FDA approves over-counter sale of Plan B drug for 15 and older

Published: Thursday, May 2 2013 10:55 a.m. MDT

This undated image made available by Teva Women's Health shows the packaging for their Plan B One-Step (levonorgestrel) tablet, one of the brands known as the "morning-after pill."

Associated Press

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The U.S. Food and Drug Administration will allow the "morning-after" contraceptive called Plan B One-Step to be sold without prescription to those 15 and older, lowering the age from 17. And those wanting to buy it will no longer have to ask a pharmacist. The move places it on drugstore shelves, but it will require age verification.

The Justice Department announced Wednesday that it will appeal a court ruling that would have made Plan B and Plan B One-Step available to any female of reproductive age without a prescription. The two actions, the FDA said, are independent of one another.

The government agency announced approval of Teva Women's Health Inc.'s application to market Plan B One-Step without prescription to women 15 years of age and older. There are two other emergency contraceptives that are not covered by the new FDA ruling: Plan B and Ella. Both Plan B formulas use the active ingredient levonorgestrel, but the One-Step formulation takes the two .75 mg doses taken 12 hours apart that are Plan B and combines them into one 1.5 dose.

In 2011, Health and Human Services Secretary Kathleen Sebelius blocked the FDA from approving an application by the drug manufacturer, Teva Pharmaceutical Industries, to sell the product without prescription to any female, regardless of age, according to the Wall Street Journal. The president agreed, saying he wasn't sure an 11-year-old should be able to buy medication that could have adverse effects if not used right. The agency's actions would allow the easier availability for those 15 and older, while opposing it for those younger.

According to USA Today, "The appeal, along with a request for an injunction, would not affect the Food and Drug Administration's decision Tuesday to allow the emergency contraceptive to be sold without a prescription to women and girls at least 15 years old.

"In a letter to District Judge Edward Korman of New York, the U.S. Attorney Loretta Lynch told the judge that he had exceeded his authority and that the Second Circuit Court of Appeals had been asked to suspend his April 5 ruling."

The letter repeated that the appeal and the action lowering the age at which Plan B One-Step is made available on store shelves without prescription are independent of each other.

According to the FDA, "Plan B One-Step is an emergency contraceptive intended to reduce the possibility of pregnancy following unprotected sexual intercourse — if another form of birth control (e.g., condom) was not used or failed. Plan B One-Step is a single-dose pill (1.5 mg tablet) that is most effective in decreasing the possibility of unwanted pregnancy if taken immediately or within 3 days after unprotected sexual intercourse."

If a woman is already pregnant, it won't stop the pregnancy and "there is no medical evidence that the product will harm a developing fetus," the release said.

The FDA noted the approval was based on "an actual use study and label comprehension data submitted by Teva showing that women age 15 and older understood that the product was not for routine use and would not protect them against sexually-transmitted diseases. These data also established that Plan B One-Step could be used properly within this age group without the intervention of a health care provider."

It is likely to be several months before the packaging is changed to require proof of age and to prevent theft. At that point, it will be moved from within pharmacist control to store shelves. The Journal article noted that the drug costs about $50.

Reaction has been mixed. At the time of the judge's ruling regarding Plan B, the Family Research Council's Anna Higgins told USA Today that, "Making Plan B available for girls under the age of 17 without a prescription flies in the face of medical information and sound judgment." She was concerned, she said, that over-the-counter availability would also put many at further risk of sexually transmitted diseases.

Planned Parenthood Federation of America officials released a statement praising the FDA's decision. It also asked the FDA to lift all emergency contraceptive restrictions, not just Plan B One-Step.

EMAIL: lois@desnews.com, Twitter: Loisco

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