Congressional Record, Volume 166 Issue 208 (Wednesday, December 9, 2020)

[Congressional Record Volume 166, Number 208 (Wednesday, December 9, 2020)]
[House]
[Pages H7076-H7083]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

MEDICAL MARIJUANA RESEARCH ACT

Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 3797) to amend the Controlled Substances Act to make
marijuana accessible for use by qualified marijuana researchers for
medical purposes, and for other purposes, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:

H.R. 3797

Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Medical Marijuana Research
Act''.

SEC. 2. FACILITATING MARIJUANA RESEARCH.

(a) Production and Supply.--The Secretary of Health and
Human Services--
(1) until the date on which the Secretary determines that
manufacturers and distributors (other than the Federal
Government) can ensure a sufficient supply of marijuana (as
defined in section 102 of the Controlled Substances Act (21
U.S.C. 802), as amended by section 8) intended for research
by qualified marijuana researchers registered pursuant to
paragraph (3) of section 303(f) of the Controlled Substances
Act (21 U.S.C. 823(f)), as added by section 3, shall--
(A) continue, through grants, contracts, or cooperative
agreements, to produce marijuana through the National
Institute on Drug Abuse Drug Supply Program;
(B) not later than one year after the date of enactment of
this Act, act jointly with the Attorney General of the United
States to establish and implement a specialized process for
manufacturers and distributors, notwithstanding the
registration requirements of section 303 of such Act (21
U.S.C. 823), to supply qualified marijuana researchers with
marijuana products--
(i) available through State-authorized marijuana programs;
and
(ii) consistent with the guidance issued under subsection
(c); and
(C) not later than 60 days after the date of enactment of
this Act, jointly convene with the Attorney General a meeting
to initiate the development of the specialized process
described in subparagraph (B); and
(2) beyond the date specified in paragraph (1), may, at the
Secretary's discretion, continue--
(A) through grants, contracts, or cooperative agreements,
to so produce marijuana; and
(B) to implement such specialized process.
(b) Requirement to Verify Registration.--Before supplying
marijuana to any person through the National Institute on
Drug Abuse Drug Supply Program or through implementation of
the specialized process established under subsection
(a)(1)(B), the Secretary of Health and Human Services shall--
(1) require the person to submit documentation
demonstrating that the person is a qualified marijuana
researcher seeking to conduct research pursuant to section
303(f)(3) of the Controlled Substances Act, as added by
subsection (d) of this section, or a manufacturer duly
registered under section 303(l) of the Controlled Substances
Act, as added by section 3 of this Act; and
(2) not later than 60 days after receipt of such
documentation, review such documentation and verify that the
marijuana will be used for such research (and for no other
purpose authorized pursuant to this Act or the amendments
made by this Act).
(c) Guidance on Use of State-authorized Marijuana
Programs.--Not later than 180 days after the date of the
enactment of this Act, the Secretary of Health and Human
Services shall issue guidance related to marijuana from
State-authorized marijuana programs for research.
(d) Research.--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) Registration applications'';
(4) in paragraph (2), as so designated, by striking
``schedule I'' each place that term appears and inserting
``schedule I, except marijuana,'';
(5) by striking ``Article 7'' and inserting the following:
``(4) Article 7''; and
(6) by inserting before paragraph (4), as so designated,
the following:
``(3)(A) The Attorney General shall register the applicant
to conduct research with marijuana if--
``(i) the applicant is authorized to dispense, or conduct
research with respect to, controlled substances in schedule
I, II, III, IV, or V;
``(ii) the applicant is compliant with, and authorized to
conduct the activities described in clause (i) under, the
laws of the State in which the applicant practices; and
``(iii) in the case of an applicant pursuing clinical
research, the applicant's clinical research protocol has been
reviewed and authorized to proceed by the Secretary under
section 505(i) of the Federal Food, Drug, and Cosmetic Act.
``(B) An applicant registered under subparagraph (A) shall
be referred to in this section as a `qualified marijuana
researcher'.
``(C)(i) Not later than 60 days after the date on which the
Attorney General receives a complete application for
registration under this paragraph, the Attorney General shall
approve or deny the application.

[[Page H7077]]

