Plan B: where politics trump science. Again.

By Amanda Marcotte
December 8, 2011

By Amanda Marcotte
The views expressed are her own.

Wednesday morning Health and Human Services Secretary Kathleen Sebelius overruled the FDA’s long-awaited decision taking age restrictions off Plan B emergency contraception. The change would have allowed those 16 and under to buy Plan B, moving it from behind the pharmacist counter and into the shelves alongside aspirin and condoms. But now that won’t happen.

The decision confounded the medical community as well as the women’s rights world. Since no HHS Secretary has ever overruled an FDA decision of this sort before, the widespread assumption, best articulated by Matt Langer at Wonkette, was that Sebelius was working under “marching orders from an administration now fully in re-election mode” and fearful of getting a reputation as somehow “soft” on teen sexual activity.

Sebelius admitted to no political calculation, and instead claimed to be concerned about supposedly inadequate research into the effects on 11- and 12-year-olds who might use the pill. FDA Commissioner Margaret Hamburg, no doubt irate at being told she and her entire team don’t know how to do their job as well as non-medical professional Sebelius, denounced this argument, and defended the extensive research done to assure that Plan B was safe for over-the-counter sales. Taking into account the evidence, and the drawn-out political battle over emergency contraception, it’s safe to say that Sebelius did choose political pandering over women and girls’ best interests.

Sebelius was remarkably vague with her concerns about the differences between those under and over 16 years old when it comes to using Plan B. There’s no reason to believe even the youngest girls who access the drug are in any physical danger, which is why groups like the American Academy of Pediatrics support its use for their young patients in need. Emergency contraception is simply a single, high dose of the birth control pill, a drug that girls in the first years of reproductive age (and women far older than them) have been using for decades on a daily basis for contraception and other health reasons. (One formulation of the daily version of the pill, Ortho Tri Cyclen, is even marketed directly to teenagers to control acne.) The most serious common side effect of correctly-taken Plan B is nausea which tends to last for a few hours. (As opposed to the months of nausea that come along with pregnancy.)

The lack of evidence of physical danger to young teenagers taking the pill correctly meant Sebelius was left with mealy-mouthed claims that the dangers to young teenagers were due to the unique inability of girls 11 to 16 to understand the instructions and take the pill properly. She claimed that “there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age,” and then provided no evidence to support the contention that girls 11 to 16 cannot be expected to take the pill correctly.

This claim defies common sense as well as scientific research. Plan B is expensive enough–$35 to $50–that it prevents young women from using it multiple times a month. And it’s a single dose pill. It’s easier to incorrectly take Advil. What else does Sebelius want, a chewable? But in case common sense doesn’t do it for you, the research compiled by the FDA should. Two studies, which FDA Commissioner Hamburg described as “designed specifically to address the regulatory standards for nonprescription drugs”, one involving girls 12 to 17 and one involving girls 11 to 16, showed that they teenagers understood the package well enough to take the medication without a doctor’s supervision.

Teva Pharmaceuticals, the Israeli manufacturer of Plan B, met every standard the FDA uses to evaluate whether or not a drug should be sold over-the-counter with no age restrictions, and they met the standards years ago. In 2005, Bush administration officials also hijacked the over-the-counter approval process, citing vague concerns about the decision-making skills of the under-18 set. The Government Accountability Office excoriated the politicized process that kept Plan B behind the pharmacist counter, noting that out of the 67 proposed prescription-to-OTC switches considered from 1994 to 2004, Plan B was the only one whose application was denied despite the advisory committee’s recommendation for approval.

In other words, we’re seeing a pattern.

1.)   Teva applies to sell Plan B over the counter.

2.)   The medical experts weigh the evidence and agree with their application.

3.)   But political appointees with ties to the White House block the switch, citing vague concerns about the decision-making abilities of teenagers.

No one wants 11-year-olds to have sex, of course, but that concern shouldn’t play a role in this. In a press release addressing Sebelius’s decision, the Guttmacher Institute, a nonpartisan research institute that studies sexual health, noted that fewer than 1 percent of 11-year-olds are sexually active, but almost half of teenage girls are having sex by age 17. There’s no evidence to suggest that making Plan B available to all teenagers will somehow push younger teenagers to start having sex in greater numbers. If Sebelius actually had concerns about the effect of this drug on the behavior of younger teenagers, she could have looked to Canada, where Plan B is sold over the counter without age restrictions, with no discernible outbreaks of promiscuity in junior high school. Meanwhile, the United States still has a teen birth rate three times that of Canada’s, which easy access to Plan B could help curb.

Over the past decade, more than 70 medical organizations, the bulk of the FDA’s review committees, the Union of Concerned Scientists, and the Center for Drug Evaluation and Research have all endorsed selling Plan B over the counter with no age restrictions. The only person left standing against the switch is a career politician with a background of lobbying on the behalf of trial lawyers, whose job depends on her boss getting re-elected. Sebelius’s claim that she’s standing up for better science instead of pandering to American fears about teenage sexuality sounds hollow. As hollow as all those Republicans who flaunt the experts to deny climate change.

Photo: U.S. President Barack Obama speaks before signing an executive order directing the Food and Drug Administration (FDA) to take action to help further prevent and reduce prescription drug shortages, protect consumers and prevent price gouging in the Oval Office of the White House in Washington October 31, 2011. Standing behind Obama is Secretary of Health and Human Services Kathleen Sebelius. REUTERS/Kevin Lamarque


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