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By Cheryl Bolen
Sept. 10 — The Drug Enforcement Administration issued a final rule scheduled for publication in the Sept. 11 Federal Register to remove ioflupane, the active ingredient in DaTscan, from the schedules of the Controlled Substances Act.
More than five years ago, the Food and Drug Administration approved GE Healthcare's DaTscan, a single-dose injectable radiopharmaceutical used to diagnose Parkinson's disease.
“The Parkinson’s Action Network (PAN) applauds the DEA for de-scheduling the active ingredient in DaTscan and allowing many more people to have access to this important diagnostic tool,” said Ted Thompson, chief executive officer of PAN, in a statement.
“Having this tool available for people with Parkinsonian syndromes and essential tremor will allow them to receive the appropriate diagnosis and treatment sooner,” Thompson said.
Prior to this rule, ioflupane was classified as a schedule II controlled substance because it is derived from cocaine via ecgonine, both of which are schedule II controlled substances. Under the Controlled Substances Act, each controlled substance is classified into one of five schedules based on its potential for diversion and abuse.
This classification restricted the use of DaTscan to highly regulated hospitals and imaging facilities licensed to handle schedule II substances and obstructed patient access to DaTscan, according to public comments submitted July 2 by PAN in support of the proposed rule to de-schedule ioflupane.
“This has forced many beneficiaries of this tool to travel great distances or fail to undergo the test at all,” the Parkinson's advocacy group said.
Other commenters argued the risk of diversion was minimal. According to comments by the American College of Radiology, with only miniscule amounts of ioflupane in the product, as many as 6,000 injections of the agent would be required to induce a pharmacologic effect.
The rule is set to take effect immediately on publication in the Federal Register, according to the unpublished version of the rule.
This action removes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on people who handle (manufacture, distribute, reverse distribute, dispense, conduct research on, import, export, or conduct chemical analysis of) ioflupane, it said.
The DEA's de-scheduling of ioflupane has been a slow process. The Department of Health and Human Services recommended that the DEA remove the drug from schedule II in November 2010.
In December 2014, attorneys and other interested parties said the DEA's delay in making a decision on the drug was restricting access to what is the only known diagnostic test for Parkinson's disease.
“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,” said Etienne Montagut, global product leader of neurology and cardiology for GE Healthcare.
“Because of the DEA’s decision, this important imaging tool will be more widely available to the medical community,” Montagut said in a statement. “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.”
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