It’s reasonable to propose making statins available over-the-counter (OTC), which is exactly what Alex Kesin recently did. However, this shouldn’t happen with the stroke of a government official’s pen. Instead, it should happen by applying the existing regulatory framework. If current regulations are overly convoluted or slow, they should be improved. Making decisions like this solely based on an official’s judgement will in the long term result in uncertainty and abuse.
Most organizations have too much process. Through my time in management consulting and the biotech industry I have learned that corporations aren’t immune. Removing processes and leaving decisions up to individuals will typically result in better decisions, higher efficiency and more innovation. Some process is needed, but it has to be kept to a minimum.
Government is different. If government were run like a corporation, it’d be a dictatorship. Democratic government needs more process than corporations and give leaders less freedom to make decisions. Consider a continuum between two extremes. On one end, all decisions are made by a single decider. They may delegate, but ultimately all authority rests with them. On the other end, all decisions are made algorithmically, or through processes. The processes are defined and changed through other processes. All governments lie along this continuum, with dictatorships like China closer to the first extreme and organizations like the European Union closer to the second. The optimum position differs between countries, and it likely even differs between government agencies. I remain convinced that a regulatory agency like the FDA needs to be closer to the second extreme. I’m not sure how close or what that means in practice. What I know for certain is that a single official shouldn’t have the power make large decisions like this with the stroke of a pen.
Nehaveigur 