Knee Implant Topic of Discussion at the FDA – Fast Track Approval Processes
Posted Sep 25 2009 10:21pm
I’m sure this won’t be the last device process that is questioned, but the good news today is technology with devices, as now you will begin seeing more implanted devices reporting data, how it’s working, problem areas, etc. This may be in the area more so of clinical trials, but who knows how far it will extend. For goodness sales, Goodyear has been putting chips in tires for years now to tell their tale, was the tire over inflated during use, underinflated, etc. Granted with human implants we are talking an entire different and much more complex system than just a tire by all means as a device is not a visitor as is a drug, it comes to live with you.
Back when this device was approved, such systems were not available yet for data reporting. In this instance we have a battle between scientists wanting more information and trials and a former FDA director that wanted it approved. Not being there of course, I would suspect what we are looking at is the old style Washington type of politics to see if any of that lead to the rapid approval here versus the recommendation of the science group. Back a couple years ago everyone at the FDA didn’t have a computer either. Now they are looking at involvement in these very areas, maybe cell phones too as they collect data? Simple example below:
Anyway, for devices in the future, you can expect them to have the potential of reporting data, and as a patient, this could be good as you could get a failing device replaced much sooner, or have the confidence that your device is working well on the other side. As transparency continues to evolve here, all the old style political junk will continue to emerge and be investigated too. This announcement comes on the heals of former FDA Commish just landing a job at at “think tank” with Newt Gingrich. BD
FDA staff scientists rejected ReGen's application for approval for Menaflex three times, citing concerns that patients might suffer adverse impacts or that the product would do little to help them heal from a torn meniscus. The company sought a fast-track approval that is given to products which are substantially similar to other products already on the market. But several FDA reviewers believed it was, in fact, a new product, which would have required extensive clinical trials proving safety and efficacy.
In late 2008, ReGen appealed to then-FDA Commissioner Andrew von Eschenbach. He ordered an expedited review by a panel of independent advisers and allowed ReGen input about the composition of the panel. The internal probe found that ReGen executives had unusual access to von Eschenbach and approval came after von Eschenbach met several times with members of the New Jersey congressional delegation. In December, von Eschenbach approved the company's application without any explanation for overruling the judgment of his staff.