USA – GDUFA III: Use MDUFA model to create competition in generic drug markets

As negotiations for the reauthorization of the Generic Drug User Fee Act (GDUFA) continue, stakeholders should consider a new financial model to improve equity and competition in generic drug markets, according to a recent Health Affairs blog post.

GDUFA was enacted in 2012 and reauthorized in 2017 as GDUFA II with the goal to “supplement FDA funds to expedite generic drug approval and inject competition in generic drug markets,” Margaret M. Dotzel, attorney and former deputy general counsel at the Department of Health and Human Services under the Obama administration, and colleagues wrote.

Both GDUFA and GDUFA II have had success in expediting generic drug approval, the authors acknowledged. Under GDUFA II, user fees have been responsible for between 58% and 76% of the Office of Generic Drugs’ operating budget, and the projection for 2021 is estimated at $692 million…