The Harm of Excessive Medical Regulation

We are far more attuned to the potential harms a new product may create than the potential harms a new product may avoid.  No regulator wants to face a Congressional committee – generally a bipartisan committee, incidentally, as indignant posturing and self-righteous outrage seems easily to cross party lines – demanding to know why an approved drug was ultimately discovered to cause unexpected problems.  Raise the bar for approval high enough and you reduce the likelihood of this occurring.

Unfortunately, far less attention is paid to the reverse – to the very real patients who never receive a new medication because excessive regulation resulted in prohibitively high hurdles, effectively dampening work, disincentiving investment, and stifling progress.

Perhaps this is the policy we want: regulators face an admittedly formidable challenge (essentially, predicting the future), and in some cases, as I’ve explicitly noted, have been way ahead of the curve – for example, in highlighting the very real need for more investment in assessment science.

Yet, as regulators seek to weigh the potential benefits and risks of a new medicine, my own observation is that they tend to be both tentative and ultra-paternalistic; many seem to feel they must somehow protect doctors from themselves, and the result is that patients are systematically denied access to medicines that might be useful, and for whom the risk/reward, when fully understood and discussed with their physician, would be worth it.