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FDA increasingly scrooge-like on new drug approvals
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.”
The FDA won’t get credit for the next blockbuster treatment; they only get slammed when something goes wrong. Not the greatest environment for innovation. Industry continues to lose money on increased testing, and delays in approval (shrinking the on-patent window). When dealing with patients, safety must be a chief concern. But is being too safe also a concern? The debate goes on.
Kevin Downing @ MaRS
Kevin currently manages initial client engagements with the MaRS Venture Group. He also administers a federal fund that provides mentorship to start-up companies across Ontario.