``(ii) For purposes of clause (i), an application shall be
deemed complete when the applicant has submitted
documentation showing that the requirements under
subparagraph (A) are satisfied.
``(iii) In the case of a denial under clause (i), the
Attorney General shall provide a written explanation of the
basis for the denial.
``(D) The Attorney General shall grant an application for
registration under this paragraph unless the Attorney General
determines that the issuance of the registration would be
inconsistent with the public interest. In determining the
public interest, the following factors shall be considered:
``(i) The applicant's experience in dispensing, or
conducting research with respect to, controlled substances.
``(ii) The applicant's conviction record under Federal or
State laws relating to the manufacture, distribution, or
dispensing of controlled substances.
``(iii) Compliance with applicable State or local laws
relating to controlled substance misuse or diversion.
``(iv) Such other conduct which may threaten the public
health and safety.
``(E)(i) A qualified marijuana researcher shall store
marijuana to be used in research in a securely locked,
substantially constructed cabinet.
``(ii) Except as provided in clause (i), any security
measures required by the Attorney General for applicants
conducting research with marijuana pursuant to a registration
under this paragraph shall be consistent with the security
measures for applicants conducting research on other
controlled substances in schedule II that have a similar risk
of diversion and abuse.
``(F)(i) If the Attorney General grants an application for
registration under this paragraph, the applicant may amend or
supplement the research protocol and proceed with the
research under such amended or supplemented protocol, without
additional review or approval by the Attorney General or the
Secretary of Health and Human Services if the applicant does
not change the type of marijuana, the source of the
marijuana, or the conditions under which the marijuana is
stored, tracked, or administered.
``(ii) If an applicant amends or supplements the research
protocol or initiates research on a new research protocol
under clause (i), the applicant shall, in order to renew the
registration under this paragraph, provide notice to the
Attorney General of the amended or supplemented research
protocol or any new research protocol in the applicant's
renewal materials.
``(iii)(I) If an applicant amends or supplements a research
protocol and the amendment or supplement involves a change to
the type of marijuana, the source of the marijuana, or
conditions under which the marijuana is stored, tracked, or
administered, the applicant shall provide notice to the
Attorney General not later than 30 days before proceeding on
such amended or supplemental research or new research
protocol, as the case may be.
``(II) If the Attorney General does not object during the
30-day period following a notification under subclause (I),
the applicant may proceed with the amended or supplemental
research or new research protocol.
``(iv) The Attorney General may object to an amended or
supplemental protocol or a new research protocol under clause
(i) or (iii) only if additional security measures are needed
to safeguard against diversion or abuse.
``(G) If marijuana is listed on a schedule other than
schedule I, the provisions of paragraphs (1), (2), and (4)
that apply to research with a controlled substance in the
applicable schedule shall apply to research with marijuana or
that compound, as applicable, in lieu of the provisions of
subparagraphs (A) through (F) of this paragraph.
``(H) Nothing in this paragraph shall be construed as
limiting the authority of the Secretary under section 505(i)
of the Federal Food, Drug, and Cosmetic Act or over
requirements related to research protocols, including changes
in--
``(i) the method of administration of marijuana;
``(ii) the dosing of marijuana; and
``(iii) the number of individuals or patients involved in
research.''.

SEC. 3. MANUFACTURE AND DISTRIBUTION OF MARIJUANA FOR USE IN
LEGITIMATE RESEARCH.

Section 303 of the Controlled Substances Act (21 U.S.C.
823), as amended by section 2, is further amended by adding
at the end the following:
``(l) Registration of Persons to Manufacture and Distribute
Marijuana for Use in Legitimate Research.--
``(1) Registration of manufacturers.--
``(A) In general.--Beginning not later than the day that is
1 year after the date of enactment of the Medical Marijuana
Research Act, the Attorney General, pursuant to subsection
(f)(3) and subject to subparagraph (B) of this paragraph,
shall register an applicant to manufacture marijuana
(including any derivative, extract, preparation, and compound
thereof) that is intended for--
``(i) the ultimate and exclusive use by qualified marijuana
researchers for research pursuant to subsection (f)(3); or
``(ii) subsequent downstream manufacture by a duly
registered manufacturer for the ultimate and exclusive use by
qualified marijuana researchers for research pursuant to
subsection (f)(3).
``(B) Public interest.--The Attorney General shall register
an applicant under subparagraph (A) unless the Attorney
General determines that the issuance of such registration is
inconsistent with the public interest. In determining the
public interest, the Attorney General shall take into
consideration--
``(i) maintenance of effective controls against diversion
of marijuana and any controlled substance compounded
therefrom into other than legitimate medical, scientific, or
research channels;
``(ii) compliance with applicable State and local laws
relating to controlled substance misuse and diversion;
``(iii) prior conviction record of the applicant under
Federal or State laws relating to the manufacture,
distribution, or dispensing of such substances; and
``(iv) such other conduct which may threaten the public
health and safety.
``(2) Registration of distributors.--
``(A) In general.--Beginning not later than the day that is
1 year after the date of enactment of the Medical Marijuana
Research Act, the Attorney General shall register an
applicant to distribute marijuana (including any derivative,
extract, preparation, and compound thereof) that is intended
for the ultimate and exclusive use by qualified marijuana
researchers for research pursuant to subsection (f)(3) or
intended for subsequent downstream manufacture by a duly
registered manufacturer for use by qualified marijuana
researchers for research pursuant to such subsection, unless
the Attorney General determines that the issuance of such
registration is inconsistent with the public interest.
``(B) Public interest.--In determining the public interest
under subparagraph (A), the Attorney General shall take into
consideration--
``(i) the factors specified in clauses (i), (ii), (iii),
and (iv) of paragraph (1)(B); and
``(ii) past experience in the distribution of controlled
substances, and the existence of effective controls against
diversion.
``(3) No limit on number of manufacturers and
distributors.--Notwithstanding any other provision of law,
the Attorney General shall not impose or implement any limit
on the number of persons eligible to be registered to
manufacture or distribute marijuana pursuant to paragraph (1)
or (2).
``(4) Requirement to verify use for legitimate research.--
As a condition of registration under this section to
manufacture or distribute marijuana, the Attorney General
shall require the registrant--
``(A) to require any person to whom the marijuana will be
supplied to submit documentation demonstrating that the
marijuana (including any derivative, extract, preparation,
and compound thereof) will be ultimately used exclusively by
qualified marijuana researchers for research pursuant to
subsection (f)(3) or for subsequent downstream manufacture by
a duly registered manufacturer for use by qualified marijuana
researchers for research pursuant to such subsection;
``(B) in the case of distribution, to complete, with
respect to that distribution, the appropriate order form in
accordance with section 308 and to upload such forms to the
system used by the Drug Enforcement Administration for such
distribution;
``(C) to include in the labeling of any marijuana so
manufactured or distributed--
``(i) the following statement: `This material is for
biomedical and scientific research purposes only.'; and
``(ii) the name of the requestor of the marijuana;
``(D) to limit the transfer and sale of any marijuana under
this subsection--
``(i) to researchers who are registered under this Act to
conduct research with marijuana or to manufacturers duly
registered under this subsection; 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 or for the purposes of further manufacturing of
marijuana; and
``(E) to transfer or sell any marijuana manufactured under
this subsection only with prior, written consent for the
transfer or sale by the Attorney General.
``(5) Timing.--Not later than 60 days after receipt of a
request for registration under this subsection to manufacture
or distribute marijuana, the Attorney General shall--
``(A) grant or deny the request; and
``(B) in the case of a denial, provide a written
explanation of the basis for the denial.
``(6) Deemed approval.--If the Attorney General fails to
grant or deny a request for registration under this
subsection to manufacture or distribute marijuana within the
60-day period referred to in paragraph (5), such request is
deemed approved.''.

