Last week, Judge Edward Korman of the District Court of Eastern New York overturned the Obama administration's restrictions on the over-the-counter sale of the emergency contraceptive Plan B to young women under age 17. This is good news for public health, and I hope it will be the end of a long and disturbing episode in the history of US contraceptives.
Emergency contraceptives like Plan B can dramatically reduce the risk of an unintended pregnancy if taken within 72 hours after unprotected intercourse, but their efficacy wanes the longer a woman has to wait to take the drug. Making Plan B available over the counter reduces women's barriers to using it. With age restrictions in place, women 17 and older get get the drug without a prescription, but have to show identification to a pharmacist; that limits the hours and places for obtaining the drug and puts it out of reach of women without photo IDs.
Here's a summary of the FDA's actions on Plan B OTC sales, largely copied from my previous posts on this issue: In 2003, over 70 medical and public-health organizations petitioned FDA to allow unrestricted over-the-counter access to Plan B. Scientists on FDA’s scientific advisory committees and professional drug review staff strongly recommended that Plan B be granted nonprescription status, but the FDA first dragged its feet on issuing a decision and then approved nonprescription status only for those age 18 and older. In 2009, Judge Korman ruled that FDA’s determination had been based on politics rather than science, and ordered the agency both to reconsider its decision and to extend nonprescription access to 17-year-olds (which the agency did).
In 2011, Plan B manufacturer Teva Women’s Health Inc. applied to the FDA to make the drug nonprescription for “all females of childbearing potential.” In December 2011, FDA Commissioner Margaret Hamburg stated 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.” However, Secretary of Health & Human Services Kathleen Sebelius invoked her authority over FDA and required that the approval be denied -- in other words, deciding to retain the age limits for non-prescription sales of Plan B.
In his statement supporting Secretary Sebelius's decision, President Obama raised the specter of 11-year-old girls going into a drugstore and seeing emergency contraceptives alongside bubble gum and batteries. Given the approach of the 2012 elections, it was hard to view the decision as anything other than a politically motivated attempt to avoid having the President's opponents blaming him for just such an 11-year-old-girl scenario.
My colleague Susan Wood, who resigned her FDA position as assistant commissioner for women’s health in 2005 out of frustration over the Bush administration’s handling of the request to approve over-the-counter sale of emergency contraceptive Plan B, wrote about Secretary Sebelius's decision:
On its surface, the secretary’s action was a small thing. After all, invoking concerns about sexually active preteens is enough to garner the support of most parents, no matter what. But when Sebelius decided to block the FDA’s recommendation, and when she asserted her own interpretation of medical and scientific data, she set a new and potentially dangerous precedent.
While the HHS secretary does have final legal authority to make decisions for the FDA, by law these decisions must be made based on very specific and limited criteria. Political considerations are not one of them. The FDA makes recommendations based on scientific evidence to ensure that the products it approves are safe and effective. Approving or blocking medications based on political or other grounds is a slippery slope.
Imagine a future secretary appointed by a president who objects to, say, embryonic stem-cell research. Pointing to the Plan B decision, this new secretary could assert that he or she doesn’t believe the data showing effectiveness of a stem-cell-based cancer therapy and so could deny approval. Or maybe a major political contributor wants a new drug or device approved (or blocked)? The secretary–a senior political appointee, after all–could identify a “scientific” rationale to overrule the decision by the professional medical and scientific staff at the FDA.
There is a good reason why earlier secretaries have not publicly or formally overruled “controversial” FDA product-approval decisions: it doesn’t benefit the public’s health, and all of us are at risk if we cannot trust the FDA’s decisions.
There are real options for the HHS and FDA to revisit the Plan B decision and to ensure that it does not set a very risky precedent. It all starts with giving independence back to the scientists and physicians at the FDA–who, it should be noted, have recommended full approval for Plan B over the counter for nearly 10 years.
Judge Korman's latest decision doesn't erase the disturbing precedent set by Secretary Sebelius's overruling of FDA Administrator Hamburg's decision. Assuming the administration doesn't appeal the ruling -- a Justice Department statement said it's "reviewing appellate options" -- the decision will make emergency contraceptives more readily available: Judge Korman's ruling directs FDA to make Plan B and similar emergency contraceptives available without prescriptions or age restrictions, and to do so within 30 days.
In a conversation with Wonkblog's Sarah Kliff, Susan Wood expresses hope that elected officials are understanding that the public supports contraception:
Now, I think, we’re in a place where hopefully even folks in the political realm appreciate the fact that contraception is something that women and men support and don’t see as controversial. There are small elements that do, but that this is a subject that women care about because it affects their health, lives, opportunities, families and kids. All of this is really important to people.
Given the ongoing resistance to requirements for health insurance plans to cover contraceptives without co-payments, I fear that we still have a long way to go before contraception is viewed as a health issue rather than a political issue.