FDA to Increase Access to Generic Version of Morning-After Pill

First Posted: Mar 02, 2014 06:05 PM EST
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The Food and Drug Administration (FDA) approved the sale of a generic and cheaper form of the morning-after contraceptive Plan B without age restrictions.

Versions of the emergency contraceptive had been restricted to women ages 17 and older, yet those restrictions now have been lifted, according to Time--allowing those of any age to purchase the original Plan B and generic versions of the drug. For women who weigh less than 165 pounds, taking either will likely result in the termination of a pregnancy if unprotected sex occurred within a 72-hour-period.

The news organization notes that Plan B's original maker, Teva Pharmaceuticals, is the only drug that works to produce and sell the morning-after pill over the counter without age requirements. Other pills have a 17 and up age restriction requirement.

Yet in an 11-page letter to the generic competitors that was sent earlier this week, Kathleen Uhl, acting director of the FDA's Office of Generic Drugs, notes of Teva's concern that selling these products over the counter minus age restrictions may be "too broad," according to NPR.

Now, the FDA notes that the generic versions must say on the labels that they are intended for "women 17 years of age or older." However, they will be available on shelves without an age requirement to purchase.

"This is a significant leap forward in obtaining full, over-the-counter status for emergency contraception and we commend the FDA for this decision," said Jessica Arons, president and CEO of the Reproductive Health Technologies Project, via the news organizaiton. "Everyone deserves a second chance to get it right, including the FDA."

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