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FDA Has a Deal for Plan B Pill

Over-the-counter sale of the `morning-after' contraceptive hinges on adult-only access.

THE NATION

August 01, 2006|Ricardo Alonso-Zaldivar, Times Staff Writer

Von Eschenbach's letter suggested that the decision would hinge on the manufacturer's plan for keeping Plan B out of the hands of minors.

"If after our discussions we conclude that [enforcement] isn't sufficiently rigorous to prevent ... Plan B from being used by young girls who can't safely use the product without supervision," then it will remain a prescription-only drug, Von Eschenbach wrote.


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Barr Pharmaceuticals already has proposed limiting over-the-counter sales to pharmacies that agree to keep the drug behind the counter and dispensing it only after a customer shows proof of age.

But Von Eschenbach said the FDA wanted more detail, particularly on whether those restrictions would be written into a formal contract that the manufacturer would enforce.

Wendy Wright, president of Concerned Women for America, said she did not see how such a restriction could be enforced.

"The person who buys the drug is not necessarily the person who will take the drug," she said. "What the FDA would have to consider is a foolproof plan to keep proxies from buying the drug and giving it to adolescents."

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(BEGIN TEXT OF INFOBOX)

Plan B pill

Morning-after pills are considered "emergency contraception," with higher doses of the hormones present in regular birth control pills. Unlike abortion pill RU-486, morning-after pills are not intended to end an established pregnancy.

How Plan B works

First dose is taken within 72 hours of unprotected sex. Second dose is taken 12 hours later. Pregnancy may be prevented in the following ways:

1. The ovary can delay an egg's release

2. Fertilization may be prevented in the fallopian tube

3. A fertilized egg may be blocked from implanting in the uterus

4. Mucus around the cervix may become thicker and trap sperm from traveling to the fallopian tube

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Sources: Women's Capital Corp., Associated Press

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