Senate's HELP committee passes drug scheduling bill

The U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) passed S. 481, a bill to reduce regulatory waiting periods for therapies that FDA recommends for controls under the Controlled Substances Act.

The Improving Regulatory Transparency for New Medical Therapies Act would require the Department of Justice to issue final interim rules on scheduled drugs within 90 days of FDA approval. Marketing exclusivity periods would begin when DOJ issues its final interim rule or when the drug is approved, whichever comes later. ...