[Congressional Record Volume 168, Number 124 (Tuesday, July 26, 2022)]
[House]
[Pages H7120-H7124]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
MEDICAL MARIJUANA AND CANNABIDIOL RESEARCH EXPANSION ACT
Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 8454) to expand research on cannabidiol and marijuana, and
for other purposes, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 8454
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Medical
Marijuana and Cannabidiol Research Expansion Act''.
(b) Table of Contents.--The table of contents for this Act
is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Definitions.
Sec. 3. Determination of budgetary effects.
TITLE I--REGISTRATIONS FOR MARIJUANA RESEARCH
Sec. 101. Marijuana research applications.
Sec. 102. Research protocols.
Sec. 103. Applications to manufacture marijuana for research.
Sec. 104. Adequate and uninterrupted supply.
Sec. 105. Security requirements.
Sec. 106. Prohibition against reinstating interdisciplinary review
process for non-NIH-funded researchers.
TITLE II--DEVELOPMENT OF FDA-APPROVED DRUGS USING CANNABIDIOL AND
MARIJUANA
Sec. 201. Medical research on cannabidiol.
Sec. 202. Registration for the commercial production and distribution
of Food and Drug Administration-approved drugs.
TITLE III--DOCTOR-PATIENT RELATIONSHIP
Sec. 301. Doctor-patient relationship.
TITLE IV--FEDERAL RESEARCH
Sec. 401. Federal research.
SEC. 2. DEFINITIONS.
(a) In General.--In this Act--
(1) the term ``appropriately registered'' means that an
individual or entity is registered under the Controlled
Substances Act (21 U.S.C. 801 et seq.) to engage in the type
of activity that is carried out by the individual or entity
with respect to a controlled substance on the schedule that
is applicable to cannabidiol or marijuana, as applicable;
(2) the term ``cannabidiol'' means--
(A) the substance, cannabidiol, as derived from marijuana
that has a delta-9-tetrahydrocannabinol level that is greater
than 0.3 percent; and
(B) the synthetic equivalent of the substance described in
subparagraph (A);
(3) the terms ``controlled substance'', ``dispense'',
``distribute'', ``manufacture'', ``marijuana'', and
``practitioner'' have the meanings given such terms in
section 102 of the Controlled Substances Act (21 U.S.C. 802),
as amended by this Act;
(4) the term ``covered institution of higher education''
means an institution of higher education (as defined in
section 101 of the Higher Education Act of 1965 (20 U.S.C.
1001)) that--
(A)(i) has highest or higher research activity, as defined
by the Carnegie Classification of Institutions of Higher
Education; or
(ii) is an accredited medical school or an accredited
school of osteopathic medicine; and
(B) is appropriately registered under the Controlled
Substances Act (21 U.S.C. 801 et seq.);
(5) the term ``drug'' has the meaning given the term in
section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(g)(1));
(6) the term ``medical research for drug development''
means medical research that is--
(A) a preclinical study or clinical investigation conducted
in accordance with section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i)) or otherwise permitted by
the Department of Health and Human Services to determine the
potential medical benefits of marijuana or cannabidiol as a
drug; and
(B) conducted by a covered institution of higher education,
practitioner, or manufacturer that is appropriately
registered under the Controlled Substances Act (21 U.S.C. 801
et seq.); and
(7) the term ``State'' means any State of the United
States, the District of Columbia, and any territory of the
United States.
(b) Updating Term.--Section 102(16) of the Controlled
Substances Act (21 U.S.C. 802(16)) is amended--
(1) in subparagraph (A), by striking ``the term `marihuana'
means'' and inserting ``the terms `marihuana' and `marijuana'
mean''; and
(2) in subparagraph (B), by striking ``The term `marihuana'
does not'' and inserting ``The terms `marihuana' and
`marijuana' do not''.
SEC. 3. DETERMINATION OF BUDGETARY EFFECTS.
The budgetary effects of this Act, for the purpose of
complying with the Statutory Pay-As-You-Go Act of 2010, shall
be determined by reference to the latest statement titled
``Budgetary Effects of PAYGO Legislation'' for this Act,
submitted for printing in the Congressional Record by the
Chairman of the House Budget Committee, provided that such
statement has been submitted prior to the vote on passage.
TITLE I--REGISTRATIONS FOR MARIJUANA RESEARCH
SEC. 101. MARIJUANA RESEARCH APPLICATIONS.
Section 303(f) of the Controlled Substances Act (21 U.S.C.
