Relaxed rules on morning-after pill raise concerns

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BLOOMINGTON, Ind. (AP) — The Food and Drug Administration has decided that generic versions of the morning-after contraceptive Plan B can now be sold over the counter to girls of any age, but at least one Bloomington pharmacist says he will not sell Plan B, or a generic version of Plan B, to girls as young as 11 or 12.

"I wouldn't do that for both moral and medical reasons," said Jerry Frederick, a longtime Bloomington pharmacist. "It's not a benign drug. It contains a high level of estrogen. Would a 12-year-old girl who took this drug even know what she was taking?"

Frederick told The Herald-Times ( ) a young girl recently came into his pharmacy saying she was six weeks pregnant and wanted to terminate her pregnancy without seeing a doctor. She asked if she could end her pregnancy by buying and taking four Plan B pills.

"That would have been medically dangerous," he said. "And at $50 a pill, it would have cost her $200. If she had $200, she could afford to see a doctor."

Prior to the FDA's recent ruling, generic versions of the emergency contraceptive were restricted to those ages 17 and older, but those restrictions have now been lifted. Females of any age can now get over-the-counter generic versions of the drug, which tend to be about $10 cheaper than Plan B. The drug prevents most pregnancies if taken within 72 hours of unprotected sex for women who weigh less than 165 pounds.

Frederick is also not happy that the FDA, in June of 2013, changed its policy to allow those of any age to buy Plan B One-Step, the most popular type of emergency contraception, over the counter. The FDA said it was complying with an order two months prior from a federal judge who told the Obama administration to stop trying to impose age restrictions on over-the-counter Plan B sales.

"The courts should not be making decisions concerning drug safety," Frederick said. "The use of a drug should be the FDA's decision, not a judicial decision."

The FDA's old policy was essentially a concession to Teva Pharmaceuticals, the company that manufactures Plan B One-Step and was granted three years of exclusive rights to sell its brand name medication over the counter without an age restriction. Generic versions, meanwhile, had remained behind the pharmacy counter and were available without a prescription only to women over the age of 17, requiring an ID in order to purchase them.

Now, the FDA is saying generic versions of Plan B can come out from behind the counter, and people will be able to purchase them without showing an ID, as long as the packaging is updated to indicate that the medication is intended for women 17 years of age or older.

"We applaud the FDA's decision," said Tammy Lieber, spokeswoman for Planned Parenthood of Indiana and Kentucky. "We feel any step to increase access to emergency contraception is a positive one."

But Dave Koontz, vice president of development for Indiana Right to Life, sees things differently.

"Our concern about the morning-after pill being sold over the counter to girls of any age, whether it's Plan B or a generic, is it's a pretty powerful medication, and it's being made available to girls with no parental or medical oversight," he said.

"Having sexual activity with anyone under age 14 is considered sexual assault in Indiana and must be reported to Child Protective Services," Koontz said. "We are very concerned this ruling will make it easier for child abuse to go unreported and unnoticed."

Lieber said the Planned Parenthood center in Bloomington already sells a generic version of Plan B, called Next Choice, for $39 — about $11 less than Plan B.

"We require a prescription for it, but if someone comes here, they can get a prescription from one of our nurse practitioners and leave the same day with the drug," she said.

When asked if Planned Parenthood's nurse practitioners would write a prescription for Next Choice to an 11-year-old girl, she said that would depend on the circumstances.

"It would certainly be within the law to do that," she said. "But if our staff had reason to believe a child 13 or younger had intercourse, we are required to report that to Child Protective Services."

Lieber said if the label of a generic morning-after pill says it's "required" that it be given only to girls 17 years or older, Planned Parenthood's staff would follow that requirement. But if the label merely makes a "suggestion," the staff would evaluate each case individually.

Koontz said the morning-after pill disrupts the user's normal cycle, adding that the medical community has not fully studied its effects on young girls.

"The morning-after pill isn't like taking an aspirin," he said. "In fact, Health and Human Services Secretary Kathleen Sebelius opposed lifting age restrictions in 2011 because of a lack of studies on young girls."

Michael DeAngelis, spokesman for the CVS pharmacy's corporate office in Indianapolis, said CVS's supplier has not yet made a generic version of Plan B One-Step available, but he said CVS stores do sell Plan B One-Step for $50 over-the-counter to customers of all ages.

He said it is not sold from behind the pharmacy counter, but is sold in the store's family planning or feminine care departments.


Information from: The Herald Times,

This is an AP Member Exchange shared by The Herald-Times.

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