January 22, 2005
OTC Status of 'Morning After' Pill Again Before FDA
As reported in the Wall Street Journal (subscription required), "Fierce arguments have gone on inside and outside the Food and Drug Administration, which may decide as soon as this week whether pharmacies can sell the emergency contraceptive, known as "Plan B" -- which prevents pregnancy when taken 72 hours after unprotected sex -- without a prescription to women age 16 and older."
The drug was turned down as an over-the-counter drug last spring:
"Some staff have expressed the concern that this decision is based on nonmedical implications of teen sexual behavior, or judgments about the propriety of this activity," said the memo by the FDA's acting drug chief, Dr. Steven Galson, who last spring rejected the first application for Plan B's sale over the counter. "These issues are beyond the scope of our drug approval process, and I have not considered them in this decision."
January 22, 2005 | Permalink