Combating Resistance: Federal Efforts to Reduce Overuse, Curb Misuse, and
Incentivize the Development of Antibiotic Drugs
Donna Hanrahan.................................................................................................................. 67
Inappropriate and underregulated use of antibiotics threaten public health by increasing
antibiotic resistance of bacterial infections, and in turn, making them more difficult to
treat. This article emphasizes the need for legally binding standards to reduce misuse and
stimulate the development of antibiotic drugs. It suggests that the Food and Drug
Administration (FDA) impose a Risk Evaluation and Mitigation Strategy (REMS)
restriction on novel antibiotic drug products to conserve their use and prevent misuse.
Further, this article urges Congress to implement statutory reform to incentivize
innovation in antibiotic development. Passing new statutory and regulatory guidelines
will take time, coordination, and perseverance. Until a new regulatory regime
surrounding antibiotics is established, policymakers should work within existing statutory
frameworks to curb resistance by using the Orphan Drug Act (ODA) to spur antibiotic
innovation and the Controlled Substance Act (CSA) to promote antibiotic conservation.
