The Obama administration yesterday dropped its appeal of a judge’s order to follow the science and allow consumers full over the counter access to the emergency contraception known as Plan B. I never thought I’ve be invoking Kenny Rogers in a blog post, but somehow it now seems to fit: you gotta know when to hold ’em. Know when to fold ’em.The Obama administration should have folded long ago; for reasons unknown, it chose to stay in the game. In the process, it earned a serious black eye.
I started working on this issue in 2005 when Dr. Susan Wood, then head of the FDA’s Office of Women’s Health, resigned in protest over the Bush administration’s decision to overrule the scientific determinations of FDA staff and an independent advisory committee. The issue has had enough twists and turns to make your head spin.
It is sad how many thousands of hours and millions of dollars were spent over the past decade trying to get this decision right. It is sad how many unintended pregnancies and abortions could have been prevented had the FDA been allowed to do its job and make a science-based decision. And it is sad that both a Republican president and a Democratic president lacked the political will to disregard those who chose to misrepresent the science behind emergency contraception.
The Center for Reproductive Rights has a nice timeline of events through April 2012, which I won’t repeat. Here’s what’s happened since that date:
November 26, 2012: The American Academy of Pediatrics recommends that doctors preemptively give Plan B prescriptions to teens to overcome the unnecessary access barriers.
December 2012: The American Congress of Obstetricians and Gynecologists states its support of over-the-counter access.
December 7, 2012: UCS joins public health and other scientific organizations on a letter to Health and Human Services Secretary Sebelius in urging the administration to revisit its decision.
April 7, 2013: Federal Judge Edward Korman orders the Food and Drug Administration (FDA) to make “Plan B” emergency contraception available to women of all ages without a prescription, calling efforts to stop the FDA from doing so “arbitrary, capricious, and unreasonable.”
April 30, 2013: The FDA fails to comply with the judge’s order, announcing it will approve sales for women fifteen years and older for sale on store shelves.
May 1, 2013: The Department of Justice appeals Judge Kornan’s ruling and requested that the ruling be suspended until the appeals court hears the case.
May 7, 2013: Judge Kornan hears oral arguments regarding the administration’s appeal and stay request, using the opportunity to rip into the administration’s flimsy arguments.
May 11, 2013: Judge Kornan refuses the administration’s request for a stay. The Obama administration subsequently asks the appeals court to delay implementation of Judge Kornan’s ruling.
June 5, 2013: The appeals court rules that the two-pill generic version of the drug should be available to women of all ages over the counter while the court considers the administration’s appeal of the one-pill brand name version.
June 10, 2013: The administration announces that it will drop its appeal and outlines plans to promptly approve the drug for over the counter sales.
It’s still possible, of course, that the administration will drag its feet when it comes to implementing the FDA’s decision to allow over the counter access to Plan B. And there may be unexpected hurdles that we haven’t even thought of.
But hopefully, we can now turn our attention to other problems that the Obama administration has with scientific integrity–such as the White House’s tendency to hold up science-based public protections it doesn’t like.
Posted in: Scientific Integrity
Tags: Scientific Integrity, HHS, prescription drugs, Plan B, political interference in science, White House, President Obama, emergency contraception, Kathleen Sebelius
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