SEC. 4. TERMINATION OF INTERDISCIPLINARY REVIEW PROCESS FOR
NON-NIH-FUNDED QUALIFIED MARIJUANA 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) create an additional review of scientific protocols
that is only conducted for research on marijuana other than
the review of research protocols performed at the request of
a qualified marijuana researcher conducting

[[Page H7078]]

nonhuman research that is not federally funded, in accordance
with section 303(f)(3)(A) of the Controlled Substances Act,
as added by section 2 of this Act.

SEC. 5. CONSIDERATION OF RESULTS OF RESEARCH.

Immediately upon the approval by the Food and Drug
Administration of an application for a drug that contains
marijuana (as defined in section 102 of the Controlled
Substances Act (21 U.S.C. 802), as amended by section 8 of
this Act) under section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355), and (irrespective of whether
any such approval is granted) not later than the date that is
5 years after the date of enactment of this Act, the
Secretary of Health and Human Services shall--
(1) conduct a review of existing medical and other research
with respect to marijuana;
(2) submit a report to the Congress on the results of such
review; and
(3) include in such report whether, taking into
consideration the factors listed in section 201(c) of the
Controlled Substances Act (21 U.S.C. 811(c)), as well as any
potential for medical benefits, any gaps in research, and any
impacts of Federal restrictions and policy on research,
marijuana should be transferred to a schedule other than
schedule I (if marijuana has not been so transferred
already).

SEC. 6. PRODUCTION QUOTAS FOR MARIJUANA GROWN FOR LEGITIMATE,
SCIENTIFIC RESEARCH.

Section 306 of the Controlled Substances Act (21 U.S.C.
826) is amended by adding at the end the following:
``(j) The Attorney General may only establish a quota for
production of marijuana that is manufactured and distributed
in accordance with the Medical Marijuana Research Act that
meets the changing medical, scientific, and industrial needs
for marijuana.''.

SEC. 7. ARTICLE 28 OF THE SINGLE CONVENTION ON NARCOTIC
DRUGS.

Article 28 of the Single Convention on Narcotic Drugs shall
not be construed to prohibit, or impose additional
restrictions upon, research involving marijuana, or the
manufacture, distribution, or dispensing of marijuana, that
is conducted in accordance with the Controlled Substances Act
(21 U.S.C. 801 et seq.), this Act, and the amendments made by
this Act.

SEC. 8. DEFINITIONS.

(a) Qualified Marijuana Researcher.--In this Act, the term
``qualified marijuana researcher'' has the meaning given the
term in section 303(f)(3) of the Controlled Substances Act,
as added by section 2(d) of this Act.
(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. 9. 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.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New
Jersey (Mr. Pallone) and the gentleman from Oregon (Mr. Walden) 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. 3797.
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 today in support of H.R. 3797, the Medical
Marijuana Research Act. In recent years, including in this most recent
election cycle, many States have taken action to allow cannabis use.
While States are moving ahead with this action, there is a significant
need for more research about the use of cannabis products in these
States and the safety of products on the shelves.
According to the National Conference of State Legislators, 36 States,
as well as Puerto Rico, Guam, the U.S. Virgin Islands, and the District
of Columbia have approved medical cannabis programs, while 15 States,
the District of Columbia, Guam, and the Northern Mariana Islands have
approved adult-use cannabis. This is a major shift in cannabis policy,
and the United States is not the only one making these changes.
Just last week, in a vote by the United Nations Commission on
Narcotic Drugs, the body acknowledged the medicinal and therapeutic
potential of cannabis and removed it from the most restrictive
classification category. While still voicing a need for control, the
United States voted in favor of this move, stating that the legitimate
medical use of cannabis has been established through scientific
research.
Unfortunately, American researchers seeking to study the products
widely available and used by consumers in these States and territories
face restrictions and numerous hurdles created by U.S. Federal policy.
It is time we break through this catch-22. This bipartisan bill begins
to address this issue by reducing barriers to cannabis research.
In January, the Committee on Energy and Commerce heard from Federal
officials about the difficulty researchers face when it comes to
conducting research with cannabis. As an example, for years, there has
been only one source of marijuana made available by the University of
Mississippi that can be used in the U.S. for research purposes. Another
difficulty is that the current Federal registration requirements can be
time-consuming and add unique and additional responsibilities than what
is required for other types of medical research.
The Council on Governmental Relations, an association of research
universities and other entities, says that this more cumbersome process
often requires 6 to 12 months to complete.
In testimony before our committee on this bill, Dr. Nora Volkow, who
is the director of the National Institute on Drug Abuse, underscored
this point. She testified that barriers in the current process
``present challenges to advancing cannabis research.'' As a result, she
said, we have a gap in our understanding of cannabis products on
health.
Mr. Speaker, now this bill, H.R. 3797, addresses some of these
barriers by streamlining the registration process for those who want to
advance cannabis research. The bill does this while still maintaining
appropriate oversight from both the Department of Health and Human
Services and the Drug Enforcement Administration.
This bill also requires HHS and DEA to act within specified time
periods to ensure timely registration for researchers, and it
encourages additional manufacturers and distributors to supply cannabis
for purposes of research. This will diversify the range of products and
make it easier for legitimate researchers to obtain products that
better reflect the changing cannabis landscape.
Mr. Speaker, finally, the bill would also promote research on
cannabis products available through State-authorized programs. This
additional research is critical if we are to better understand the
benefits and risks of cannabis products available in State markets
today and most frequently used by consumers.
Mr. Speaker, I thank the lead sponsors of this bipartisan
legislation, Representatives Blumenauer, Harris, Lofgren, Griffith,
Bishop, and Dingell, and their staffs, for their tireless work. I also
thank the committee staff for their hard work, as well as the staff for
both HHS and DEA for their technical assistance.
Mr. Speaker, again, I urge my colleagues to support this bill. I hope
the Senate will act on it swiftly, and I reserve the balance of my
time.
House of Representatives,

