Opinion: Former FDA commissioner: ‘Cost-cutting’ may undo one of Trump’s best drug pricing achievements
The recent dismissal of 13 FDA review staff eliminated precisely the kind of government spending that delivered the most bang for the taxpayers’ buck, writes former FDA Commissioner Scott Gottlieb.
President Trump often touted during his first term that his administration had “approved more affordable generic drugs than any administration in history.” He had good reason to highlight these accomplishments. Over the first two years of his presidency, the Food and Drug Administration made significant investments in staffing and policies for reviewing and approving generic drugs with an explicit goal: ensuring that once valid patents on expensive branded medications expired, these products would promptly encounter vigorous competition from lower-cost generics.
Over the past 20 years or so, the branded medications have become substantially more complex. Many are now formulated in ways that pose formidable technical challenges for generic copying, including peptide-based drugs such as Ozempic, drug-device combinations used as inhalers, and medications administered through patches, among others. By 2017, this mounting complexity had resulted in a growing roster of drugs whose patents had lapsed but remained unchallenged by generic competitors. Under the first Trump administration, when I served as FDA commissioner, we tried to correct this imbalance with our “Drug Competition Action Plan,” a strategic push to speed the approval of generic drugs by offering precise scientific guidance on replicating these complex medications.
