Morning-After Pill Not Going OTC

May 07, 2004
George Anderson

By George Anderson

The Food and Drug Administration (FDA) has gone against the recommendations of its own scientific advisors by deciding to withhold approval for the over-the-counter (OTC) sale of the so-called morning-after or Plan B pill.

The FDA said in a letter to Barr Laboratories that it had made the decision based on concern about whether teenagers under the age of 16 would be able to use the pill without a doctor’s advice.

The agency didn’t completely slam the door on OTC sale of Plan B. According to an Associated Press report, Barr could possibly gain approval by supplying “data showing young teens could use the pills safely without a prescription, or providing the FDA with “details on how to make the mixed-marketing approach work.”

Moderator’s Comment: What are your thoughts on the FDA’s decision concerning Plan B?
George Anderson – Moderator

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