823(f)) is amended--
(1) by redesignating paragraphs (1) through (5) as
subparagraphs (A) through (E), respectively;
(2) by striking ``(f) The Attorney General'' and inserting
``(f)(1) The Attorney General'';
(3) by striking ``Registration applications'' and inserting
the following:
``(2)(A) Registration applications'';
(4) by striking ``Article 7'' and inserting the following:
``(3) Article 7''; and
(5) by inserting after paragraph (2)(A), as so designated,
the following:
``(B)(i) The Attorney General shall register a practitioner
to conduct research with marijuana (including any derivative,
extract, preparation, and compound thereof) if--
``(I) the applicant's research protocol has been reviewed
and allowed--
``(aa) by the Secretary of Health and Human Services under
section 505(i) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(i));
``(bb) by the National Institutes of Health or another
Federal agency that funds scientific research; or
``(cc) pursuant to sections 1301.18 and 1301.32 of title
21, Code of Federal Regulations, or any successors thereto;
and
``(II) the applicant has demonstrated to the Attorney
General that there are effective procedures in place to
adequately safeguard against diversion of the controlled
substance for legitimate medical or scientific use pursuant
to section 105 of the Medical Marijuana and Cannabidiol
Research Expansion Act, including demonstrating that the
security measures are adequate for storing the quantity of
marijuana the applicant would be authorized to possess.
``(ii) The Attorney General may deny an application for
registration under this subparagraph only if the Attorney
General determines that the issuance of the registration
would be inconsistent with the public interest. In
determining the public interest, the Attorney General shall
consider the factors listed in--
``(I) subparagraphs (B) through (E) of paragraph (1); and
``(II) subparagraph (A) of paragraph (1), if the applicable
State requires practitioners conducting research to register
with a board or authority described in such subparagraph (A).
``(iii)(I) Not later than 60 days after the date on which
the Attorney General receives a complete application for
registration under this subparagraph, the Attorney General
shall--
``(aa) approve the application; or
``(bb) request supplemental information.
``(II) For purposes of subclause (I), an application shall
be deemed complete when the applicant has submitted
documentation showing that the requirements under clause (i)
are satisfied.
``(iv) Not later than 30 days after the date on which the
Attorney General receives supplemental information as
described in clause (iii)(I)(bb) in connection with an
application described in this subparagraph, the Attorney
General shall approve or deny the application.
``(v) If an application described in this subparagraph is
denied, the Attorney General shall provide a written
explanation of the basis of denial to the applicant.''.
SEC. 102. RESEARCH PROTOCOLS.
(a) In General.--Paragraph (2)(B) of section 303(f) of the
Controlled Substances Act (21 U.S.C. 823(f)), as added by
section 101 of this Act, is further amended by adding at the
end the following:
``(vi)(I) If the Attorney General grants an application for
registration under clause (i),
[[Page H7121]]
the registrant may amend or supplement the research protocol
without notification to, or review by, the Drug Enforcement
Administration if the registrant does not change--
``(aa) the quantity or type of marijuana or cannabidiol
(including any derivative, extract, preparation, and compound
thereof);
``(bb) the source of such marijuana or cannabidiol; or
``(cc) the conditions under which such marijuana or
cannabidiol is stored, tracked, or administered.
``(II)(aa) If a registrant under clause (i) seeks to change
the type of marijuana or cannabidiol (including any
derivative, extract, preparation, and compound thereof), the
source of such marijuana or cannabidiol, or the conditions
under which such marijuana or cannabidiol is stored, tracked,
or administered, the registrant shall notify the Attorney
General via registered mail, or an electronic means permitted
by the Attorney General, not later than 30 days before
implementing an amended or supplemental research protocol.
``(bb) A registrant may proceed with an amended or
supplemental research protocol described in item (aa) if the
Attorney General does not explicitly object during the 30-day
period beginning on the date on which the Attorney General
receives the notice under item (aa).
``(cc) The Attorney General may only object to an amended
or supplemental research protocol under this subclause if
additional security measures are needed to safeguard against
diversion or abuse.
``(dd) If a registrant under clause (i) seeks to address
additional security measures identified by the Attorney
General under item (cc), the registrant shall notify the
Attorney General via registered mail, or an electronic means
permitted by the Attorney General, not later than 30 days
before implementing an amended or supplemental research
protocol.
``(ee) A registrant may proceed with an amended or
supplemental research protocol described in item (dd) if the
Attorney General does not explicitly object during the 30-day
period beginning on the date on which the Attorney General
receives the notice under item (dd).
