Just in time for the holidays, Fortune magazine has a disheartening look (from the industry’s perspective) at the FDA, showing that new drug approvals are down (only 15 New Molecular Entities this year - likely to match a 10-year low). The reason: “…the FDA has raised the bar, demanding that the new drugs aren’t just safe and effective, but more effective than currently-available treatments.”
In the age of “personalized medicine,” it seems odd to limit a doctor’s choices for treatment. Certain subpopulations will always respond better to an alternative treatment than the standard of care. As a regulatory body, the downside of another scandal may be a greater motivating factor than the interest of providing patient options. Or, as the CEO of Schering-Plough put it, “When bureaucrats come under pressure, they tend to choose the path of asking for more data, as opposed to approving the drug.” Or the tech adage, “Nobody ever got fired for buying IBM.”
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