The Medical Device User Fee Amendments bill that Congress passed this year is more than an FDA fees hike for device companies; it could inhibit innovation, says Michael Drues, a regulatory consultant based outside Boston.
That’s because MDUFA 2017 includes new user fees – about $23,000 for small companies and $93,000 for large companies – for requests for de novo device classifications. Drues, who has worked with both device companies and FDA, has clients speeding up de novo applications to get them turned in before the fees take effect on Oct. 1.
“I can think of no better way to stifle or kill innovation than by imposing those kinds of fees, specifically on the de novo,” Drues said. (See Drues moderate a regulatory panel at DeviceTalks Boston on Oct. 2.)
A better solution might be modest fees – perhaps $1,000 – $2,500 – for the hundreds of pre-submission meetings taking place at FDA each year, according to Drues.
Listen to the full MDO podcast with Drues:
Our government has created such a hostile business environment that we are at a point where we have lost our momentum in the steel, aluminum, auto, tool and die, plastic, electronic, medical, and even pharmaceutical industries to name a few. We are not allowed to mine our natural resources and agriculture doesn’t pay like it used to. This situation has gotten so bad that even when we develop a new technology the physical products of that technology are typically made elsewhere. The result is, we lose the intellectual property and much of the revenue it could have produced if we made the products here! Now you are telling me that is not enough devastation to our vital productive infrastructure. Instead of the government actively supporting the development of new technologies and markets that benefit American companies it is a leach! This is not a way to improve America it is another impediment. I hope America survives the collective lack of reasoning in legislature.
Thanks for the comment, Dan.
It should be understood.. “de novo ” is a relatively new alternative to creating new product classifications for the FDA.
An attempt to stream line/ speed up the bureaucracy for defining and accepting truly NEW classifications of medical products.
At best…..a half measure, to improve upon the already confusing , byzantine labyrinth of government regulations related to bring a medical product to market.
Ultimately the result of the conflict between “demands for improvement / integration of new technology” VS “safety”.
The “fee” process to qualify innovation, safety, etc. ? …requiring those taking risks (and possible rewards) to pay for the regulation (safety, protection of IP, etc.)?
This has a spotty record in the US.
When it works.. politicians tend to exploit it.
Example: the patent office during the 70/ 80s.. was making money and congress spending this money elsewhere.
Fine (sharing of the general fund) , but the resources we not available to be spent in preparation for the massive influx of applications during the 90/00s…. creating a rubber stamping of millions of questionable patents.. creating economic instability.
Granted, no one really knows the future or all the consequences of every decision.
However, the results of some decisions are not that hard to predict.
Very good point, John.