BILL NUMBER: S9852
SPONSOR: SCARCELLA-SPANTON
 
TITLE OF BILL:
An act to amend the public health law, in relation to designated or
rescheduled drugs
 
PURPOSE:
Enacts the "Access to Innovative Mental Health Treatments Act"
 
SUMMARY OF PROVISIONS:
Section 1. The opening paragraph of section 3306 of the public health
law, as added by chapter 664of the laws of 1985, is amended to read,
there are hereby established five schedules of controlled substances, to
be known as schedules I, II, III, IV and V, respectively. Such schedule
shall consist of the following substances by whatever name or chemical
designation known, except as provided in subdivision six of section
three thousand three hundred seven of this title.
Section 2. Sbdivsion 5 of section 3307 of the public health law, as
amended by hapter777 of the laws of 2022, is amended to read, the
commissioner shall by regulation or emergency regulations, reclassify
any compound, mixture or preparation containing any substance listed in
Schedule I of section three thousand three hundred six of this title as
a Schedule II, III, IV or V substance, or exempt it from this article,
if that same compound, mixture or preparation is redesignated or
rescheduled other that under Schedule I under federal Controlled
Substances Act, or deleted as a controlled substance under Controlled
Substances, or deleted as a controlled substance under the federal
Controlled Substance Act. If the commissioner ats under this subdivision
and does not exempt the compound, mixture or preparation from this arti-
cle, the commissioner may only reclassify it to newly created subdivi-
sion in the same numbered schedule or a higher numbered schedule than to
which it is redesignated or rescheduled under the federal act. This
subdivision shall not apply to compounds, mixture, or preparations
described in subdivision six of this section.
Section 3. Subdivision 6 of section 3307 of the public health law, as
renumbered by chapter 164 of the laws of 2018, is renumbered subdivision
7 and a new subdivision 6 is added to read, notwithstanding subdivision
five of this section, if any compound, mixture of preparation containing
any substance listed on Schedule I of section three thousand three
hundred six of this title is approved by the federal food and drug
administration and is designated or rescheduled by the federal drug
enforcement administration' in a schedule other than Schedule I pursuant
to 21 U.S.0 section 812 and 21 C.F.R.Part 1308, such compound, mixture
or preparation shall, as of the effective date of such federal desig-
nation or rescheduling, be deemed scheduled under section three thousand
tree hundred six of this title in the same schedule that compound,
mixture or preparation is scheduled under the federal schedules of
controlled substances, without the need for further action by the
commissioner,
Section 4. This act shall take effect immediately.
 
JUSTIFICATION:
The United States currently faces a mental health crisis. Millions of
Americans, including an outsized portion of veterans and first respon-
ders, struggle with mental health conditions such as Generalized Anxiety
Disorder (GAD), Major Depressive Disorder (MDD), and Post-Traumatic
Stress Disorder (PTSD). Up to 60 percent of patients grapple with medi-
cation resistance, and cycle through treatment plans. GAD, for example,
is among the most prevalent mental health conditions, yet a new medica-
tion to treat GAD has not been approved in nearly two decades. At the
same time, new classes of mental health therapies are advancing through
clinical trials and rigorous scientific evaluation. Several treatments
involving-controlled substances have received Breakthrough Therapy
designation from the U.S. Food and Drug Administration, which illus-
trates their potential to provide meaningful improvement over existing
options. A number of these clinical trials are being conducted at lead-
ing research institutions right here in New York.
For this reason, New York's Public Health Law must be modernized to
allow for immediate access to emerging mental health solutions following
their approval by the FDA and rescheduling by the U.S. Drug Enforcement
Administration. Consistent with the stated purpose of the New York State
Controlled Substances Act to "allow legitimate use of controlled
substances in health care," this bill addresses a critical gap in New
York law and ensures that if a compound, mixture or preparation that
contains a controlled substance is approved by the FDA and scheduled by
the DEA, patients in New York will have rapid access to these innovative
treatment options without delay. This refers only to compounds,
mixtures, or preparations approved by the FDA for legitimate use in
health care, not entire classes of substances.
As promising clinical research advances toward FDA review, New York must
be prepared for the next generation of mental health treatments. This
legislation modernizes state law to ensure timely patient access to
these emerging therapies, particularly for individuals, including veter-
ans, who have not benefited from existing options. As a national leader
in mental health, New York must be ready to meet this moment and support
innovation that can improve patient outcomes.
 
PRIOR LEGISLATIVE HISTORY:
New Bill
 
FISCAL IMPLICATION:
Yet to be determined if any
 
EFFECTIVE DATE:
This act shall take effect immediately.

Statutes affected:
S9852: 3306 public health law, 3307 public health law, 3307(5) public health law