Politics trumps medicine. Again.

The Obama Administration overruled the FDA recommendation on Plan B.

Today was a bad day for women’s health science. Just a few hours ago, U.S. Secretary of Health and Human Services Kathleen Sibelius invoked her authority over the Food and Drug Administration (FDA) and reversed their pending decision to remove the age-based restriction on over the counter access to emergency contraception (EC).

EC is a safe drug that can prevent a pregnancy if taken within three days of unprotected sex. Timely access is thus the most critical factor for EC to be effective.

Under the George W. Bush administration, another politicized act limited over the counter (OTC) access to EC for younger women, citing a lack of evidence that young girls could comprehend how to use the drug. To address this, a series of studies were undertaken (in which UCSF was actively involved) to see if girls as young as 11 could understand how to take two pills within 3 days of a sexual act.

Not surprisingly, the evidence found that this population, savvy with the use of technology and capable of reading at a fourth-grade level, could figure out how to use the drug safely. It should also be noted that misuse of the drug is harmless: it won’t disrupt an already established pregnancy. And other than a little nausea, there are no side effects for women using it when they don’t need to.

Based on the findings from the new studies and recognizing the body of evidence that has existed for decades, the FDA was poised to remove the age-based restriction. And then, the unthinkable happened. A presidential administration — one that ran for election on the promise of returning science to its rightful place in health care decision-making — appears to have caved to political concerns. Once again, young women’s health care needs were secondary to concerns that people would perceive this decision as approving of young people having sex.

Over the next few days, many in the reproductive health field will write about the harms that continue to be inflicted on adolescent females under age 17 who are denied OTC access to a pill that can help them prevent an unintended pregnancy and the abortion or delivery that will follow. Today, I am concerned for the integrity of the policy-making process, when even those committed to science can’t seem to stand up for their convictions.

Within the next week or so, the Obama presidential administration will need to make a decision about whether organizations that provide health care to their employees can opt out of the mandate to cover contraception as preventive health care without a co-pay. The evidence about the public health value of contraceptive health care coverage, like that for over the counter access to EC, is overwhelming. I am not optimistic that science will prevail.

Photo ©Joe Raedle/Getty Images News

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Comments
  • Molly Battistelli:

    Excellent post as always. And a very sad day for women’s health science. But not just for women’s health: this is a gloomy day for of all science. The Obama administration’s decision is one of many examples of political efforts on both sides of the aisle to ignore exhaustive and accepted scientific evidence. Today, birth control—again—rejoins AIDS, stem cells, climate change, vaccinations, abortion, energy innovation, and HIV transmission as an area in which quality research is swept under the bed in the name of political expediency. The cost of today’s decision on Plan B will eventually be quantified (thank you research!) but the cost of steady political encroachment on science and its erosive effect on our nation’s common understanding of facts regardless of interpretation will be much harder to measure.

  • Carole joffe:

    Well said, Tracy and Molly. Truly a sad day for so many of our colleagues, here and elsewhere, who continue to believe that quality research matters, and should guide public policy. Of course, mostly a sad day for those young women who simply do not have access to clinicians who can write them tehe necessary Rx in the time frame required.

    I am especially thinking today of our beloved colleague, Felicia Stewart, co founder of ANSIRH snd mentor to so many of us. One of her crowning achievements as DASPA in HHS in the Clinton years was to push for approval for EC as dedicated product. One of last professional achievements before her untimely death in 2006 was to join with allies and raise awareness of the threats to scientific integrity in the Bush years, especially with regard to repro health issues. This event would have appalled her…but I have no doubt she would tell us to keep up the struggle.

  • Darcy Baxter:

    The words of my friend’s 9 year old daughter who heard a discussion on the morning news about this decision:

    “Why are adults arguing about this? Teenagers shouldn’t have babies and probably shouldn’t have sex. But if they ARE having sex then they should be able to have the birth control pill. If they aren’t, then they don’t need it. I don’t understand why adults are arguing about this.”

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