Removes {123I} ioflupane from being designated as a controlled substance

1 Co-sponsor

• Hugh T. Farley

Title of bill

An act to amend the public health law, in relation to removing {123I} ioflupane from the designation as a controlled substance

Purpose

To conform New York State statute to the federal controlled substance act by exempting ioflupane.

Summary of provisions

Section one of the bill removes (1231) ioflupane from the controlled substance schedules.

Section two of the bill is the effective date.

Justification

(1231) ioflupane, the active ingredient in DaTscan, is an FDA-approved radiopharmaceutical visual imaging agent that is used to help medical practitioners differentiate between Parkinsonian syndromes and essential tremors by allowing practitioners to capture detailed pictures of the dopamine receptors in the brain.

The technique used to administer the test involves the injection of DaTscan into a vein where it is then taken up by the brain's dopamine receptors. The receptors can then be imaged through a form of MRI scanning (single photon emission computed tomography, or SPECT) which then makes it possible to determine whether there is a reduction in function in the dopamine system, which usually occurs in the presence of Parkinson's disease.

Parkinson's disease is a chronic, progressive neurological condition that results from the degeneration of neurons in a region of the brain that controls movement and for which there is currently no cure. It is estimated that one million Americans are currently living with Parkinson's disease, with approximately 60,000 new cases reported annually, not including the thousands of cases that go undetected or misdiagnosed.

There is currently no cure for Parkinson's disease, but optimal treatment differs between Parkinsonian syndromes and other conditions like essential tremor that mimic Parkinson's. Physicians use DaTscan results to better differentiate between these conditions, which benefits patients and can also help advance Parkinson's disease research. Because of the miniscule amount of active ingredient in DaTscan required to administer the test, as well as the presence of radioactive material in the drug, it is effectively impossible to be used or diverted for any narcotic or pharmacologic effects.

In 2011, the FDA approved the use of DaTscan as a diagnostic tool in the detection of Parkinson's disease. In September 2015, the Federal Drug Enforcement Agency (DEA) subsequently removed DaTscan from the Federal controlled substances list. However, because New York State does not automatically make changes to the state's controlled substances list when the DEA takes an action, DaTscan still remains a Schedule II controlled substance in NYS. As a result of state and federal procedures that must be followed by medical practitioners to obtain DaTscan for use as a diagnostic tool, the use of DaTscan has been severely limited in NYS because of its presence on the state's controlled substances list. Other states that have adopted the federal scheduling status have experienced a dramatic expansion in patient access, particularly in areas outside of major cities, because of the immediate reduction in regulatory burden. Because of its unique ability to help diagnose Parkinson's disease in patients, it is important that NYS remove DaTscan from the controlled substance list so that it may be more widely available for use by medical practitioners to effectively diagnose, treat and research new treatment alternatives for this serious medical condition.

Legislative history

New bill

Fiscal implications

None

Effective date

This act shall take effect immediately.