Committee on the Judiciary,

[[Page H7079]]

Please place this letter into the Congressional Record
during consideration of the measure on the House floor. Thank
you for the cooperative spirit in which you have worked
regarding this matter and others between our committees.
Sincerely,
Jerrold Nadler,
Chairman.
____

House of Representatives,

Committee on the Judiciary,

Washington, DC, December 7, 2020.
Hon. Frank Pallone, Jr.,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Chairman Pallone: This is to advise you that the
Committee on the Judiciary has now had an opportunity to
review the provisions in H.R. 3797, the ``Medical Marijuana
Research Act of 2019,'' that fall within our Rule X
jurisdiction. I appreciate your consulting with us on those
provisions. The Judiciary Committee has no objection to your
including them in the bill for consideration on the House
floor, and to expedite that consideration is willing to forgo
action on H.R. 3797, with the understanding that we do not
thereby waive any future jurisdictional claim over those
provisions or their subject matters.
In the event a House-Senate conference on this or similar
legislation is convened, the Judiciary Committee reserves the
right to request an appropriate number of conferees to
address any concerns with these or similar provisions that
may arise in conference.
Please place this letter into the Congressional Record
during consideration of the measure on the House floor. Thank
you for the cooperative spirit in which you have worked
regarding this matter and others between our committees.
Sincerely,
Jerrold Nadler,
Chairman.
Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today to express my support of H.R. 3797, the
Medical Marijuana Research Act introduced by my colleague and friend
from Oregon, Representative Blumenauer, my friend from Maryland,
Representative Andy Harris, among others.
I am sort of surprised we aren't taking this up at 4:20 in the
afternoon rather than 2:10, but we will let history deal with that.
Mr. Speaker, Federally sanctioned research on marijuana is incredibly
challenging. It is a schedule I controlled substance under the
Controlled Substances Act, meaning that researchers seeking to
investigate a drug have to work with the Department of Health and Human
Services and the Drug Enforcement Administration to meet certain
Federal requirements in order to conduct that research.
In addition, international obligations outlined in the United Nations
drug control treaties impose requirements that impact the supply of
research-grade cannabis. Currently, those conducting federally-
sanctioned research can only study marijuana that is sourced through
the National Institute on Drug Abuse's single DEA licensee: the
University of Mississippi.
Unfortunately, that marijuana is chemically distinct from what is
commercially available from State-legal dispensaries, such as in my
home State of Oregon.
What does that mean?
Well, it means that we have little to no data on the actual health
impacts of products in States that have legalized cannabis for medical
or recreational use.
States that have pursued marijuana legalization have largely done so
in an information vacuum, with less understanding of 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. We don't even know at what point it
is unsafe for marijuana users to drive. The THC levels that States have
set for driving legal limits or for purposes of food consumption are
simply arbitrary.
Mr. Speaker, in Oregon, for example, cookies infused with THC are
limited to 5 milligrams of THC per serving, or 50 milligrams per
package. Now, you go across the Columbia River to the great State of
Washington, and their limit is 10 milligrams or 100 milligrams. So
there is little to no scientific evidence to support either of these
levels. We simply don't know.
Mr. Speaker, here is what we do know: There have been increases in
cannabis-related poison control center calls, emergency room visits,
and impaired driving incidents. Nationwide exposure in youth is
increasing, with record numbers of 8th through 12th graders regularly
vaping marijuana products.
So we need research that reflects the reality of what is on the
market. Products containing CBD derived from the hemp plant have become
commonplace across the country in pharmacies and health food stores,
and even in fast food chains since hemp was removed from the CSA in the
2018 farm bill.
Now, these products often contain claims that they can effectively
treat everything from depression and inflammation to cancer or
Alzheimer's. However, none of these claims have been evaluated or
approved by the FDA, meaning patients may be relying on the
unsubstantiated claims of CBD products and foregoing other proven
medical treatments.
Mr. Speaker, like cannabis, while there is potential for CBD to
provide patient benefits, the research and science lag far behind the
market and the agencies are simply struggling to catch up. Last week,
the majority forced this Chamber to vote on the MORE Act, which
completely removed marijuana from the list of scheduled substances
under the Controlled Substances Act--among many other things in that
bill--and they didn't have the data to justify this policy decision.
Not only was this legislation incredibly premature, it could also
potentially put the U.S. in violation of international treaty
obligations. Any discussion of de-scheduling must be preceded by a
fuller understanding of the potential risks associated with cannabis
use, which we currently do not have. And the current research
restrictions on fully studying cannabis have effectively created a
catch-22 in the rescheduling debate.
So evaluations by the FDA and the National Academies have both
concluded that the lack of research is a significant factor in denying
previous administrative rescheduling petitions. More research, better
data, remain the critical first steps to any future policy discussions.
Making it easier to research cannabis is common ground that I think we
can all agree upon and pursue together.
Mr. Speaker, I thank my colleagues, and especially Representatives
Harris and Blumenauer, for working tirelessly to bring us this
bipartisan, commonsense legislation. This bill will help improve the
marijuana research landscape and give consumers the information they
need.
Mr. Speaker, I urge a ``yes'' vote on this measure, and I reserve the
balance of my time.
Mr. PALLONE. Mr. Speaker, I want to thank the gentleman from Oregon.
He has really been out front in educating me, in particular, and so
many of us, on the cannabis issue. I think without him, we would not
see many States like my own leaning towards legalization.
Mr. Speaker, I yield 3 minutes to the gentleman from Oregon (Mr.
Blumenauer), the prime sponsor of the bill.