``(III)(aa) If a registrant under clause (i) seeks to
change the quantity of marijuana needed for research and the
change in quantity does not impact the factors described in
item (bb) or (cc) of subclause (I) of this clause, the
registrant shall notify the Attorney General via registered
mail or using an electronic means permitted by the Attorney
General.
``(bb) A notification under item (aa) shall include--
``(AA) the Drug Enforcement Administration registration
number of the registrant;
``(BB) the quantity of marijuana or cannabidiol already
obtained;
``(CC) the quantity of additional marijuana or cannabidiol
needed to complete the research; and
``(DD) an attestation that the change in quantity does not
impact the source of the marijuana or cannabidiol or the
conditions under which the marijuana or cannabidiol is
stored, tracked, or administered.
``(cc) The Attorney General shall ensure that--
``(AA) any registered mail return receipt with respect to a
notification under item (aa) is submitted for delivery to the
registrant providing the notification not later than 3 days
after receipt of the notification by the Attorney General;
and
``(BB) notice of receipt of a notification using an
electronic means permitted under item (aa) is provided to the
registrant providing the notification not later than 3 days
after receipt of the notification by the Attorney General.
``(dd)(AA) On and after the date described in subitem (BB),
a registrant that submits a notification in accordance with
item (aa) may proceed with the research as if the change in
quantity has been approved on such date, unless the Attorney
General notifies the registrant of an objection described in
item (ee).
``(BB) The date described in this subitem is the date on
which a registrant submitting a notification under item (aa)
receives the registered mail return receipt with respect to
the notification or the date on which the registrant receives
notice that the notification using an electronic means
permitted under item (aa) was received by the Attorney
General, as the case may be.
``(ee) A notification submitted under item (aa) shall be
deemed to be approved unless the Attorney General, not later
than 10 days after receiving the notification, explicitly
objects based on a finding that the change in quantity--
``(AA) does impact the source of the marijuana or
cannabidiol or the conditions under which the marijuana or
cannabidiol is stored, tracked, or administered; or
``(BB) necessitates that the registrant implement
additional security measures to safeguard against diversion
or abuse.
``(IV) Nothing in this clause shall limit the authority of
the Secretary of Health and Human Services over requirements
related to research protocols, including changes in--
``(aa) the method of administration of marijuana or
cannabidiol;
``(bb) the dosing of marijuana or cannabidiol; and
``(cc) the number of individuals or patients involved in
research.''.
(b) Regulations.--Not later than 1 year after the date of
enactment of this Act, the Attorney General shall promulgate
regulations to carry out the amendment made by this section.
SEC. 103. APPLICATIONS TO MANUFACTURE MARIJUANA FOR RESEARCH.
(a) In General.--Section 303 of the Controlled Substances
Act (21 U.S.C. 823), as amended by sections 101 and 102 of
this Act, is further amended--
(1) by redesignating subsections (c) through (k) as
subsections (d) through (l), respectively;
(2) by inserting after subsection (b) the following:
``(c)(1)(A) As it relates to applications to manufacture
marijuana for research purposes, when the Attorney General
places a notice in the Federal Register to increase the
number of entities registered under this Act to manufacture
marijuana to supply appropriately registered researchers in
the United States, the Attorney General shall, not later than
60 days after the date on which the Attorney General receives
a completed application--
``(i) approve the application; or
``(ii) request supplemental information.
``(B) For purposes of subparagraph (A), an application
shall be deemed complete when the applicant has submitted
documentation showing each of the following:
``(i) The requirements designated in the notice in the
Federal Register are satisfied.
``(ii) The requirements under this Act are satisfied.
``(iii) The applicant will limit the transfer and sale of
any marijuana manufactured under this subsection--
``(I) to researchers who are registered under this Act to
conduct research with controlled substances in schedule I;
and
``(II) for purposes of use in preclinical research or in a
clinical investigation pursuant to an investigational new
drug exemption under 505(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(i)).
``(iv) The applicant will transfer or sell any marijuana
manufactured under this subsection only with prior, written
consent for the transfer or sale by the Attorney General.
``(v) The applicant has completed the application and
review process under subsection (a) for the bulk manufacture
of controlled substances in schedule I.
``(vi) The applicant has established and begun operation of
a process for storage and handling of controlled substances
in schedule I, including for inventory control and monitoring
security in accordance with section 105 of the Medical
Marijuana and Cannabidiol Research Expansion Act.
``(vii) The applicant is licensed by each State in which
the applicant will conduct operations under this subsection,
to manufacture marijuana, if that State requires such a
license.
``(C) Not later than 30 days after the date on which the
Attorney General receives supplemental information requested
under subparagraph (A)(ii) with respect to an application,
the Attorney General shall approve or deny the application.
