Feature

Business columns: The drug development bottleneck

The bottom line is that drugs that one day could save or prolong lives are simply not being produced,” said Christoph Westphal in The Boston Globe.

Christoph WestphalThe Boston Globe

How is it that we still have no effective treatment for Alzheimer’s disease, though it strikes one in eight Americans over 65? asked Christoph Westphal. Blame the U.S. drug development process, which “is becoming too costly, lengthy, and risky.”

It now takes 10 years and costs more than $1 billion to develop a new drug and bring it to market, largely because of “ever-expanding regulatory requirements.” The Food and Drug Administration demands multiple studies of a drug’s effect on cells, animals, and ultimately human beings before approving a drug, and even then, there’s no guarantee that approval will be forthcoming. Indeed, nine out of 10 drugs in development never win FDA approval.

The pharmaceutical industry’s reaction to this state of affairs is predictable. Big drug companies are slashing research budgets, and small biotech firms, which often handle the early stages of drug development, “are reducing headcount or shutting down.” The bottom line is that drugs that one day could save or prolong lives are simply not being produced.

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