{time} 1415

Mr. BLUMENAUER. Mr. Speaker, I appreciate the gentleman's kind
comments and cooperation. Working with the ranking member, working with
Dr. Harris, we made real progress here.
Mr. Speaker, the cannabis laws in this country are broken, especially
those that deal with research. It is illegal everywhere in America to
drive under the influence of alcohol, cannabis, or any other substance.
But we do not have a good test for impairment because we can't study
it. Now, Dr. Harris and I don't necessarily agree on the efficacy of
cannabis, but we agree that this is insane and that we need to change
it.
At a time when there are 4 million registered medical cannabis
patients, and many more who self-medicate, when there are 91 percent of
Americans supporting medical cannabis, it is time to change the system.
Our bill will do precisely that. We have a broad coalition of Members
and organizations who support the bill, including those who do have
concerns about cannabis.
Specifically, the bill will tackle two main issues: research
licensing and manufacturing. For manufacturers, it requires the DEA to
license outside of the NIDA monopoly so we can study the products
Americans are using. For researchers, it shortens the timelines,
reduces unnecessary security measures, and streamlines approval.

[[Page H7080]]

This bill will not only reduce barriers to medical research but all
cannabis research. It is a narrow bill that fixes one of many broken
cannabis laws.
I want to hasten to add that this in no way negates the need to move
forward with other areas of legislation, like we did with the MORE Act.
But this is sort of a foundational question. No matter where you are,
there is no reason the Federal Government should impede this critical
research.
One of the most moving moments I have had in the last 2 years working
on this issue was in the backyard of a constituent in southeast
Portland who brought together a half dozen families with children with
extreme seizure disorder. The only thing that stopped those babies from
being tortured was medical cannabis. They had to research it
themselves. They had to formulate it themselves.
At Oregon Health and Science University, they told me: This works. We
know it works. We could go to the street corner and buy something, but
we legally can't do it.
Listening to those heartbreaking stories of the families, of what
they had to do--they crossed their fingers. It sort of worked for them.
But no family should have to do that.
We ought to get the Federal obstacles out of the way of simple,
commonsense research. It will make a difference for families across the
country. We need to move forward, so there is no unnecessary dispute
about cannabis, and get the job done.

