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FDA and Drug Maker Reach Deal on Morning-After Pill

by editor2
August 9th, 2006

Over-the-counter (OTC) sales of the Plan B emergency contraceptive in the United States could begin within a few weeks, after federal regulators and drug maker Barr Laboratories reached an agreement Monday.

Under the deal, Barr will resubmit its application for OTC sales of Plan B within two weeks and the U.S. Food and Drug Administration will act quickly on the application, The New York Times reported.

The FDA asked that the new Barr application restrict OTC sales to women 18 years of age or older. OTC sales of Plan B would be restricted to pharmacies and licensed clinics. Girls younger than 18 would need a prescription to get Plan B.

Barr Chairman Bruce Downey told The Times that acting FDA Commissioner Andrew C. von Eschenbach assured him in a phone call that the agency was committed to resolving the Plan B impasse.

The FDA has delayed a decision on OTC sales of Plan B for three years. Critics say the delay was fueled by politics, because many anti-abortion groups oppose wider availability of Plan B.

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