post by Paul Kelleher
As someone who has published a scholarly article on the ethics of Plan B, I feel as if I should have something interesting to say about Secretary Sebelius's decision this week to overrule the FDA Commissioner's and Staff's recommendation to make an emergency contraceptive pill purchasable without a prescription by individuals younger than 17. My general thoughts pretty much echo Jon Cohn's nice piece on the decision; the ongoing coverage and commentary at the RH Reality Check blog is also very good. These writings express dismay and disappointment over Sebelius's decision, and decry it as the sort of politics-over-science policy making that appears in conflict with a 2009 executive order on the subject issued by President Obama.
I don't think we should be surprised that politics won out here, even in an Obama administration. Can anyone say with confidence that the President's reelection campaign wouldn't have been significantly damaged by a concerted Republican attack on this decision? If a Medicare proposal to reimburse for a doctor-patient conversation about advanced care directives can become "death panels," surely over-the-counter status of Plan B could be turned into Obama's "abortion pill for little girls" decision. Never mind that there is no evidence whatsoever that Plan B affects an established pregnancy or that it impedes implantation of an already fertilized egg (and so is absolutely not an abortion pill). Never mind that "the best available evidence is that the ability of levonorgestrel and ulipristal acetate ECPs to prevent pregnancy can be fully accounted for by mechanisms that do not involve interference with post‐fertilization events." When the Washington Times ran an editorial about comparative effectiveness research provisions in the Affordable Care Act, it did not rely on facts in deciding to run a picture of Hitler along side it. (The paper has since removed the picture from its website, but I saved it here for posterity.)
Sebelius's decision--is there reason not to call it Obama's decision?--has two key implications. First, ready access to Plan B is important because Plan B's effectiveness drops 50% after the first 12 hours following unprotected sex (or sex with a contraceptive that failed). (Indeed, the existence of this small window is one key reason why scientists believe Plan B probably does not prevent implantation after an egg has been fertilized.) So young women and girls who have sexual intercourse late on a Saturday night may find themselves unable to access the drug in time for it to work anywhere near peak effectiveness (although it is labeled as still reducing the risk of pregnancy when taken up to 72 hours after). Second, Plan B will continue to be sold behind the counter to women 17 and older. This means that these women, who are legally allowed to buy it without a prescription, still must ask a pharmacist for the product, rather than tossing it in their shopping cart along other random products to distract from the purchase. Many women will be reluctant to approach a pharmacist to ask vocally for Plan B, either because they are for some reason shy or embarrassed about it, or because they fear the pharmacist will judge them or, worse, "conscientiously refuse" to dispense it to them (this was the subject of my article).
There is one other element in this story that I find curiously downplayed, and that is the awkward gatekeeper role that physicians will continue to play for young women under 17. Sebelius's decision means that girls 16 and younger will need a prescription to purchase Plan B. Any physician who writes prescriptions should be well-versed in the medical literature about the drug. But this just means that physicians will read everything that the FDA read, which apparently included study data about Plan B's safety for girls as young as 11. This was, moreover, precisely the evidence that Sebelius and Obama explicitly disregarded in their public comments on the administration's effective veto. So the Obama administration is effectively asking physicians to consider medical evidence that the administration itself implied did not exist.
But now suppose that a physician has read up on the literature and believes Plan B is safe for young women and girls under the age of 17. Under what circumstances will such a physician prescribe Plan B to a patient requesting it? Well, given that the physician knows that Plan B's effectiveness drops precipitously in the hours after intercourse, one assumes that most physicians who write prescriptions for Plan B will do so over the phone, without an office visit. Virtually no one supposes the physician will request an examination to ensure that the patient is telling the truth about what induced her to contact the doc in the first place.
In the end, leaving physicians in the mix is quite unlikely to protect or promote the patient's medical interests. Rather, it will more often simply lead to some patients' experiencing a fateful delay in access to Plan B, while other patients may be forced to fill their parents in as a means or side-effect of involving the physician. But the need for parental involvement was, so far as I know, not cited by the Obama administration as a reason for its decision. And what training do physicians have in deciding whether a 16 year old's parents must be or should be informed about their daughter's predicament in such situations?
For all these reasons many such doctors may well prefer that these decisions be made at a societal level, in light of all available evidence and moral argument. But instead, doctors will continue to occupy an awkward gatekeeper role whose existence will almost certainly lead to a higher incidence of teenage pregnancy among their patients than would have been the case if the Obama administration had heeded the advice of the FDA. It really is hard to see anything but political calculation in this decision.