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 : EC914
Submitter : Dr. Kathryn Johnson Date & Time: 10/18/2005 01:10:19
Organization : Dr. Kathryn Johnson
Category : Health Professional
Issue Areas/Comments
To whom it may concern:
I would like to comment specifically on the proposed OTC sale of the morning after pill. It is my strong belief that in making such products available without a prescription, we do a tremendous disservice to would-be-users. In making any medication available without a prescription, we rely on the good judgment of patients to use the agent for appropriate indications and as directed. The population of women who would be targeted to use this drug are much more likely than the average population to be in an emotionally or personally compromised situation that might lead to impaired judgment. Hormonal agents, including oral contraceptives and hormone replacement therapy, have many potentially serious side effects, including increased risk or breast cancer and thromboembolic disease to name only two. The morning after pill most certainly carries similar risks. I do not think we do patients/ consumers a favor by making it available without doctor supervision. Moreover, OTC availability is unnecessary as many women's health clinics are more than willing to hand it out to anyone who asks.
In addition to these practical objections, several moral issues come into play as well. First and foremost, as physicians and health care practitioners, our mantra is to be 'first do no harm.' While harm done to the mother is one issue, harm done to the child conceived cannot be ignored. If it cannot be proven with certainty that a person is not a person from the very moment of conception, then we must err on the side of life, and act in accord with the dignity owed every human being from the moment of their conception.
Thank you for your consideration,
Kathryn Johnson, MD