While Secretary Sebelius’ decision to intervene and block Plan B One-Step’s OTC status was shocking on several fronts, those of us at the Center for Reproductive Rights saw it as “déjà vu all over again.”
This article is published as part of our 2012 Back Up Your Birth Control series.
The influence of politics on science and women’s health was once again on full display late last year. In December 2011, Secretary of Health and Human Services (HHS) Kathleen Sebelius blocked the U.S. Food and Drug Administration’s (FDA) approval of Plan B One-Step’s over-the-counter (OTC) status. It would have been the first time emergency contraception (EC) would be available without a prescription for women of all ages. Instead, it was the first time a HHS secretary overrode the FDA’s decision to approve a medication.
While Secretary Sebelius’ decision to intervene and block Plan B One-Step’s OTC status was shocking on several fronts—given the mounds of scientific evidence proving EC as safe and effective for adolescents and this Administration’s pledge to scientific integrity—those of us at the Center for Reproductive Rights saw it as “déjà vu all over again.”
We’ve been battling the FDA’s politicization of EC for over a decade—trying to hold the FDA accountable in federal court for treating EC differently than any other medication.
The Center initially filed a Citizen Petition with the FDA in 2001, on behalf of over 70 medical and public health organizations, asking the agency to grant OTC status to all levonorgestrel-based emergency contraception products available at the time.
Because the FDA failed to respond appropriately to both the Citizen Petition and applications from EC drug manufacturers, the Center filed a lawsuit in 2005 asserting that the FDA violated its own procedures, as well as statutory and regulatory mandates, by refusing OTC status for EC.
After the suit was filed, the FDA finally agreed to make Plan B, the leading two-pill EC brand at the time, available to women 18 and older without a prescription. But it remained behind the pharmacy counter and required government-issued identification.
By this time, it had become clear that politics was dictating the FDA’s decisions regarding EC. Four years after our lawsuit was filed, the federal court agreed and ordered the FDA to immediately grant OTC status to Plan B for women age 17 and older, and ordered the agency to reconsider the 2001 Citizen Petition.
It took another two years (and a motion for contempt) before the FDA asserted that it would resolve the issues raised by the Citizen Petition by reviewing a supplemental new drug application (SNDA) for Plan B One-Step, a one-pill EC brand submitted for OTC approval in February 2011. The SNDA sought to switch Plan B One-Step to OTC status for women of all ages. That application’s approval was blocked by Secretary Sebelius in December, even though the FDA had concluded:
“[T]here 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.”
Within a week of Secretary Sebelius’ intervention and on the eve of a hearing scheduled for the Center’s contempt motion against the FDA for once again failing to reconsider the Citizen Petition—the FDA denied the petition.
While U.S. District Judge Edward Korman found the contempt motion moot because the FDA did finally rule on the petition, he said “it seems to me that we we’re going through is a rerun of what happened before,* because once again it appears that politics is trumping science. He invited the Center to reopen our case and seek additional relief — which is exactly what we did.
On February 8, we reopened the case, adding Secretary Sebelius as a defendant and seeking immediate relief that would allow OTC access for all emergency contraceptives (both the single dose Plan B One-Step and the two-dose generic brands) for women for all ages.
Since then, Judge Korman ordered the FDA to respond to an order to show cause “why the FDA should not be directed to make Plan B available to those persons whom the studies submitted to the FDA demonstrate are capable of understanding when the use of Plan B is appropriate and the instructions for its use.” In other words, why, while the lawsuit is pending, EC should not be made available under the current behind the counter regime to younger teens. A hearing on the order to show cause has been scheduled for April 27.
While the influence of politics on science at the FDA has become increasingly blatant, the regime currently in place for accessing EC has not received the scrutiny it deserves.
OTC status is critical because the pharmacy counter itself is a barrier to access. Women 17 and older may not need a prescription for EC, but they are required to present identification to the pharmacist—posing a serious problem for low-income and minority citizens, who are less likely to possess photo identification.
And it’s not just about identification. Pharmacies may not be open late at night or on weekends, which is problematic, since the effectiveness of EC is contingent on how soon it is taken after unprotected sex or birth control failure. And a new study published in Pediatrics just this week found that nearly one in five U.S. pharmacies gave erroneous information about EC to 17 year old women, often saying that it was "impossible" for these young women to get the pill.
If EC was granted unrestricted access, it could be sold at stores other than just pharmacies and identification would not be required.
The Center will be back in court next month continuing our battle for broader access to emergency contraception. If our lawsuit is successful, women will be able to back up their birth control regardless of their age, citizenship, or where they live.
*Transcript of December 13, 2011 hearing on motion for contempt before the Honorable Edward R. Korman, E.D.N.Y., at 5.