The FDA Is Killing Us
In November, the U.S. Food and Drug Administration (FDA) approved an innovative product called the Sapien Transcatheter Heart Valve, for the treatment of severe aortic valve stenosis. The Sapien valve can be implanted endoscopically, making it a boon for patients who are too sick to endure open-heart surgery. Clinical trials found that almost 70% of patients receiving Sapien valves were alive one year after treatment, while only 50% of those receiving alternative treatments survived that long.
This would be a great story for American patients, but for one frustrating detail: The Sapien valve has been available in Europe since 2007, saving lives there but not here.
More on the FDA’s unnecessary regulatory burdens in the WSJ.
Due diligence is good, but sometimes we take it too far.
The FDA goes beyond due diligence, Alex. They are nannying people.
It’s one of the worst agencies in America, in my view.
Patient safety advocates preach that due diligence is important and devices should not be approved too quickly. However, there is a trade-off between those who might die from a faulty device approved too quickly (Type I error) and the number of people who might die because they were denied access soon enough to benefit (Type II error). There should be a middle ground where device (and drug) makers can market their products to patients earlier coupled with extensive post-market monitoring. For instance, why wasn’t this device offered to patients in the U.S. in 2007 and then the results closely monitored?