HHS Overrules FDA, Limiting Plan B For Teens Under 17

8:23 PM, Dec 7, 2011   |    comments
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WASHINGTON (AP) - The nation's health secretary says young teenagers cannot buy the Plan B morning-after pill without a prescription - a surprise move overruling her own experts, who were preparing to let it be sold on drugstore shelves like condoms.

The Food and Drug Administration was preparing to lift that age limit and let the emergency contraceptive be sold over the counter to anyone. But Health and Human Services Secretary Kathleen Sebelius overruled the agency, saying she was concerned that very young girls couldn't properly understand how to use it without guidance from an adult.

Teva Pharmaceuticals wanted its Plan B morning-after pill to become the first truly over-the-counter form of emergency contraception. The pill can prevent pregnancy if taken soon after unprotected sex. Currently, women 17 and older can buy it without a prescription if they show a pharmacist proof of age. Younger teens need a prescription.

Doctors' and women's health groups have long argued that the pill is safe even for younger teens and that lifting the age restriction would increase access for everyone. The nearly decade-long over-the-counter push even wound up in federal court, where a judge in 2009 ordered the Food and Drug Administration to consider lifting the age limit.
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Teva formally made that request for its Plan B One-Step in February, and the FDA's deadline to decide is Wednesday. If the FDA agrees, Plan B One-Step could be moved from behind the counter to sell on drugstore shelves. 

TUESDAY

WASHINGTON, DC (WUSA) -- The FDA may decide as soon as Wednesday to put the "morning after pill" over the counter for women of all ages.

Plan B has been mired in battles over reproductive rights for nearly a decade.

This pill can make a huge difference for rape victims, abused teenagers, or women who've just had sex without protection.
But even though it primarily works by preventing fertilization, it's also stirred the ire of groups that oppose the right to an abortion. 

"It's very safe, it's very effective," says George Washington University professor Susan Wood, who resigned from the FDA during the Bush Administration because she thought the decision-making on Plan B had become politicized. "It should go over the counter, because time is of the essence in making it work."

Taken within 72 hours of intercourse, Plan B is an estimated 85 percent effective in preventing pregnancy.

Right now, it's available to women 17 and older without a prescription -- but they still have to ask the pharmacist to go get it because teens 16 and younger need a doctor's order.
Susan Wood quit the FDA during the Bush Administration because she felt the science behind Plan B had been pushed aside by the politics of abortion rights.

"I really hope the FDA will do it's job and make a decision based on the evidence. And right not that means this product, Plan B, One Step, will go over the counter for all women," says Wood.

Opponents have a number of objections. They say Plan B can act after fertilization, and therefor is like an abortion pill. They also complain it interferes with a parents right to supervise their children, and that it subjects young women to a high dose of a potent hormone.

But Wood says the bigger risk is an unwanted teenage pregnancy. "I think it's much more life changing if a young teenager becomes pregnant."

Officially, the FDA declines to say anything about the timeline for this decision. But it has just until tomorrow to respond to the manufacturer's request to put Plan B over the counter for all women.

Written and Reported by Bruce Leshan
9News Now & wusa9.com

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