Politics, Not Evidence Behind Plan-B Overrule

In a move clearly meant to appease social conservatives, the Obama administration took the highly unusual step yesterday of overruling the FDA’s decision to allow Plan B, the so-called “morning after pill” to be sold without a prescription for women of all ages. When I say highly unusual, I mean that such an overrule of an FDA approval has never happened before for any drug.

Dr. Robert Block, president of the American Academy of Pediatrics, called the decision “medically inexplicable,” saying that it defies strong data that shows emergency contraception is safe and effective for girls and women of all ages.

Competing statements released by Margaret Hamburg, Commisioner of the Food and Drug Administration and Kathleen Sebelius, Health and Human Services Commissioner reveal an ideological split masquerading as a concern about safety and the ability of younger teens to make an informed choice about using Plan B.

In her statement offering insight into the FDA’s decision to remove the “prescription-only” option for teens under 17, Hamburg says: “Based on the information submitted to the agency, CDER (Center for Drug Evaluation and Research) determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.” She added, “I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, 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.”

But in her statement, Sebelius said HHS felt that evidence was still lacking:

“The science has confirmed the drug to be safe and effective with appropriate use. However, the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately.” Her statement continues; “The average age of the onset of menstruation for girls in the United States is 12.4 years. However, about ten percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age. If the application were approved, the product would be available, without prescription, for all girls of reproductive age.”

Since Plan-B is available by prescription to teens younger than 17, adds Sebelius, “my decision does not change any current availability of the drug for all women.”

Sebelius is correct; the extraordinary decision to simply ignore a decade or more of safety data, FDA committee reviews and recommendations and, finally, an outright approval, doesn’t change the “current availability” of Plan B for women. It will still be available without a prescription to women who must approach the pharmacy counter, ask for it by name and provide identification proving they are 17 or over. But availability to a safe, effective, emergency method for preventing teen pregnancy, abortion and unwanted teen births remains highly inaccessible to teens younger than 17. And using the excuse that this is necessary to prevent 11 or 12-year-olds from buying Plan B is a non-starter. According to the Guttmacher Institute only 13% of teens have ever had sexual intercourse by age 15; the group doesn’t even collect data on the tiny percentage of pre-teens that might be sexually active.

In order to use Plan B One-Step, women need to take one dose of the drug within three days of having unprotected sex. The Centers for Disease Control recommends, “the sooner the pills are taken, the better they will work.” For the 14-year-old or 16-year-old who fears telling a parent about an unprotected sexual experience, obtaining a prescription may be an insurmountable barrier. There is evidence that too many teens find themselves unwilling to ask for help, with some running the risk of undergoing emotional or physical abuse were they to tell their parents that they might be pregnant, let along sexually active.

An enterprising adolescent might, on their own, be able to reach out to a trusted pediatrician or reproductive health clinic, schedule a doctor visit, actually get themselves to the appointment, ask for and receive the prescription, deal with payment for the visit and then, finally, bring the prescription to be filled at a pharmacy. All within 72 hours. But this is an enterprising teen. Those of us who actually know high school kids and are willing to acknowledge that nearly half are sexually active, are also aware that such model teens are the exception . Kids at highest risk for pregnancy are lower-income, black and Hispanic, and have parents who have attained only a high-school education or less. It’s very difficult to navigate all those barriers to accessing care. Watching a marathon of the long-running series “Sixteen and Pregnant” might be a good reality check for those who would like to keep Plan B so inaccessible to 15 and 16-year-olds.

The other point to remember is that by far, the most popular method of contraception used by 15-19 year-olds is the condom. A January 2011 Kaiser Family Foundation fact sheet finds that 80% of boys and 69% of girls said they had used a condom when they last had sexual intercourse. Remember, there is no age limit for condoms—they can be bought easily by anyone over the counter at practically every convenience store in the country and are given out free at many high schools and clinics. The CDC, in its latest report which uses data only as recent as 2008, found that 72% of women chose to use a condom as protection during their first experience of premarital intercourse. Condoms can be very effective (85-98%, according to the CDC) in preventing pregnancy as well as sexually transmitted disease. But they are by no means foolproof, especially when used incorrectly by misinformed or impaired teens who have been drinking alcohol or using drugs.

The reality is that despite a drop in the rates of both teen pregnancy and abortion in this country over the last 20 years, the KFF report found that “[t]he U.S. continues to have among the highest teen pregnancy, birth, and abortion rates in the developed world.” Here’s the shocker; American teens are having sex! And they aren’t always being careful.

Condoms—inexpensive, easily obtainable and well-promoted (think awkward banana demonstrations in sex ed classes, television advertising, promotion at concerts and sporting events, etc.) have had the biggest impact on reducing pregnancy. As Jamil Smith writes on Maddow’s Blog  , “I remember being a 16-year-old kid buying my first pack of condoms at the local drug store — less out of necessity or aspiration, and more as a social experiment to see how embarrassed I’d feel. My male privilege was inherent in my being able to do that.” Smith continues, “A girl under 17 can’t do that with Plan B. And that just hints at the manifold issues girls and women face when they seek out emergency contraception. Lack of access only engenders the notion that this is something they should be ashamed by, and decisions like [the HHS overrule] don’t help.”

The Obama administration’s record on supporting pro-choice policies, women’s reproductive rights and comprehensive sex education has been far from stellar. Yet back in 2009, Obama reiterated his support for reproductive choice and told Notre Dame graduates that it is important that we “make sure that all of our health care policies are grounded in clear ethics and sound science, as well as respect for the equality of women.” Overruling the FDA’s well-considered decision to make an over-the-counter version of Plan-B One-Step available to all women doesn’t even come close to meeting this standard.