Biogen, a biotech company worth over $30 billion, just got FDA approval for a $56,000 Alzheimer’s drug that is not proven to be effective. When I read this, I was inundated by the stench of regulatory capture emanating from this approval. Not only does this affect those who need the drug, the average Medicare Part B (medically-necessary services) insurance premiums will rise by over 14%. Biogen might be the most recent offender, but this analysis has led me down a rabbit hole tattooed by a theme of capitalism not caring about virtue.
What I find most stunning is that the FDA seems to see no immorality in having massive companies push through layers of internal dissension to get approval for drugs that are not fully studied or proven to be clearly effective. That seems wrong to me. Capture seems like a mostly-fair side effect of a free market system, but that doesn’t mean it should rear its head in every bureaucracy without anyone batting an eye. Normally regulatory capture deserves careful thought, but not diligent combat. In the case of the FDA, combat seems most appropriate. There’s a difference between the shipping industry seeking fixed-prices and individual companies within the biotech industry seeking barrier control. The latter deals with potentially life-saving medications that have real physiological impacts (on top of financial impacts) on a large portion of our population.
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