DEA decision makes diagnostic agent more widely available

Diagnostic agent DaTscan (Ioflupane I 123 Injection) is no longer listed as a Schedule II controlled substance under the Controlled Substances Act (CSA) by the Drug Enforcement Administration (DEA), making it more readily available for use in the diagnosis of Parkinson’s disease.

The agent helps make dopamine transporters in the brain visible, leading to more accuracy during the diagnosis of Parkinson’s disease. Access to the agent was limited to only specific healthcare professionals while it was listed as a Schedule II controlled substance.

Back in July, the DEA released a Notice of Proposed Rulemaking (NPRM) stating that the FDA-approved agent had been appropriately researched and could safely be removed from the CSA. That proposal is now official.

At the time of the DEA’s NPRM, the American College of Radiology issued a statement saying it supported the move, and that DaTscan will help improve the overall quality of patient care in the U.S.  

The diagnostic agent is manufactured and distributed by GE Healthcare, and the company issued a statement this week praising the DEA’s decision.

“We fully support the DEA’s decision to remove ioflupane I 123, the active ingredient in DaTscan, from the Schedules of the Controlled Substances Act,” Etienne Montagut, global product leader of neurology and cardiology for GE Healthcare, said in a statement. “Because of the DEA’s decision, this important imaging tool will be more widely available to the medical community. Increasing the availability of DaTscan helps us fulfill our commitment to provide innovative, high-quality, and affordable healthcare solutions to patients who need them most.”