FDA Rejects Nonprescription Morning-After Pill for Now
By Lauran Neergaard The Associated Press
Published: May 6, 2004
WASHINGTON (AP) - The government rejected over-the-counter sales of morning-after birth control on Thursday because of concern about young teenagers' use of the pills. But regulators left open the possibility they will reconsider.
The Food and Drug Administration was under intense political pressure from both sides on whether to lift the prescription requirement for emergency contraception. Conservatives argued doing so could encourage unsafe sex. Proponents said easier access to the pills could prevent thousands of abortions - and the FDA's own scientific advisers had overwhelmingly backed the change.
But in a letter to Barr Laboratories late Thursday, the FDA said there was no evidence teens younger than 16 could safely use the pills without a doctor's guidance - and it thus was rejecting the move until Barr could provide that evidence.
The FDA had told Barr about the teen concern in February, and the company proposed allowing nonprescription sales for everyone 16 and older but requiring anyone younger to have a doctor's prescription.
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