``(2) If an application described in this subsection is
denied, the Attorney General shall provide a written
explanation of the basis of denial to the applicant.'';
(3) in subsection (h)(2), as so redesignated, by striking
``subsection (f)'' each place it appears and inserting
``subsection (g)'';
(4) in subsection (j)(1), as so redesignated, by striking
``subsection (d)'' and inserting ``subsection (e)''; and
(5) in subsection (k), as so redesignated, by striking
``subsection (f)'' each place it appears and inserting
``subsection (g)''.
(b) Technical and Conforming Amendments.--
(1) The Controlled Substances Act (21 U.S.C. 801 et seq.)
is amended--
(A) in section 102 (21 U.S.C. 802)--
(i) in paragraph (52)(B)--
(I) by striking ``303(f)'' each place it appears and
inserting ``303(g)''; and
(II) in clause (i), by striking ``(d), or (e)'' and
inserting ``(e), or (f)''; and
(ii) in paragraph (54), by striking ``303(f)'' each place
it appears and inserting ``303(g)'';
(B) in section 302(g)(5)(A)(iii)(I)(bb) (21 U.S.C.
822(g)(5)(A)(iii)(I)(bb)), by striking ``303(f)'' and
inserting ``303(g)'';
(C) in section 304 (21 U.S.C. 824), by striking
``303(g)(1)'' each place it appears and inserting
``303(h)(1)'';
(D) in section 307(d)(2) (21 U.S.C. 827(d)(2)), by striking
``303(f)'' and inserting ``303(g)'';
(E) in section 309A(a)(2) (21 U.S.C. 829a(a)(2)), in the
matter preceding subparagraph (A), by striking ``303(g)(2)''
and inserting ``303(h)(2)'';
(F) in section 311(h) (21 U.S.C. 831(h)), by striking
``303(f)'' each place it appears and inserting ``303(g)'';
(G) in section 401(h)(2) (21 U.S.C. 841(h)(2)), by striking
``303(f)'' each place it appears and inserting ``303(g)'';
(H) in section 403(c)(2)(B) (21 U.S.C. 843(c)(2)(B)), by
striking ``303(f)'' and inserting ``303(g)''; and
(I) in section 512(c)(1) (21 U.S.C. 882(c)(1)) by striking
``303(f)'' and inserting ``303(g)''.
(2) Section 1008(c) of the Controlled Substances Import and
Export Act (21 U.S.C. 958(c)) is amended--
(A) in paragraph (1), by striking ``303(d)'' and inserting
``303(e)''; and
(B) in paragraph (2)(B), by striking ``303(h)'' and
inserting ``303(i)''.
(3) Title V of the Public Health Service Act (42 U.S.C.
290aa et seq.) is amended--
(A) in section 520E-4(c) (42 U.S.C. 290bb-36d(c)), by
striking ``303(g)(2)(B)'' and inserting ``303(h)(2)(B)''; and
[[Page H7122]]
(B) in section 544(a)(3) (42 U.S.C. 290dd-3(a)(3)), by
striking ``303(g)'' and inserting ``303(h)''.
(4) Title XVIII of the Social Security Act (42 U.S.C. 1395
et seq.) is amended--
(A) in section 1833(bb)(3)(B) (42 U.S.C. 1395l(bb)(3)(B)),
by striking ``303(g)'' and inserting ``303(h)'';
(B) in section 1834(o)(3)(C)(ii) (42 U.S.C.
1395m(o)(3)(C)(ii)), by striking ``303(g)'' and inserting
``303(h)''; and
(C) in section 1866F(c)(3)(C) (42 U.S.C. 1395cc-
6(c)(3)(C)), by striking ``303(g)'' and inserting ``303(h)''.
(5) Section 1903(aa)(2)(C)(ii) of the Social Security Act
(42 U.S.C. 1396b(aa)(2)(C)(ii)) is amended by striking
``303(g)'' each place it appears and inserting ``303(h)''.
SEC. 104. ADEQUATE AND UNINTERRUPTED SUPPLY.
(a) In General.--On an annual basis, the Attorney General,
in consultation with the Secretary of Health and Human
Services, shall assess whether there is an adequate and
uninterrupted supply of marijuana, including of specific
strains, for research purposes.
