Cures Act Leaves Combination Product Issues Unresolved
Two prominent Washington D.C., attorneys believe the 21st Century Cures Act did not go far enough to fix a bias against devices in the classification of combination products.
In almost every case, a combination product involving a chemical action is automatically referred to the Center for Drug Evaluation and Research regardless of the device component, said David Fox, a partner with Hogan Lovells — a former counsel to FDA’s combination products programs and former associate chief counsel for drugs — in an FDAnews webinar.
The Cures Act codified the FDA’s guidance on primary mode of action (PMOA), but also established that simply having a chemical action was not sufficient grounds to automatically refer a product to CDER.
Going forward, an additional legislative solution, perhaps as part of the upcoming reauthorization of FDA user fees, is more likely than FDA action to make up for the Cures Act’s shortcomings, Fox said.