Why are CEO's held liable for any action that their company takes (Sarbanes-Oxley), but public officials aren't even responsible for their own actions (qualified immunity)?
Wednesday, February 01, 2012
I got an email from Consumer Reports today advocating tighter regulation of medical devices by the FDA. Here is my response with a copy of the original email below:
This approach would simply raise the costs and increase the time associated with getting medical devices into the hands of the people that need them most. We have already seen how the FDA approval process for drugs has slowed innovation and increased time to market by decades. The last thing in the world that I want to see is this failed model super-imposed on medical devices.
It's a nightmare scenario. The implant that fixed your knee or your heart may actually be a ticking time bomb that could disable or kill you.
This isn't science fiction. Millions of medical devices including artificial hips, contact lens solution, heart stents, and pacemakers are being recalled - 700 different products a year.
And the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were "similar" to products already on the market.
Tell Congress we don't want to be guinea pigs anymore!
Every new prescription drug must undergo rigorous testing on humans before it can be sold, even if it is similar to another drug already in use. Not so with medical devices. Because of this loophole in our safety laws, more than 90 percent of medical devices aren't safety tested before being sold nor are they routinely tracked afterwards to identify safety problems.
For example, a metal hip implant marketed by Johnson & Johnson was approved in 2005 without first undergoing clinical safety trials. It was recalled five years later after having a 1 in 8 failure rate in the UK, and releasing potentially toxic metals into the body. Countless patients had to undergo a second, painful 'revision' surgery.
It's time safety standards for medical devices are as strong as those for prescription drugs! E-mail your members now!
The device industry has unleashed an army of lobbyists and they don't want things to change. It will take a wave of consumers weighing in to make sure medical devices are safe and effective. Please take action, then forward this to friends and family. Thank you!
President, Consumer Reports
101 Truman Ave
Yonkers, NY 10703