantly reduce abortions. Indeed, as we have noted, EC itself can have an abortifacient effect. Regions that have made the drugs available have not seen a reduction in abortions.

6. Over-the-counter availability of EC would likely increase the pressure already being placed on pharmacies and pharmacists to violate their conscience.

We urge the FDA not to make emergency contraceptives available over the counter.