FDA: Hazardous to Your Health
When people age, the main valve carrying blood out of the heart becomes brittle. As this aortic valve narrows, it can cause debilitating heart failure, and even death. Fixing the problem in the United States requires open-heart surgery. In Europe, the problem can be repaired using a tiny catheter that introduces a replacement valve through an artery in the leg. In July, a Food and Drug Administration advisory panel said this device should also be approved for sale in the U.S. It is expected to reach patients by year end—more than four years after it first hit the market in Europe.
…more than 15,000 patients world-wide will receive the device by the time it’s slated for approval in the US. Some Americans healthy enough to fly have sought the procedure in Europe. Tens of thousands of Americans unable to travel, and too sick to undergo open-heart surgery; have died during the intervening four years.
See Scott Gottleib editorial in the Wall Street Journal
That’s tragic. It is yet another example of bureacracy and overregulation interfering with the promise and potential of innovation.
The FDA absolutely takes way too long in approving medical devices and drugs. Certainly, in a number of instances whatever device that is being considered for approval could be harmful for a very small percentage of people – that’s what the FDA says it is concerned about. But to make everyone else who would benefit wait because of the small possibility that a device (or drug) could harm a very small number of people is not warranted. The agency’s good intentions of being extra careful and extra thorough in the approval process seem to often be indirectly harmful to those people having to wait.
Maybe the Consumer Products Safety Commission could outlaw the FDA.
Considering how integrated the marketplace is, it would make sense for the industrial countries to work together and have a single international agency in charge approvals. Even if each country did not follow all recommendations, they should at least try to avoid duplication of effort.
Seventy-five percent of medical device firms launch new products and seek approval for their new devices overseas rather than navigate the FDA’s cumbersome approval process.
I just ran across this quote by Margaret Hamburg, commissioner of the FDA speaking about the need for more medical device development.
That’s the trade-off that the FDA makes in trying to keep the public safe. While they’re taking forever to approve drugs and devices, they’re also not allowing drugs and devices to enter the marketplace. It all depends on what disease you have as to whether or not the FDA process is helpful to you. Either they save you from taking a drug that might be harmful or they stop you from taking a drug that might cure you. Same with devices.
As history shows, this type of overregulation can kill thanks to the FDA’s system for approving medical devices which inefficient and ineffective. With the Medical Device Amendments, Medical devices came under official FDA control in 1976 leading to an increase in delays and cost associated with medical devices.
Let’s not forget the Sensor Pad fiasco.
http://eng.am/pQifEU