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Patents were given some consideration, but the discussion neglected to note that for small molecule (Hatch-Waxman effected) drugs, the primary patent is the chemical structure termed ‘composition of matter’. I second would have preferred a bit more discussion on what protections the pharmaceutical industry has for small molecule drugs. These are often more expensive to develop, but enjoy longer and often more stable product cycles. Hence, one consequence of Hatch-Waxman has been a shift by pharmaceutical developers to focus more on biologic drugs. Generic biologics or biosimilars still require efficacy testing for approval. Biosimilar drugs are generally not ‘identical chemical entities’, and analytical assay technologies that can establish ‘equivalence’ for these entities are still today not as mature as the ones we have had for small molecules since the 1980s. This and other improved analytical chemistry technologies allowed for FDA approvals without the need for confirming efficacy trials. HPLC separations combined with detection by mass spectroscopy enabled validated sensitive measurements of small molecules in the bloodstream (and urine) that serve as the basis for establishing pharmacokinetic ‘bioequivalence’. The years prior to Hatch-Waxman were certainly favorable to the pharmaceutical industry, but a technology advance as much as the legislation birthed the expansion of the genetics industry in the 1980s. small molecule, often chemically synthesized drugs and not biological drugs that are grown and/or cultured. It is a bit of a unique industry in that it competes with its past success in a manner unlike other industries.įirst, I would prefer the discussion made clear that Hatch-Waxman only refers to drugs approved through CDER (The Center for Drug Evaluation and Research) and not CBER (The Center for Biologics Evaluation and Research) i.e. There is much about which the industry should be shamed, but at its core improving health is a noble pursuit. I have a bias in favor of the pharmaceutical industry. And the hard one how can it be guaranteed that those served are the ONLY customers. The easy one how would the market solve the information problem of customers.

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First ask what is wrong with dictators who claims the interest of those served, making mistakes once in a while? How serious are those mistakes, (power corrupts etc.) compared to the severity of mistakes made by those who really are those served customers, who lack the technical information perhaps.Īssuming free markets is a better way to avoid complexity –where complete discretion is with the customer– there remains two problems. No complexity just judges who have the interest of those served. Perhaps the solution should instead revolve around the concept of complete discretion even if it means accepting some amount of abuse and dumbness. It was to simplify the complexity not get rid of it. At the very end of the interview there was less than a minute on solutions. They secretly love the complexity just as those who do pharmaceutical arbitrage secretly love complexity. Even if once in a while they make a mistakes, surely the efficiency bla bla etc. Throughout the interview, I kept thinking, why hasn’t it occurred to the government to create thousands of government drug czars who just decides everything. “We should thank God for bureaucracy, for without it the power of the State would be at the discretion of a multitude of dictators.” I don’t know where I heard it but I think it leads to one of the most important questions in philosophy.Ĭomplexity of government interventions is most evident in the subject of today’s interview regulatory environment of pharmaceuticals.

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