Recently, the Irish state’s national Medicines Board legalized the availability of emergency contraception on an over-the-counter basis in high-street pharmacies. The drug, NorLevo, an emergency contraception that can prevent pregnancy if taken within 72 hours after unprotected sexual intercourse, is now available to all women without the requirement that they first obtain a prescription. Essentially, the move came as the result of a combination of failed regulation and market forces. For the previous month, the major pharmacy chain Boots had decided — in apparent contradiction of the existing regulations — to go ahead anyway and sell the so-called “morning-after pill” to women without requiring them to first supply a prescription. Boots justified their decision by formulating a “new” legalistic interpretation of the existing regulations (despite the fact that the spirit of these regulations was clearly intended to prevent such availability).
The pharmacy experienced huge demand from its customers, and charging around €40 (c. $55) per pill, began to identify huge profits for itself. Only after the Irish Medicines Board sought to clamp down on what was purportedly the illegal sale of controlled drugs in high-street pharmacies, did HRA Pharma (the manufacturers of NorLevo) submit a formal application to the Board asking it to alter the prescription-only status of their product. Despite the fact that a similar application had foundered in 2007, on this occasion (and with a major retailer having demonstrated such steady consumer demand) the Board approved the change within weeks. Thus, on 16 February 2011, two days after St Valentine’s day, emergency contraception became available for high-street retail to Irish women on a no-questions-asked basis.
(One strange outcome of this rather stilted introduction process is that the morning-after pill is now available to women of all ages in Ireland. Internationally, it is more typical for some age restrictions to be applied, in order to ensure that particularly young women and girls engaged in unprotected sex are required to present themselves to a primary care physician.)
That this system has been introduced relatively smoothly, with only minor after-the-fact complaints in the Irish media, contrasts sharply with introduction of similar arrangements in the United States in 2003 concerning the so-called “Plan B” contraceptive pill. The US case provides an important study of the way religion and politics can be brought to bear on important public health policy decision-making, even when contradicting the best scientific advice available.
Plan B, the trade name for the emergency contraceptive drug levonorgestrel, was originally approved by the US Food and Drug Administration (FDA) as a prescription drug in 1999, on the basis of a thorough evaluation of safety and efficacy. Consistent with decisions taken internationally, the FDA voted to recommend Plan B as an over-the-counter drug in 2003 following the advice of two independent scientific advisory committees. Plan B was found to meet all the scientific criteria for an over-the-counter drug, being non-toxic and non-addictive and not requiring prior medical screening of users.
However, in what is considered a largely unprecedented decision, the acting director of the FDA’s Center for Drug Evaluation and Research, Dr Steven Galson, overturned the recommendation and declared Plan B “not approvable” for over-the-counter status. His argument that the available research was insufficient to demonstrate Plan B’s safety in adolescent girls was widely dismissed as specious: the New England Journal of Medicine described the reasoning as being in “serious error”.
Following the controversy, the manufacturers of Plan B submitted a new proposal to sell the drug on a nonprescription basis but from behind the pharmacy counter, so that its use could be restricted to women over the age of 16. However, in another unprecedented move, the FDA head, Lester Crawford, announced the indefinite postponement of any review, effectively prohibiting the drug from being sold without a prescription to users of any age. Both of these major policy decisions were noteworthy because they represented a clear intrusion of politics into public health: in both cases, clinical judgments provided by specially appointed expert groups were overturned by bureaucrats appointed by the political administration of the then President, George W. Bush. In 2006, the FDA eventually achieved an arrangement where Plan B would be available without prescription for women aged 18 or over (and only with a prescription for women younger than 18). Later, in 2009, a court ruling led to the minimum age for non-prescription availability being reduced to 17.
The initial reticence of politically-appointed FDA key decision-makers to follow the standard approval procedures, and to ignore the counsel of its own scientific advisors, was widely interpreted as reflecting a religiously informed political stance. This was based on the (Christian) interpretation that, by preventing the implantation of an egg in a woman’s uterus after ovulation (an occurrence that arises only in some cases), emergency contraception constitutes post-conception abortion. That the final decisions were political/religious is not disputed even by those accused of bias. For example, Bush-appointed scientific advisor on women’s reproductive issues, one Dr David Hager, claimed of his own role in influencing the decision that “God has used me to stand in the breach”. As well as advising the Bush administration on women’s reproductive health, Hager was the author of As Jesus Cared for Women—Restoring Women Then and Now.
However, such attitudinal perspectives stand in conflict with a wide range of internationally gathered scientific evidence which suggests that the advantages of emergency contraception to women’s health far exceeded the costs. For one thing, while making emergency contraception available on an over-the-counter basis appears to result in greater general awareness about the medication, it doesn’t appear to change the frequency with which it is used or the overall level of sexual activity in women. In fact, this increased awareness about emergency contraception appears to be directly beneficial. The evidence suggests that awareness of emergency contraception is associated with higher levels of contraceptive diligence and less risk-taking. At worst, studies have shown that availability makes no difference to levels of sexual activity, spread of sexually transmitted infections, numbers of pregnancies, or abortion rates. In fact, several studies have shown that over-the-counter availability is associated with reduced levels of unwanted pregnancies and fewer abortions.
It is somewhat sobering that the main lesson here is that, essentially, the weight of scientific evidence for or against the safety and efficacy of emergency contraception has had only a modest impact on decisions taken with regard to its availability to women. In the US the decision-making process became compromised by politico-religious determinism, while in Ireland it was apparently intertwined with capitalism and pragmatics. No doubt the authorities in both countries will claim that the safety of women and the advice of scientists was of paramount importance to their decisions. However, the events themselves seem to suggest that scientific approval was, in fact, a mere footnote to proceedings.