Support the Medical Marijuana Research Act

Dear Colleague: We write to encourage you to cosponsor our
bill, the Medical Marijuana Research Act (H.R. 3797).
Regardless of your stance on marijuana, we can all agree that
there should not be onerous federal barriers to conduct
research and access objective evidence as to the medicinal
properties of marijuana.
Although more than two-thirds of Americans are living in
states with legal marijuana programs, current federal law
greatly limits researchers' ability to research this drug.
This includes the overly burdensome registration process,
redundant protocol reviews, lack of adequate research
material and unnecessarily onerous security requirements. In
fact, a 2017 National Academies of Sciences, Engineering, and
Medicine report found that ``research on the health effects
of cannabis and cannabinoids has been limited in the United
States, leaving patients, health care professionals, and
policy makers without the evidence they need to make sound
decisions regarding the use of cannabis and cannabinoids.
This lack of evidence-based information on the health effects
of cannabis and cannabinoids poses a public health risk.'' We
could not agree more.
The Medical Marijuana Research Act will reduce many of the
barriers to conducting legitimate medical marijuana research.
First, the bill streamlines the burdensome and often
duplicative licensure process for researchers seeking to
conduct marijuana research, while still maintaining all
necessary safeguards against misuse and abuse. Second, it
addresses the woefully inadequate, both in quantity and
quality, supply of medical-grade marijuana available for use
in such research. Finally, it requires, within five years of
enactment, a report by the secretary of the U.S. Department
of Health and Human Services on the status and results of the
then-available body of research on marijuana.
Irrespective of where one falls on the ideological spectrum
with respect to further legalization, we can all agree that
the American people deserve to know what's going on with
marijuana. The United States leads the world in biomedical
research. It is therefore unconscionable that the federal
government stands as the chief impediment to legitimate
medical research that will ensure American physicians,
patients, purchasers, and constituents have access to the
information they need to make an informed decision about
marijuana.
Sincerely,
Earl Blumenauer,
Member of Congress.
Andy Harris, M.D.,
Member of Congress.
Mr. WALDEN. Mr. Speaker, I yield 3 minutes to the gentleman from
Maryland (Mr. Harris), who has been a real leader on this and so many
other healthcare-related issues.
Mr. HARRIS. Mr. Speaker, I thank you for your concern about addiction
and all the problems. This is an ancillary problem that deals with
that. I thank you for your concern about that.
I thank the chairman of the committee and the ranking member. This
has been years in the making. I thank them for bringing this across the
finish line.
I thank my cosponsor from across the aisle. The gentleman from Oregon
is absolutely right. He and I will disagree, probably the most two
people can disagree, about recreational marijuana. We agree 100 percent
that we need to do this research and that we need this bill.
Now, because of the discussion about COVID and the vaccines and
therapeutics for that, Americans realize how medical research has to be
done and how important it is to be done. They expect purity, safety,
and efficacy for anything that has a claim of a medical product.
Now, unfortunately, because of the public policy we have had in place
with marijuana and its scheduling, this simply couldn't be done. The
unfortunate consequence is that legislatures in general across the
States, and, unfortunately, this legislature last week, took a ready-
fire-aim approach: Let's go ahead and legalize it, even for
recreational use, without a medical basis.
But I am only going to talk about medical marijuana. We need good
studies. Understandably, because of current scheduling, we can't do it.
I get it. I did research, as a physician, on drugs. You can't do it
under the current scheduling, but we need to do the research.
As the chairman pointed out, Dr. Volkow, who has appeared before our
committee many times, has said that the claims of medical usefulness
are simply greatly exaggerated because we don't have the science. Many
claims are made; very few are proven.
We don't tolerate that for other medications. We certainly don't
tolerate it for COVID vaccines and therapeutics. We shouldn't tolerate
it for medical marijuana. This research just simply hasn't been done,
for a variety of reasons, most of which get cured by this bill.
Now, could medical marijuana be useful for PTSD for my fellow
veterans? Absolutely. It might be useful. We have no idea.
What we have done is, instead, the public press has said it is useful
for PTSD. That is not the way we treat medicine in this country. We
actually do the research. Our veterans deserve for us to do this
research.
It couldn't be done, because of the scheduling, because of the
rules--the rules, by the way, that Congress made. This is on us. We
shouldn't have taken so long to get to this point.
Could it be useful for non-neurogenic chronic pain? Yes, it might be,
but I don't know. The last thing we should do to our chronic pain
patients, as you know, Mr. Speaker, because of the problems with
treating chronic pain, is make false promises to them about something.
If this works for it, oh, my gosh, that is great. We have a potential
solution for part of our addiction problem. If it doesn't work, those
people deserve to know.
The SPEAKER pro tempore (Mr. Trone). The time of the gentleman has
expired.
Mr. WALDEN. Mr. Speaker, I yield an additional 1 minute to the
gentleman from Maryland (Mr. Harris).
Mr. HARRIS. Mr. Speaker, is it useful for that group? Is CBD useful
for that group of pediatric patients with seizures? Yes, it sure is. Is
it useful for people with glaucoma? Yes, it sure is. Is it useful for
spasticity with multiple sclerosis? Yes, it sure is.
But there are 40 or 50 other claims that we don't know about. We
deserve to know about it. Those claims are simply not founded on
science.
Look, let's do the science. Let's see what medical marijuana is
useful for. As a physician, anything it is useful for, I want to
provide for patients. Let's do the science. Let's pass H.R. 3797.
Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentlewoman from
Michigan (Mrs. Dingell), one of our colleagues on the committee.
Mrs. DINGELL. Mr. Speaker, I rise in strong support of the Medical
Marijuana Research Act, which would streamline outdated bureaucratic
barriers and Federal roadblocks preventing legitimate medical research
into the impacts of medical marijuana.
I, too, like my colleague, thank you for your leadership. I have a
healthy fear of drugs, having lost a sister to a drug overdose, but
there is just too much information we do not have.
We have seen dramatic changes in the legal status of marijuana at the
State level. Almost 1 year ago to the day, sales of recreational
marijuana began in my home State of Michigan.

[[Page H7081]]

Following multiple successful State ballot initiatives last month,
medical marijuana is now legal in 36 States. However, the Federal
framework for conducting marijuana research is decades old and has not
kept pace with these changes.
Currently, as has been said by my other colleagues, scientists in the
United States looking to conduct research on marijuana must contend
with a heavy-handed, duplicative registration and licensure process
that doesn't work. They are limited to using marijuana grown at a
single location overseen by the National Institute on Drug Abuse at the
University of Mississippi.
Collectively, this regulatory red tape greatly limits our
understanding of the health impacts of marijuana and prevents qualified
researchers from engaging in further study.
We are driving cars that NHTSA can't do the research they need to do
about people driving while smoking. We should know that.
The Medical Marijuana Research Act will streamline this cumbersome
process by preventing bureaucratic roadblocks on marijuana research
registration applications. It will also direct the FDA to issue
guidelines on the production of marijuana and ensure that adequate
amounts are available for research.

