S0003B0889A06072 PWK:EJH 03/14/16 #90 A06072
AMENDMENTS TO SENATE BILL NO. 3 (As amended by A05835)
Sponsor: REPRESENTATIVE MENTZER
Printer's No. 889
Amend Bill, page 1, lines 4 through 37; page 2, lines 1
through 51; page 3, lines 1 through 8 (A05835), by striking out
all of said lines on all of said pages and inserting
Statewide expanded access clinical trials for cannabinoids; and
requiring certain physicians to provide annual reports.
TABLE OF CONTENTS
Section 1. Short title.
Section 2. Legislative findings and intent.
Section 3. Definitions.
Section 4. Expanded access clinical trials.
Section 5. Requirements for cannabinoids.
Section 6. Duty to provide annual report.
Section 7. Construction.
Section 8. Effective date.
Amend Bill, page 3, lines 12 through 48; page 4 through 44,
lines 1 through 51; page 45, lines 1 through 6 (A05835), by
striking out all of said lines and inserting
Section 1. Short title.
This act shall be known and may be cited as the Therapeutic
Cannabinoid Research Act.
Section 2. Legislative findings and intent.
The General Assembly finds and declares that:
(1) Pennsylvania's citizens with severe or life-
threatening diseases or conditions may not be able to access
critical medications that are still in clinical trials.
(2) The Food and Drug Administration (FDA) has
established Expanded Access Programs to allow limited,
supervised access to such medications.
(3) While certain of its unique chemicals, called
cannabinoids, may become approved medicines, this does not
make marijuana itself a medicine.
(4) Marijuana contains at least 85 cannabinoids that can
be extracted from marijuana and purified, or synthesized in a
laboratory, and tested in animals in preclinical research to
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ensure that they are safe to administer to humans in clinical
trials.
(5) The FDA has approved several expanded access
investigational new drug (IND) applications that enable
investigators to utilize cannabinoids.
(6) The intent of this act is to increase the number of
expanded access IND applications at academic medical centers
in this Commonwealth so as to provide and further test the
medical uses of cannabinoids.
Section 3. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Academic medical center." A hospital that operates a
medical residency program for physicians and conducts research
that involves human subjects.
"Approved source." A provider which produces cannabinoids
that:
(1) Have been manufactured and tested in a facility
approved or certified by the Food and Drug Administration or
similar national regulatory agency in the United States or
another country.
(2) Have been tested in animals to demonstrate
preliminary effectiveness and to ensure that it is safe to
administer to humans.
"Investigator." An individual who actually conducts a
clinical investigation and under whose immediate direction a
drug is administered or dispensed to a subject.
"Physician." A person licensed to practice medicine in this
Commonwealth.
"Sponsor." A person, including an individual or
pharmaceutical company, governmental agency, academic
institution, private organization or other organization, who
takes responsibility for and initiates a clinical investigation.
"Sponsor-investigator." An individual who both initiates and
conducts an investigation and under whose immediate direction an
investigational drug is administered or dispensed.
Section 4. Expanded access clinical trials.
(a) Authorization.--Statewide investigational new drug
applications may be established in this Commonwealth, if
submitted by a sponsor or sponsor-investigator and approved by
the Food and Drug Administration, to conduct expanded access
clinical trials using cannabinoids.
(b) Physicians as sponsor-investigators or investigators.--A
physician practicing in an academic medical center in this
Commonwealth shall serve as the sponsor-investigator or
investigator for the clinical trials.
(c) Subinvestigators.--A physician, acting as a sponsor-
investigator or investigator, may include subinvestigators who
are physicians practicing in an academic medical center in this
Commonwealth.
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(d) Compliance with rules and regulations.--The sponsor,
sponsor-investigator or investigator, and all subinvestigators,
shall adhere to the rules and regulations established by the
relevant institutional review board for each participating
academic medical center and by the Food and Drug Administration,
Drug Enforcement Administration, National Institute on Drug
Abuse, Department of Health and the State Board of Pharmacy,
where applicable.
Section 5. Requirements for cannabinoids.
(a) General rule.--Expanded access clinical trials conducted
pursuant to a Statewide investigational new drug application
established pursuant to this act shall only utilize cannabinoids
that are:
(1) From an approved source.
(2) Authorized by the Food and Drug Administration to be
used for treatment of a condition specified in an
investigational new drug application.
(b) Source of cannabinoids.--The sponsor, sponsor-
investigator or investigator, and any subinvestigator, may
receive cannabinoids directly from an approved source or
authorized distributor for an approved source for use in the
expanded access clinical trials.
(c) Oversight and enforcement.--The ordering, receipt,
handling, storage and dispensing of cannabinoids pursuant to
this act shall be subject to oversight and enforcement by the
State Board of Pharmacy.
Section 6. Duty to provide annual report.
The sponsor or sponsor-investigator in the Statewide
investigational new drug application established pursuant to
this act shall annually provide a report on the results of the
expanded access clinical trials to the chairpersons of the
Committee on Public Health and Welfare of the Senate and
Committee on Health of the House of Representatives. The report
shall redact the names of patients and may redact the names of
physicians, if desired. The information in the report may be
derived from reports required by and submitted to the Food and
Drug Administration, if appropriate.
Section 7. Construction.
Nothing in this act shall be construed to authorize the
cultivating or processing of marijuana, cannabis or hemp by any
individual or entity in this Commonwealth for any purpose.
Section 8. Effective date.
This act shall take effect in 60 days.
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