The FDA is already floundering, the plan burries them
AAM 20 [Association for Accessible Medicines “GDUFA-Reauthorization Primer “, https://accessiblemeds.org/sites/default/files/2022-01/GDUFA-Reauthorization-A%20Primer-01-2022.pdf published 2020, accessed 6-11-2024]
Following the enactment of the Hatch-Waxman Act — the law that created the ANDA pathway — generic drug submissions to FDA grew substantially, straining FDA’s resources to review ANDAs on a timely basis. As a result, generic drug reviews were often sluggish and unpredictable.
Over time, FDA’s backlog grew to several thousand ANDAs, and the average time to approval exceeded 30 months, hampering patient access to quality, lower-cost generic medicines. To help ensure FDA continues to have sufficient resources to carry out its mission, Congress enacted the first Generic Drug User Fee Amendments (GDUFA) in 2012.