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 : EC592
Submitter : Mr. David Ramsey Date & Time: 10/12/2005 06:10:26
Organization : Mr. David Ramsey
Category : Academia
Issue Areas/Comments
As a physician-in-training, I am extremely concerned that the Morning After Pill OTC may be used inappropriately by high risk populations, threatening both the health of the mother and child. The Hippocratic Tradition requires that patients be protected from potential harm. The minimum protection that we owe our patients is to keep these agents as prescription only.

The FDA is seeking to address a very serious and complex regulatory question regarding how to make the drug available to women 17 years and older while keeping it prescription-only for those younger. I do believe that this is a viable position.

Given the side-effect profile of these agents, and their ability to induce abortion, I believe that they should not be made OTC.

Previously, combined oral contraceptives had been determined to be carcinogenic to humans, but only primary liver cancer was specifically implicated. The WHO Working Group, after a thorough review of the published scientific evidence, concluded that combined oral contraceptives alter the risk of several common cancers in women.

Estrogen-progestogen oral contraceptives were classified in the Group 1 of carcinogenic agents. This category is used when there is sufficient evidence of carcinogenicity in humans.

These conclusions are of enormous public health importance, since it is estimated that worldwide, more than 100 million women (about 10% of all women of reproductive age) currently use combined hormonal contraceptives. In addition, there has been widespread use of hormonal menopausal therapy: approximately 20 million women in developed countries.

For all these women, the message is that the use of oral contraceptives increases the risk of breast, cervical and liver cancer. Making Morning After Pill OTC send entirely the wrong message.