(b) Report to Congress.--If the Attorney General, in
consultation with the Secretary of Health and Human Services,
determines there is an inadequate or interrupted supply of
marijuana, including of specific strains for research
purposes, the Attorney General shall report to Congress
within 60 days of the determination on at least--
(1) the factors contributing to the inadequate or
interrupted supply of marijuana;
(2) expected impacts of the inadequate or interrupted
supply on ongoing research protocols; and
(3) specific steps the Attorney General will take to
restore an adequate and uninterrupted supply of marijuana,
including of specific strains, for research purposes.
SEC. 105. SECURITY REQUIREMENTS.
(a) In General.--An individual or entity engaged in
researching marijuana or its components shall store it in a
securely locked, substantially constructed cabinet.
(b) Requirements for Other Measures.--Any other security
measures required by the Attorney General to safeguard
against diversion shall be consistent with those required for
practitioners conducting research on other controlled
substances in schedules I and II in section 202(c) of the
Controlled Substances Act (21 U.S.C. 812(c)) that have a
similar risk of diversion and abuse.
SEC. 106. PROHIBITION AGAINST REINSTATING INTERDISCIPLINARY
REVIEW PROCESS FOR NON-NIH-FUNDED RESEARCHERS.
The Secretary of Health and Human Services may not--
(1) reinstate the Public Health Service interdisciplinary
review process described in the guidance entitled ``Guidance
on Procedures for the Provision of Marijuana for Medical
Research'' (issued on May 21, 1999); or
(2) require another review of scientific protocols that is
applicable only to research on marijuana or its components.
TITLE II--DEVELOPMENT OF FDA-APPROVED DRUGS USING CANNABIDIOL AND
MARIJUANA
SEC. 201. MEDICAL RESEARCH ON CANNABIDIOL.
Notwithstanding any provision of the Controlled Substances
Act (21 U.S.C. 801 et seq.), the Safe and Drug-Free Schools
and Communities Act (20 U.S.C. 7101 et seq.), chapter 81 of
title 41, United States Code, or any other Federal law, an
appropriately registered covered institution of higher
education, practitioner, or manufacturer may manufacture,
distribute, dispense, or possess marijuana or cannabidiol if
the marijuana or cannabidiol is manufactured, distributed,
dispensed, or possessed, respectively, for purposes of
medical research for drug development or subsequent
commercial production in accordance with section 202.
SEC. 202. REGISTRATION FOR THE COMMERCIAL PRODUCTION AND
DISTRIBUTION OF FOOD AND DRUG ADMINISTRATION-
APPROVED DRUGS.
The Attorney General shall register an applicant to
manufacture or distribute cannabidiol or marijuana for the
purpose of commercial production of a drug containing or
derived from marijuana that is approved by the Secretary of
Health and Human Services under section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355), in accordance
with the applicable requirements under subsection (a) or (b)
of section 303 of the Controlled Substances Act (21 U.S.C.
823).
TITLE III--DOCTOR-PATIENT RELATIONSHIP
SEC. 301. DOCTOR-PATIENT RELATIONSHIP.
It shall not be a violation of the Controlled Substances
Act (21 U.S.C. 801 et seq.) for a State-licensed physician to
discuss--
(1) the currently known potential harms and benefits of
marijuana derivatives, including cannabidiol, as a treatment
with the legal guardian of the patient of the physician if
the patient is a child; or
(2) the currently known potential harms and benefits of
marijuana and marijuana derivatives, including cannabidiol,
as a treatment with the patient or the legal guardian of the
patient of the physician if the patient is a legal adult.
TITLE IV--FEDERAL RESEARCH
SEC. 401. FEDERAL RESEARCH.
(a) In General.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services, in coordination with the Director of the National
Institutes of Health and the heads of other relevant Federal
agencies, shall submit to the Caucus on International
Narcotics Control, the Committee on the Judiciary, and the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce and the
Committee on the Judiciary of the House of Representatives a
report on--
(1) the potential therapeutic effects of cannabidiol or
marijuana on serious medical conditions, including
intractable epilepsy;
(2) the potential effects of marijuana, including--
(A) the effect of increasing delta-9-tetrahydrocannabinol
levels on the human body and developing adolescent brains;
and
(B) the effect of various delta-9-tetrahydrocannabinol
levels on cognitive abilities, such as those that are
required to operate motor vehicles or other heavy equipment;
and
(3) the barriers associated with researching marijuana or
cannabidiol in States that have legalized the use of such
substances, which shall include--
(A) recommendations as to how such barriers might be
overcome, including whether public-private partnerships or
Federal-State research partnerships may or should be
implemented to provide researchers with access to additional
strains of marijuana and cannabidiol; and
(B) recommendations as to what safeguards must be in place
to verify--
(i) the levels of tetrahydrocannabinol, cannabidiol, or
other cannabinoids contained in products obtained from such
States is accurate; and
(ii) that such products do not contain harmful or toxic
components.
