House passes DEA scheduling bill

The U.S. House of Representatives passed H.R.639, a bipartisan bill that would require the Drug Enforcement Administration to schedule new drugs no later than 90 days after a drug is approved or when the agency receives FDA's scheduling recommendation, whichever comes later. It would also provide a timeline for DEA to register controlled substances for use in clinical trials. Reps. Joe Pitts (R-Pa.), Gene Green (D-Texas) and Frank Pallone (D-N.J.) introduced the bill, known as the Improving Regulatory Transparency for New Medical Therapies Act.

In addition, the bill would delay the start of marketing exclusivity for a new drug until the later of two events: its scheduling by DEA or its approval by FDA. Marketing exclusivity for new drugs currently begins upon FDA approval regardless of DEA actions. ...