When pharmaceutical companies want to introduce a new medicine to U.S. patients, it must first go to the Food & Drug Administration (FDA) for approval. After this, these medicines go to the Drug Enforcement Agency (DEA), where that agency must approve them, too.
This bill aims to accelerate the approval process by requiring the DEA to come to a scheduling decision within 60 days of a drug product passing FDA approval.
This legislation would also speed up the process to bring new drugs under a clinical trial. The DEA would be given a 180 day window to approve or deny an application to manufacture a controlled substance (Schedule III, IV or V) for clinical trial.