That promise was betrayed this past week when Health and Human Services Secretary Kathleen Sebelius overruled the FDA commissioner — and all of the physicians and scientists at the FDA — in blocking the agency’s decision to allow an emergency contraceptive to be available over the counter for all who need it.
I resigned from the FDA in 2005 after serving for five years as assistant commissioner for women’s health. I left because of my frustration that this safe and effective emergency contraceptive pill, Plan B, had been repeatedly blocked from going on sale over the counter. It was clear to me at the time that the recommendations of all the medical and scientific experts, both inside and outside the FDA, were being overruled by ideology, to the detriment of women and limiting their access to medicines.
I never understood the objection to emergency contraception. Preventing an unintended pregnancy seems like it should be common ground for those battling over reproductive rights. Yet controversy has surrounded Plan B, in part because of misinformation from those who actually oppose access to contraception.
Plan B, its newer one-pill form Plan B One-Step and the generic version, are just higher doses of the hormone found in regular birth-control pills. (They are not RU-486, the prescription medication that induces abortion.) They work primarily by blocking ovulation, through the same mechanisms found in many birth-control pills. Plan B is most effective when taken as soon as possible, so having it available easily and quickly without having to see a doctor for a prescription is key. That was the logical next step in 2003, when the company that makes Plan B first submitted an application to sell the drug over the counter. This request had the support of national physician organizations from the beginning.
It has been more than eight years since that first application, and it has been more than fiveyears since the FDA partially approved over-the-counter sales of the drug, to anyone 18 or older. In 2009, a federal court ruling forced the FDA to lower the age restriction to 17 and directed the agency to revaluate the need for any age restriction at all.
Throughout this process, the science has been solid that the drug is safe and should be available to anyone who needs it. But today — and into the future, thanks to Sebelius’s decision — though women 17 or older do not need a prescription for Plan B, it is still available only behind the pharmacy counter. As long as it is a prescription product for those younger than 17, it will have to stay there, limiting women’s urgent access to emergency contraception.
In her statement overruling the FDA’s decision, Sebelius expressed concern about the ability of young girls, 11 or 12 years old, to make serious health decisions regarding Plan B.
Yet this type of age restriction, and worries about the use of medicines by teenagers, have not been applied to other products. Apparently there is no problem in allowing younger teens to purchase products such as acetaminophen, and others with known and serious risks, over the counter. There are no age restrictions for condoms, spermicides or treatments for yeast infections, either. Indeed, for no other over-the-counter medication has the FDA ever required extra data for a particular age group. (This extra data on younger teenagers was provided to the FDA in the latest application by the company.)
But somehow, the prescription requirement for Plan B — which is very safe and impossible to overdose on — remains in place for those younger teens who are in the unfortunate situation of being at risk of pregnancy and who need emergency contraception immediately.
In discussing Sebelius’s decision, the president said that “as the father of two daughters,” he supports the secretary’s stance. I am also a parent of a younger teen daughter, and I truly empathize with Obama’s nervousness as his girls grow up. But as a parent and a scientist, I agree with the FDA that this drug is safe and effective for females of all ages. A review of the data shows that the availability of emergency contraception does not promote earlier or riskier sexual activity, but rather can prevent an unintended pregnancy if a woman — or adolescent — needs it.
When making decisions about health care, including contraception, agencies such as the FDA must be allowed to rule based on the best available information about the safety and efficacy of medical products. Decisions about whether to use emergency contraception or regular contraception (or any contraception) are best left to individuals and couples as they plan their families.
I remember watching with admiration as Obama signed the scientific integrity memo. I also remember watching his inaugural address and cheering as he said, “We will restore science to its rightful place.” I thought the FDA was back on the job and finally ready to approve Plan B for full over-the-counter status. And indeed the agency was, though it took several years.
As FDA Commissioner Margaret Hamburg stated on Wednesday: “I reviewed and thoughtfully considered the data, clinical information, and analysis provided by [the 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.”
This should have been the end of the story.
But Sebelius decided that her opinion mattered more than the conclusions of the FDA’s scientific and medical experts.
Her fig-leaf explanation that there was inadequate data on young teens just doesn’t hold water, and it is the same false rationale used years ago by those who blocked Plan B in the first place. Sebelius raises false specters of risks to young teens who might need this very safe product to prevent pregnancy, and she disregards the unified recommendations of the FDA.
In his scientific integrity memo, the president stated: “When scientific or technological information is considered in policy decisions, the information should be subject to well-established scientific processes, including peer review where appropriate, and each agency should appropriately and accurately reflect that information in complying with and applying relevant statutory standards.”
In overturning the well-considered, scientifically based decision of the FDA, Sebelius and the Department of Health and Human Services certainly did not “appropriately and accurately reflect” the available scientific information. Her precedent-setting action undermines the principles of scientific integrity and science-based policymaking — and could pave the way for a future HHS secretary to overrule the FDA in other areas.
The president should stand by the principles of scientific integrity and restore science to its rightful place. He should support the FDA commissioner and direct the secretary to allow the agency to do its job. By doing so he will fulfill the promise of that beautiful day in March 2009 when he pledged that science would trump politics, not the other way around.
Susan F. Wood is an associate professor of health policy and the director of the Jacobs Institute of Women’s Health at George Washington University. She served as assistant commissioner for women’s health at the FDA from 2000 to 2005.
Read more from Outlook, friend us on Facebook, and follow us on Twitter.