The legislation also mandates a comprehensive review of the available
body of research on marijuana by the Secretary of Health and Human
Services 5 years after enactment.
I thank my colleagues--Congresspersons Blumenauer, Griffith, Lofgren,
Harris, and Rob Bishop--for all of their work on this. This does
matter. We need answers. And I thank my chairman, who has been great
about this.
I refuse to accept the fact that our Ranking Member Walden is
leaving. He is a dear friend, and he has made so much of a difference.
He has had very thoughtful input on this, as he does on everything.
Mr. Speaker, it is high time we modernize our Nation's Federal
regulations to facilitate legitimate medical research into the impacts
of marijuana, and I urge my colleagues to support this legislation.
Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume.
I thank the gentlewoman from Michigan for her kind comments and her
leadership on this legislation.
Mr. Speaker, can I inquire how much time is remaining?
The SPEAKER pro tempore. The gentleman from Oregon has 11\1/2\
minutes remaining.
Mr. WALDEN. Mr. Speaker, I yield such time as he may consume to the
gentleman from Virginia (Mr. Griffith), an extraordinary leader on the
Energy and Commerce Committee, a gentleman I refer to as our counsel on
the committee. He is an extraordinary lawyer and incredible public
policy initiator.
Mr. GRIFFITH. Mr. Speaker, I appreciate that this bill has made it to
this level.
You know, Congress doesn't always work well, but sometimes it does.
Andy Harris and I were back here, about where he is sitting right now,
having a discussion one day, because a lot of times, things get solved
or issues come to a head because we are trying to solve problems for
the American people.
I believe that there are many uses for medicinal marijuana. I don't
support recreational use, but I support medicinal use. Andy thinks that
it goes way too far, as you heard him just say.
But the bottom line is, as we were discussing it, neither one of us
could cite scientific research to support our positions. So, we agreed
at that point that we would work together on our side of the aisle. And
obviously, the gentleman from Oregon has been leading on this for many,
many years, and he was going to lead on the other side. We agreed we
would try to find language that worked.
We have tried some backdoor routes to get it through some Energy and
Commerce bills before, schedule 1R to do research. But this is
extremely important. And you are either for medicinal marijuana or
against medicinal marijuana, but you can't make an argument either way
without the proper research.
This fine piece of legislation that was hammered out over a couple of
years, maybe as many as 5 years, is a good piece of legislation, and it
deserves the unanimous support of this United States House. I recommend
it to each and every one of you.
That being said, I would like to take another minute to speak about
my relationship with my Ranking Member Walden, who is leaving us. It is
with regret on my part that he is leaving. He has a life to lead, and
that is what people sometimes forget about Members of Congress.
There is life after Congress, and he is going to do some interesting
things. I am anxious to learn what they are. He says he is anxious to
learn what they are, too.
But he has so much talent. He has led our committee and then our side
of the aisle on the committee so well, and has allowed those of us who
are a little different sometimes to have some interesting ideas, to
have those ideas bubble up, to take some interesting votes sometimes in
committee, to allow Members down dais to have significant input. I am
greatly appreciative of that.
I am also appreciative of his friendship and loyalty. I remember when
we discovered that his longtime friend Ray Baum had a fatal disease,
how he stuck with him, how Ray kept coming to work and was doing things
all the way through, and then how he passed an important piece of
legislation which commemorated all of Ray Baum's work.
The bill has Ray Baum's name on it, as it should, but it was a
tribute from his friend, and I respect that type of friendship. I
appreciate it very much.
I will always hold you in high regard. If I can do anything to be of
assistance in the future, I will gladly do so.
Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I want to thank my friend and colleague from Virginia
for not only his very kind comments but also his incredible work ethic.
I will tell one quick story about Morgan Griffith. I had a little
bill, a suspension bill, that Mr. Blumenauer and I had to do a land
exchange up on Mount Hood. It flew through here one night, first night
of votes, and got two dissenting votes. One of them I understood, but
his dissenting vote I didn't understand.
I went up to him, and I said: I am going to win this. There are only
two noes. But why did you vote no?
He said: Well, I read the bill, and it referenced this memorandum of
understanding between the Forest Service and Mount Hood Meadows about
this land exchange. I tried to get a copy of that MOU, and I couldn't
get it before I voted on the bill, so I voted no.

{time} 1430

Well, the bill didn't get through that Congress. It got through the
House, but not, of course, the other body.
So the next Congress, we did it again, and I made sure that Mr.
Griffith had that memorandum of understanding related to this little
land transfer bill in an area that Mr. Blumenauer and I share, and he
voted with us on that measure.
I thought: He is a pretty darn good, thorough legislator if he is
reading every suspension bill and every land transfer bill and diving
into the weeds. Americans need to know what a great man he is.
Mr. Speaker, I yield such time as he may consume to the gentleman
from Georgia (Mr. Carter).
Mr. CARTER of Georgia. Mr. Speaker, I rise in support of the Medical
Marijuana Research Act.
Cannabis has been known by humans for thousands of years, yet we
still don't truly know if the plant is medically beneficial. Some
preliminary findings have given cause to believe that there may be some
medicinal benefits. In fact, the FDA has authorized use of medical-
grade CBD products for rare forms of epilepsy, but large-scale research
has not occurred.
Despite this, more than half of the States have legalized cannabis
for medical purposes. Even Georgia, my home State, has acted to expand
cannabis laws.
As the legal status of cannabis evolves, we must prioritize making
the plant available for medicinal research.
In 2017, the National Academy of Medicine found that there are
several challenges and barriers in conducting cannabis and cannabinoid
research, including the classification of cannabis

