I was disappointed to hear the news that Kathleen Sebelius blocked the FDA’s recommendation to make Plan B available to all girls, over-the-counter (OTC). Plan B is an oral tablet containing hormones (similar to what is in a birth control pill) that when taken within 1 to 3 days of unprotected sex, can prevent an unwanted pregnancy. It is used as a back-up birth control. Primarily, Plan B works to delay ovulation thus making it less likely that a girl could be pregnant. Effectiveness increases the earlier a girl takes the pill after unprotected sex, so we want sexually-active teens to have it on-hand, just in case.
When it comes to Plan B, timing is everything.
Girls 17 and up can get Plan B for about $50 without a prescription. They can walk into any drug store, head back to the pharmacy counter, show an ID and purchase the pill to prevent a pregnancy. Those 16 years-old and under cannot; they must see a health provider to get Plan B. Trouble is, not every girl can see the physician when they want. Many girls at risk for an unwanted pregnancy may not have access to a clinician immediately or within a day or so. Further, girls may be too embarrassed or concerned about judgment to talk with their parent. And that’s where I start to worry; an unintended pregnancy can have significant physical and emotional health consequences.
Let me be very clear: I’m all for girls seeing their pediatrician for health advice. Particularly when it comes to getting girls access to information about protecting their bodies from unwanted pregnancies, sexually transmitted diseases, and evolving sexual experiences that put them at risk. I want them in the office whenever possible to help educate, support, and guide them in making good choices. I want to help protect them.
But drawing a line between age 16 and 17 makes little sense to me, especially when timing and access to medication factors in. And when there is safety data for an at-risk population (teens).
Today, the President endorsed Ms. Sebelius’ overturning the FDA recommendation to make Plan B available over-the-counter. President Obama said:
I will say this, as the father of two daughters: I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine,
And as I understand it, the reason Kathleen made this decision was she could not be confident that a 10-year-old or an 11-year-old going into a drugstore should be able — alongside bubble gum or batteries — be able to buy a medication that potentially, if not used properly, could end up having an adverse effect. And I think most parents would probably feel the same way.
Isn’t Drano available for purchase alongside bubble gum and batteries, too?
The rationale for blocking the FDA, as I understand it, was based on concerns about a paucity of safety data on Plan B use in young girls, or 11 year-olds. Secretary Sebelius stated, “It is commonly understood that there are significant cognitive and behavioral differences between older adolescent girls and the youngest of reproductive age.” This concern informed her position on the restriction of OTC sales to girls 16 and under.
This is a politically infused issue. And I’m not interested in the politics here. Only access to equal health care for all girls.
FDA Commissioner, Dr Margaret Hamburg responded to the news of the overturn with a statement:
I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER [Center for Drug Evaluation and Research] , and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.
What do you think? Do you feel President Obama and Ms Sebelius did the right thing? Do you think this was a political move rather than a decision based in scientific fact? Do you feel girls are more at risk with Plan B over or under the counter? Read Dr Yolanda Evans’ (an adolescent medicine specialist) take on Plan B, too.