(b) Activities.--To the extent practicable, the Secretary
of Health and Human Services, either directly or through
awarding grants, contacts, or cooperative agreements, shall
expand and coordinate the activities of the National
Institutes of Health and other relevant Federal agencies to
better determine the effects of cannabidiol and marijuana, as
outlined in the report submitted under paragraphs (1) and (2)
of subsection (a).
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New
Jersey (Mr. Pallone) and the gentleman from Georgia (Mr. Carter) each
will control 20 minutes.
The Chair recognizes the gentleman from New Jersey.
General Leave
Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and include extraneous material on H.R. 8454.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from New Jersey?
There was no objection.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise in support of H.R. 8454, the Medical Marijuana
and Cannabidiol Research Expansion Act, legislation that would expand
comprehensive cannabis research.
In March, the Senate passed S. 253, the Cannabidiol and Marihuana
Research Expansion Act. In April, the House considered and passed H.R.
5657, the Medical Marijuana Research Act, which also passed with strong
bipartisan support last Congress.
The bill before us today, H.R. 8454, represents a bipartisan,
bicameral agreement that resolves the differences between both bills
and brings us to a historic, overdue moment for Congress.
The consumption of marijuana and marijuana-derived CBD for medical
use is approved and regulated in 37 States, the District of Columbia,
Guam, Puerto Rico, and the U.S. Virgin Islands. This translates to tens
of millions of Americans consuming marijuana every year. Yet, we still
do not have a comprehensive body of research on the safety or
therapeutic effects or benefits of marijuana products.
Because of its status as a schedule I substance, research on
marijuana has been regulated in a restrictive, time-consuming way, and
the existing research is not representative of the products that are
currently available to many Americans.
H.R. 8454 streamlines the registration process for conducting
research on marijuana and manufacturing marijuana products for research
purposes and drug development. The bill maintains the appropriate
oversight and control by the Department of Health and Human Services
and the Drug Enforcement Administration and requires both applicants
and regulators to adhere to clear protocols and timelines.
The bill requires HHS and DEA to respond to registration applicants
in a timely manner and requires a regular assessment to confirm an
adequate supply of marijuana, including specific
[[Page H7123]]
strains, for medical research. This ensures that the marijuana being
provided for medical research appropriately reflects the strains and
THC content in millions of products across the country.
Mr. Speaker, this bill also clarifies that doctors can discuss with
patients the potential harms and benefits of marijuana as a medical
treatment.
Finally, H.R. 8454 requires HHS to submit a report to Congress on the
potential therapeutic effects of marijuana and CBD for serious medical
conditions, effects on the developing human brain and body, and
existing barriers to research.
Mr. Speaker, I thank Representatives Blumenauer, Harris, Holmes
Norton, Dingell, Cohen, Griffith, Lee, and Case for their leadership on
this issue. I urge my colleagues to support the bill and look forward
to the Senate acting expeditiously on our agreement to expand
comprehensive cannabis research while protecting public health and
safety.
Mr. Speaker, I reserve the balance of my time.
Mr. CARTER of Georgia. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, I rise today to speak in favor of H.R. 8454, the Medical
Marijuana and Cannabidiol Research Expansion Act. This bill is a
revised version of H.R. 5657, Medical Marijuana Research Act, which was
led by Representatives Harris and Blumenauer, and overwhelmingly passed
the House in April.
The text of H.R. 8454 that we are considering today is largely
similar to H.R. 5657, but it is consensus language that was agreed to
through bipartisan negotiations with the Senate. I am pleased we were
able to get the language to a good place.
Marijuana is a schedule I controlled substance under the Controlled
Substances Act. Research on these substances must be conducted in
accordance with the Controlled Substances Act and requires the Drug
Enforcement Administration approve research protocol.
If a researcher desires to make changes to an approved project, the
researcher must submit a request to do so, which is then reviewed and
must be approved by both the DEA and the FDA.
In addition to the extensive regulatory hurdles that researchers
face, the actual supply of research-grade marijuana is relatively
limited. The supply is subject to the single convention on narcotic
drugs, which imposes certain obligations related to governmental
oversight of its cultivation.
While the DEA and the National Institute on Drug Abuse have taken
some steps to increase the number of domestic manufacturers of
research-grade marijuana, more could be done in this space. The Medical
Marijuana Research Expansion Act improves the Federal research
landscape by streamlining both the research and manufacturing
registration processes.
