No OTC Plan B for Young Teens: The Right Call?

Sandra A. Fryhofer, MD


December 15, 2011

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Hello, I'm Dr. Sandra Fryhofer. Welcome to Medicine Matters. The topic: emergency contraception and controversy.

The Controversy

Health and Human Services (HHS) Secretary Kathleen Sebelius says Plan B One-Step® -- dubbed the "morning-after pill" -- will not be available over the counter for all females. Those 17 and above will still be able to get it without a prescription. However, for girls under age 17, a prescription will still be required.

The circumstances of that ruling are unprecedented. The manufacturer of Plan B One-Step, Teva Pharmaceutical Industries LTD, asked the FDA to remove the prescription requirement for females under age 17. The company submitted additional data showing that young girls do understand how to take the drug: 1 dose, 1 pill, taken 1 time.

Teva also submitted a study of more than 300 girls age 12-17 showing that 72%-96% understood when and why to take the medication just by reading the label. After reviewing the new data, an FDA advisory committee was unanimous in approving removing the prescription age requirement.

What came next has never happened before. HHS Secretary Kathleen Sebelius overruled the FDA. She's the secretary and it's her call. She is asking for more evidence, and in her statement she voiced concerns about "the significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age." She pointed out that 10% of girls start having periods at age 11 and questioned whether such young girls really understood what they were doing.

The White House response? President Obama says the Secretary made this decision on her own, but he agrees with it, believing it adds common sense to rule-making for over-the-counter medications. Perhaps this is not surprising for a man with 2 daughters, ages 10 and 13.

The public response? Many women's advocate groups are up in arms, as are some professional organizations. The American Congress of Obstetricians and Gynecologists, the American Academy of Pediatrics, and the Society for Adolescent Health and Medicine issued a joint statement formally denouncing this decision. Other, more conservative advocacy groups agree with the Secretary's decision.

Plan B One-Step: An Overview

What's in Plan B One-Step? Plan B One-Step is a single-tablet, single-dose emergency contraceptive (levonorgestrel, 1.5 mg). It's basically just a higher-than-normal dose of an ordinary birth control pill. To work, it must be taken within 72 hours of unprotected sex. But the sooner it's taken, the better.

How does it work? This is not an abortion pill like R-U 486. Plan B® One-Step is emergency contraception and does not end pregnancy. It works by keeping the egg from being fertilized in the first place:

  • It prevents ovulation;

  • It may prevent sperm from fertilizing the egg; and

  • It may also work by preventing implantation.

It won't work if a woman is already pregnant, and it does not disrupt an established pregnancy or harm the fetus. It does not prevent sexually transmitted diseases.

Side effects. Side effects include nausea, abdominal pain, fatigue, headache, dizziness, and heavy menstrual bleeding.

Other emergency contraceptives. Plan B One-Step is not the only emergency contraceptive available. The original Plan B, also levonorgestrel, is taken as two 0.75-mg doses 12 hours apart. A generic version, Next Choice®, is also available.

A newer emergency contraceptive, ella™ (ulipristal acetate), is a prescription-only progesterone agonist /antagonist. It is taken 1 time and has a larger window of effectiveness: It can be taken up to 5 days after intercourse.

Here Are the Facts

According to the Centers for Disease Control and Prevention, 46% of US teenagers have had sex, and nearly half a million of them give birth each year. Even though our teenage birth rates have decreased by 37% over the last 2 decades, they are still 9 times higher than those in other developed countries.

For now, given the final revised FDA decision, Plan B One-Step will remain on the market and available for all ages. However, a prescription will be still be required for girls under age 17.

One thing's for sure: All this media attention will help spread the word that emergency contraception is available and that it's effective.

So, did Secretary Sebelius make the right call?

For Medicine Matters, I'm Dr. Sandra Fryhofer.


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