The FDA Process Works
I was invited to serve as an advisor to the US Food and Drug Administration as they considered whether to allow a pharmaceutical company to sell a new drug called ximelagatran. There was a lot of hype amongst my peers. The studies that had been published looked very promising and everyone was eager for a drug to replace the blood thinner coumadin (warfarin).
The only problem was that the studies in totality did not prove the new drug was safe or effective, so the FDA decided not to approve the drug, based in part on the recommendation of the committee I was a part of.
The level to which the FDA scriutinized the data was impressive, as was the rigorousness of the investigation of the drug my the company. The process worked well, perhaps to the disappointment of a few investors.
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