J & J, Medtronic push back against TGA priority review proposal

Johnson & Johnson (NYSE:JNJ) and Medtronic (NYSE:MDT) are pushing back against the Australian Therapeutic Goods Administration’s proposed priority review pathway for medical devices, citing faults in the proposal that they claim will keep them from using it, according to a RAPS report.
The major medtech players said they had doubts whether the pathway, designed to hasten approval, would actually cut time to get medical devices to patients in the region. The companies also voiced concerns that the pathway could negatively impact new and breakthrough devices, according to the report.
“We have concerns that the current proposal does not actually allow for accelerated assessment but rather ‘front of queue’ processing. We are also concerned that only those technologies having substantial clinical data would be considered for priority review. This would seem to exclude promising new technologies that may have limited clinical data at the earliest stages of development, but would benefit from expedited review,” Johnson & Johnson wrote in feedback, according to the RAPS report.
Medtronic echoed the sentiment, saying it was concerned that the TGA’s expectation of clinical evidence would limit the pathway to only devices with a wealth of existing data, limiting the entry of promising new tech.
The companies said they worried they would be impacted negatively by the new pathways even if they didn’t utilize them, voicing concerns about ...

Source: Mass Device - June 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance johnsonjohnson Medtronic Source Type: news