Ema of The Well-Timed Period comments on the plan by the Wisconsin Attorney General to sue the FDA for failure to authorize OTC sales of emergency contraceptive “Plan B”:

In my opinion this is like treating the symptoms without addressing the cause. A court of law (or, for that matter, the political arena) is not the appropriate venue to decide whether Plan B should, or shouldn’t be available OTC. Alternatively, if you really must go the lawsuit way, I say do it the right way. Start making Plan B available OTC immediately, in defiance of the FDA’s political ruling, and force the politicians who object to make a [scientifically sound] case against it.

[brackets original]

Her concern about courts of law is that they are simply another way for non-scientific rulemaking to enter the health-policy field. She appears to regard trial-based health-policy rulings as no more preferable than ideologically-driven legislation or regulatory stonewalling. I think she has a point in this (the history of “junk-science” cases in the courtrooms bears her out).

However, I am not convinced that it is as simple as simply opting for “science-based” policy-making. Any bioethicist will immediately respond that policy decisions are inherently value-based - they take scientific fact as one relevant consideration, but no scientific fact stands on its own, or dictates the one, true, obvious policy that must follow from it.

I am not endorsing the FDA’s shameless politicking with Plan B, or the right wing’s constant obstructionism and misogynist intrusiveness over abortion, but it is also true that neither Plan B distribution nor abortion are justified simply because they are very safe, or even because they are safer than their likely alternatives. However loudly those facts speak, they do not “speak for themselves” - they must be placed in the context of whatever values are served by policy-making. If abortion really were “murder”, it wouldn’t be justified even if it was safer than childbirth (as in fact it is); if teen sex really were as icky as the Bush Administration’s evangelical medical corps believes, OTC availability of Plan B might not be justified even if it prevented unwanted full-term pregnancies. We must have some sense of where we stand on the moral values implicated by certain behavior in order to make policy for that behavior - and in that kind of decisionmaking, scientific fact creates the practical context which must be taken into account, but it does not dictate answers. This is why we cannot simply leave policymaking to scientists, even if we dare not leave it to politicians. (And why we must engage the moral debate over sex and abortion in a way that the pro-choice contingent largely has not so far.)

For similar reasons, I think her plan to force the FDA’s hand is commendably bold, and might bring salutary political results, but as a matter of proper regulatory approach it is misguided. It is important to have prior review of major healthcare policy decisions such as the introduction of powerful new drugs. Drug-safety regulation has brought incalculable benefits to the US and the world, and back when we had a professional and scientific regulatory agency the system - for all its flaws - was both necessary and effective. We cannot put the burden on the FDA to “rule out” dangerous drugs after they have been introduced in the marketplace - that is their regulatory mandate regarding “health supplements”, which is proof enough of what a disaster it would be for prescription drugs. We also cannot allow manufacturers to simply vacate the regulatory review requirement whenever they determine that the FDA has not behaved responsibly - it requires no imagination to see what the result of that policy would be. If the FDA has behaved in bad faith regarding one drug or class of drugs - as it unquestionably has - that problem must be addressed directly, preferably by turning the entire pack of pinheads and fanatics out of office at the first opportunity. It might even be useful to impose limits on the FDA’s discretion to overrule the advice of its scientific review committees. But there are few legal grounds for challenging a policy decision simply because it is discriminatory or hostile to a group’s interests. The protest move Ema recommends would necessarily be a challenge to the FDA’s internal procedures - the fact that it is stonewalling - not to the fact that the agency is now held captive by right-wing religious fanatics who hate women and sex. The latter is not - in the absence of a women’s Equal Rights Amendment - a legally-cognizable reason for violating a regulation; the former is procedurally weak, but more important would open the floodgates to any commercial manufacturer who wanted to claim they had been harmed by the FDA’s review process - something we definitely do not want.

As much as I share Ema’s frustration, I think this is a fight we have to win on the merits, not by claiming legal rights to do what other drug makers should not be allowed to do.