This is critical to better understand the potential benefits and
possible risks associated with marijuana use, as researchers must be
able to study actual products that are currently used by consumers for
both medical and recreational use. These data are long overdue, as
policy decisions have far outpaced the science.
States that have fully legalized marijuana have done so in a relative
information vacuum with less understanding of what it is and what it
does than virtually any nutritional supplement currently on the market,
and with far less information than they have on legal substances that
are easily abused, such as alcohol or tobacco.
Until we make it easier to conduct the research, making fully
informed policy decisions will remain challenging. Even rescheduling
the substance administratively will necessitate robust data on
potential medical use.
Recent evaluations conducted separately by the FDA and the National
Academies of Sciences, Engineering, and Medicine have both illustrated
the challenges of meeting the required standard of evidence for
demonstrating effective medical use. Both studies concluded that lack
of research was a significant factor in denying rescheduling petitions
in the past.
If Congress does not act, we will continue to have limited ability to
study these products in clinical trial settings. This commonsense
solution will better our understanding of marijuana through legal,
Federally sanctioned and scientifically valid research on this
substance.
Mr. Speaker, I thank Representatives Blumenauer and Harris, along
with Chairman Pallone, for working together on this legislation, and I
reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I have no additional speakers, and I
reserve the balance of my time.
Mr. CARTER of Georgia. Mr. Speaker, I yield such time as he may
consume to the gentleman from Maryland (Mr. Harris), one of the leaders
on this important subject.
Mr. HARRIS. Mr. Speaker, the chairman of the committee got it right,
this is historic. This bill is overdue, bipartisan, and bicameral, as
it should be.
Today, I rise in support of H.R. 8454, the Medical Marijuana and
Cannabidiol Research Expansion Act.
Representative Blumenauer and I have jointly cosponsored this bill
for four Congresses. Talk about overdue. Although we disagree about
recreational marijuana--he supports it; I oppose it--we both concur
that in regard to medical marijuana, we need to do the rigorous
research to answer the questions.
As a physician, I realize that if we are going to have marijuana
legal in over three dozen States for medical uses, we really ought to
be able to do the research on it to see what it can and can't be used
for. Many claims are made about it--some are legitimate, some will be
found to be illegitimate--but the American public deserves to know
whether medical marijuana and cannabidiol work for those claims that
are being made.
This bill makes it easier to do the necessary, rigorous medical
research just like is done for any other drug that has a claim of
efficacy in this country. The American public deserves to know what
medical marijuana is useful for, because for anyone with those
conditions where it is found to be useful, it could be a godsend. But
for other conditions where the claims won't be found to be valid with
rigorous research, it would be found to be ineffective, and that would
help protect American patients as well.
This would modernize our research methods, bringing medical marijuana
up to the scientific standards we use for every other type of
medication that is sold as a drug in this country.
Mr. Speaker, I urge support of this bill.
Mr. PALLONE. Mr. Speaker, I reserve the balance of my time.
Mr. CARTER of Georgia. Mr. Speaker, I yield such time as he may
consume to the gentleman from Virginia (Mr. Griffith).
Mr. GRIFFITH. Mr. Speaker, I thank my friend, and leader of the
committee, Frank Pallone.
H.R. 8454 is an important bill, and it is interesting to hear the
conversation here on the floor. Mr. Carter was talking about the
history that you couldn't get marijuana rescheduled because they didn't
have enough research, and you can't get the research because it is
scheduled as a schedule I drug, so we have been trapped in this vortex
where we can't get the information.
I, too, am against recreational marijuana. But for medical marijuana,
I think it has a great benefit. For years, we have been in this trap
where you couldn't do sufficient research, therefore you couldn't
reschedule it. It is crazy. We are going to fix it here today.
My belief is that medical marijuana can be beneficial when used in a
proper setting. Despite the increasing use of cannabis products around
the country, there have been very few legitimate peer-reviewed studies
to determine the effect of cannabis on the body.
We know it does some good anecdotally for patients with juvenile
seizures. What we don't know is how much THC has to be in the
cannabidiol to make it effective. This is what we need research for.
{time} 1700
This bill allows us to obtain approval to conduct cannabis research
and obtain quality product, not just one strain out of Mississippi, but
multiple products, quality products, monitored by the Government, to
make sure it is not being misused, to be used in this research.
[[Page H7124]]
It encourages research by improving and streamlining the registration
process for marijuana. It also ensures the availability of verified
cannabis products necessary for legitimate research by allowing
approved institutions of higher education, practitioners, and
manufacturers to manufacture and distribute marijuana for the purpose
of conducting research.
