A friend and I were having a conversation about health policy the other day when he observed that drug regulators like FDA face an impossible task in terms of public expectations: as consumers, we expect the drugs we take to be 100% safe, 100% of the time. Of course, no regulator, no matter how powerful or well funded, could deliver on that expectation, and the reality is that FDA operates under a variety of limitations, both fiscal and legal.
The current deadly meningitis outbreak linked to contaminated injections made by a Massachusetts compounding pharmacy shocks us and upsets our expectation that the drugs we take to get better will not, at the very least, cause us harm. Responding reflexively to this crisis, many in the media and in Washington have already started to call for greater federal oversight. This is a natural impulse, but one that merits cool-headed consideration. FDA is an agency that already has a broad statutory mandate and limited resources. Enforcement resources are slim enough that the agency’s response to an HHS report this month finding rampant violation of dietary supplement-labeling laws was simply to say that the agency would “address the recommendations as its resources and priorities allow.” Before we add still further to FDA’s crowded plate at a time when it is already facing a potential budget crisis (and it is worth noting that according to at least one former FDA chief counsel and congressional testimony by agency officials, FDA already possesses the authority to regulate pharmacies like the one involved in the outbreak and historically has done so), it is worth asking whether FDA enforcement is the only or best solution to the problem.
While I don’t pretend to be able to answer that difficult question in a blog post, the first step in addressing it meaningfully is to ask what exactly the problem here was. There are, after all, different types of drug safety disasters: there are those that occur in the absence of regulation or because regulations in place are insufficient or badly conceived, but there are also those that occur in spite of effective regulation, either through the malicious or selfish acts of corner-cutting individuals or through tragic but unavoidable accidents. The current system, under which pharmacies are regulated by the states, drug manufacturers are regulated by FDA, and borderline cases are handled by FDA on a discretionary (and contested) basis, may not be perfect, but the conversation about dividing these responsibilities up is not a new one (see here and here) .
Even accepting that the problem here was caused by “scant oversight” as opposed to, say, ethical lapses at the relevant regulatory body (it has already come out that an executive of a company related to the pharmacy that produced the contaminated injections also serves on the board of the state agency that regulates pharmacies) we should not uncritically accept that additional regulation must come from Washington. After all, if states took it upon themselves to impose greater limits on companies identifying themselves as pharmacies but acting like manufacturers, these kinds of accidents could be averted. Public health is not just a national issue, it’s also an intensely local one: if I were a governor, public health official, or legislator in Massachusetts or in any state where this outbreak has claimed a victim, I’d be hard at work right now exercising the states’ traditional role in this sphere.