New Law Aims to Improve Regulatory Transparency for Recently Approved Controlled Substances

Signed into law by President Obama, the Improving Regulatory Transparency for New Medical Therapies Act (HR 639) amends the Controlled Substances Act (CSA) so that newly approved controlled substances are scheduled more quickly and are available sooner for health care providers to prescribe to patients. Specifically, the law requires Drug Enforcement Administration (DEA) to make a scheduling decision within 90 days of when Food and Drug Administration (FDA) approves a new controlled drug that has abuse potential or when FDA sends a scheduling recommendation to DEA. Prior to the passing of this law, after FDA approved a new drug as safe and effective, there was no schedule or deadline for DEA to make a scheduling decision, according to the House Report.