A customer base of people with profoundly serious troubles at the edge of desperation who are looking for any glimmer of hope. An industry who's incentivized to charge astronomical amounts to an untapped market to recoup costs. A drug that seems to have failed based on multiple trials and 3 separate expert review teams. Now remove the approval requirements. What could possibly go wrong?
It's easy to yell paternalism but this doesn't look like a case of paper pushers getting in the way of a promising drug to me. Also, history is littered with examples of why "buyer beware" does NOT work, and a vast literature on information asymmetry, adverse selection, "The Market for Lemons", etc etc. Also, the FDA already has mechanisms to speed up new drugs getting to patients when the benefit is clear early on, AFAIK.
It's easy to yell paternalism but this doesn't look like a case of paper pushers getting in the way of a promising drug to me. Also, history is littered with examples of why "buyer beware" does NOT work, and a vast literature on information asymmetry, adverse selection, "The Market for Lemons", etc etc. Also, the FDA already has mechanisms to speed up new drugs getting to patients when the benefit is clear early on, AFAIK.