If drug approval were an Olympic sport, the United States would be the team to beat in London this summer.

According to a new 10-year study, it took the FDA 322 days, on average, to approve new drugs. That’s 45 days faster than Europe. And it’s 70 days faster than Canada!

U.S. takes the gold!

The study completely ignored drug safety. It also ignored follow up studies that reveal drug problems. And drug recalls. All those issues are also-rans in the race to approve new drugs.

Naturally, speed is important to drug company executives. They want to get their products out there ASAP. That’s not how they put it, though. They say it’s all about “innovation” and “saving lives.”

Meanwhile, Congress is pushing the FDA to move even faster. One plan is to relax certain regs so that drug companies can conduct smaller and shorter clinical trials.

And what about drug safety? Please. Don’t even bring it up.

I have one note for Congress and the FDA. It’s something my mother always said whenever she thought I was eating too fast. “It’s not a race!”

Sources:
“Study: US Clears Drugs Faster Than Europe, Canada” PharmaLive, 5/16/12, pharmalive.com


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Allan Spreen, M.D.
Dr. Allan Spreen, Chief Medical Advisor

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