As someone who has advocated for this legislation for years, I
appreciate the work that has been done to get us here today.
Whatever position you may have on marijuana use, you need to know
that this bill will allow us to come together and support more
scientific research so that we can make informed decisions as we move
forward as legislators.
I have to tell you, being here live as a legislator is also
important, because the genesis of this bill was several conversations
that took place on the floor of this House when people who disagree on
the underlying issue would argue about what research showed. It finally
became clear to Representative Blumenauer, to Representative Harris, to
myself, and to others, that we had to have more research in order to
get the right answers for the American people.
Mr. Speaker, I urge everyone to support H.R. 8454.
Mr. CARTER of Georgia. Mr. Speaker, I would encourage my colleagues
to support this legislation, and I yield back the balance of my time.
Mr. PALLONE. Mr. Speaker, again, I think this is a great way of
dealing with this issue overall and getting the Senate on board.
Mr. Speaker, I urge my colleagues to support this important
legislation, and I yield back the balance of my time.
Ms. ESHOO. Mr. Speaker, I rise in support of H.R. 8454, the Medical
Marijuana and Cannabidiol Research Expansion Act. I advanced a
precursor to this bipartisan bill through my Health Subcommittee and
I'm proud to support it on the Floor today.
According to the Department of Health and Human Services National
Survey on Drug Use, over 48 million Americans reported using cannabis
in the past year. Thirty-seven states now allow the medicinal use of
cannabis and 19 states and the District of Columbia have legalized
cannabis for adult use.
But state laws and federal policy are a thousand miles apart. As more
states allow cannabis, the federal government still strictly controls
and prohibits it, even restricting legitimate medical research.
The Medical Marijuana Research Act addresses these restrictions on
research and alleviates a burdensome, out-of-date process for
scientific researchers. First, it creates a new, less cumbersome
registration process specifically for marijuana, reducing approval wait
times and costly security measures. Second, this bill makes it easier
for researchers to obtain the cannabis they need for their studies
through reforms in production and distribution regulations.
Under this bill scientists will no longer be forced to wait more than
a year to become federally-approved to conduct cannabis research. They
will also not be forced to use the cannabis grown by a government-
authorized farm at the University of Mississippi. This cannabis lacks
the properties and potency of commercially-available cannabis and leads
to inadequate research.
This is a commonsense bill that will update federal policy to advance
research on cannabis and its compounds. I urge my colleagues to support
this bill.
Mr. BLUMENAUER. Mr. Speaker, today I will vote to pass the Medical
Marijuana and Cannabidiol Research Expansion Act. This legislation
would remove barriers for research into cannabis and facilitate access
to an increased supply of cannabis for research purposes.
The cannabis laws in this country are broken, including our laws that
govern cannabis research. Because cannabis is a Schedule I substance,
researchers must jump through hoops and comply with onerous
requirements just to do basic research on the medical potential of the
plant.
The Medical Marijuana and Cannabidiol Research Expansion Act amends
the Controlled Substances Act to streamline the registration process
and expands opportunity for our researchers to investigate the
potential and impacts of cannabis.
My partners in the House and Senate and I worked closely with experts
in Congress and the Department of Health and Human Services (HHS) to
ensure this legislation will expand cannabis research, not restrict it.
Specifically, the use of ``practitioners'' includes ``NIH-funded
researchers,'' according to feedback from HHS. This ensures that this
legislation will not restrict researchers already considered entities
eligible to conduct research under the Controlled Substances Act. H.R.
8454 is designed to streamline and broaden access to researching
marijuana.
Enacting this legislation will be an important step forward in making
the federal government a real partner in the path forward on cannabis.
In addition to this legislation, we must continue to advance banking
access for cannabis businesses; prioritize expungements, clemencies,
and resentencing for cannabis convictions; make robust investments in
cannabis research; develop accurate tests for impairment; ensure our
veterans can access medical cannabis; and invest in communities
targeted in the failed war on drugs.
The Medical Marijuana and Cannabidiol Research Expansion Act
demonstrates the power of good faith bipartisan engagement on cannabis
policy and the opportunity of this moment to enact laws our communities
need.
I look forward to working with Senators Dianne Feinstein, Brian
Schatz, and Chuck Grassley and my co-lead Representative Andy Harris to
enact this legislation and expand our Nation's cannabis research
capabilities.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from New Jersey (Mr. Pallone) that the House suspend the
rules and pass the bill, H.R. 8454, as amended.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds
being in the affirmative, the ayes have it.
Mr. CLOUD. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further
proceedings on this motion will be postponed.
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