FDA, Industry Love Fest Formed – But Where is Patient Safety?

The U.S. Food and Drug Administration announced this week it has formed a collaboration with medical device manufacturers in order to speed up the development and approval of devices.

The nonprofit group is called the Medical Device Innovation Consortium (MDIC) and is made up of industry, academics as well as the FDA. Reuters reports advocacy groups content the FDA is not putting patient safety first.

Searcy Denney has learned the founder of one patient advocacy group, Truth in Medicine, received her invitation to attend, November 29, four days before the announcement between the MDIC and the FDA’s Center for Devices and Radiological Health (CDRH), which oversees medical devices. So did the founder of the Failed Implant Device Alliance. Patient groups were told it would cost $5,000 to join. So much for being all inclusive.

“It really is going to represent a model that will be watched carefully, will be replicated. I know there will be real advances and new approaches that will emerge from it,” FDA Commissioner Margaret Hamburg told reporters on a teleconference.

The consortium includes Medtronic, Boston Scientific, Becton Dickinson and Co., Abiomed and Cyberonics. LifeScience Alley, a Minneapolis-based industry group, founded the nonprofit which also includes the Mayo Clinic and University of Minnesota. Minneapolis is considered a medical device hub.

Beyond descriptions such as “creating a vibrant medical device industry” with profits as the goal, the MDIC says, almost as an aside, it will “serve the public health needs of the U.S.”

Unless the public at large benefits from faster device approvals, this appears to be just one more step toward a taxpayer funded agency that’s serving the needs of the medical device industry.

Medical device makers have long criticized the FDA for taking too long to review devices. The claim is it slows down development of important new technologies.

The truth is that most medical devices are approved through the least burdensome 510(k) approval process which takes a few months and about $4,000 in investment. That doesn’t sound like much of a burden.

Consumers Union in a poll taken last March, found consumers want safer medical devices, not faster approvals.

The poll revealed that 82% of Americans believe that preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation. And 91% of respondents said each implant should be safety tested before being sold, even if it is the “substantial equivalent” of a device already on the market.

It is very difficult for the FDA to serve two masters and it appears which one is taking a leadership role with the formation of this new partnership.