[[Page H7082]]

as a schedule I substance and the difficulty for researchers to gain
access to the quality and quantity of product necessary for research.
I do not believe that the Federal Government should be standing in
the way of medical research for cannabis products. Cannabis could be a
lifesaving product. It may also not be, but we owe it to the patients
to do the due diligence, research, and testing so that they may make
the best medical decisions for themselves.
While we may all have differing opinions on the decriminalization of
recreational marijuana--and my stance on that is well-known and well-
documented that I am adamantly opposed to the recreational use of
marijuana--I think we can all agree that we should facilitate better
research on the plant's medicinal benefits.
Mr. Speaker, I am glad to see this legislation come to the floor for
a vote. I thank my colleague, Mr. Blumenauer, for working on this
legislation with me. I urge passage of this legislation.
Mr. Speaker, before I leave, I want to pay homage, if you will, to
Mr. Walden, who will be leaving us, you have heard other speakers
indicate before.
I came on this committee 4 years ago. Being the only pharmacist in
Congress, I wanted to be on the Health Subcommittee, and I wanted to
work in that arena. That is where Energy and Commerce was.
I will have to be quite honest with you. I really didn't understand
just what a great committee--the best committee in Congress--Energy and
Commerce is, and I truly believe that. I understand that now.
But I want to thank Greg Walden, because when I came in 4 years
ago, he was the chairman of this committee, and he was very encouraging
to me. In fact, he was my mentor on this committee. He led me and gave
me opportunities, and I appreciate that very, very much.
His diversity, his intelligence, his fairness has been outstanding.
His leadership has been outstanding, and it is only surpassed by his
impeccable character.
Mr. Speaker, as he leaves, I want him to know how much I personally
am appreciative of all of his help and all of his leadership.
Our committee, our Congress, our country is better off because of
your work. Thank you and Godspeed.
Mr. WALDEN. Mr. Speaker, I want to thank my dear friend and colleague
from Georgia (Mr. Carter) for his leadership on so many issues before
the committee and for his very kind and generous words. I will miss
serving with Mr. Carter. He has been a terrific member of the
committee, and he, too, will have a great future ahead.
Mr. Speaker, our next Member, I should call him the deputy mayor of
Washington, D.C., because that is kind of what you are when you are the
ranking member of the House Administration Committee. He has been a
passionate advocate on the next bill, but because of a meeting he has
coming up, I am going to yield to him now, so he can make that
scheduled appointment, to talk about this bill and the next bill.
Mr. Speaker, I yield such time as he may consume to the gentleman
from Illinois (Mr. Rodney Davis).
Mr. RODNEY DAVIS of Illinois. Mr. Speaker, I do support the bill that
we are talking about. I have been a longtime supporter of medical
marijuana use, and I certainly believe that the bipartisan legislation
that is being put forward today is a great idea.
But it is also great to follow my favorite legalized drug dealer here
at the dais, Buddy Carter, the only pharmacist in Congress. This is a
guy who says a lot of things about Greg Walden. All of them are true,
but I am going to get to that in a bit.
Mr. Speaker, I am here to thank my good friend, Donald Payne, Jr.,
for allowing me to cosponsor a bill that is very personal to me, and
that is the Removing Barriers to Colorectal Cancer Screening Act of
2020.
As some of you may know, my wife was diagnosed with early-onset
colorectal cancer in 1999. She was 26 years old, and she is a 21-year
cancer survivor today. It is a genetic form of cancer, Lynch syndrome,
that I hope and pray that families like mine and many others don't have
to continue to fight.
But it is imperative that we catch cancer in its early stages, and I
can speak from experience, with my wife constantly being misdiagnosed
just a few short years ago, and that is exactly what this legislation
does for our Medicare population.
Put simply, this legislation ensures that, if a Medicare beneficiary
receives a colonoscopy, which is covered by Medicare, he or she won't
be billed for any subsequent tests on polyps that may be discovered
during the screening.

The current policy of providing colonoscopies at no cost to
beneficiaries but then billing them for potential findings, that
greatly disincentivizes vulnerable individuals from actually seeking
the screening process, which could lead to worse cancer and possibly
death.
This is a commonsense fix that will save lives. I am proud to colead
it, again, with my good friend, Mr. Payne. This is bipartisan.
But before I close, I want to take a moment to thank the countless
advocates who have visited my office to fight for increased screening,
including those with Fight Colorectal Cancer and the American Cancer
Society. Today's vote stands as a testament to their advocacy and hard
work.
Mr. Speaker, I want to thank, again, Chairman Pallone and Ranking
Member Walden and everyone on the Energy and Commerce Committee and the
Ways and Means Committee for working with us to move this legislation
forward.
Mr. Speaker, I urge my colleagues to vote ``yes.''
Mr. Speaker, now I do want to take some time--it is actually ironic
to watch all of the well wishes to Greg Walden.
After first meeting him on an airplane that happened to land at the
wrong airport, I didn't have a lot of high hopes for you, Mr. Ranking
Member. I mean, who lands at the wrong airport, except an airplane that
Greg Walden is on?
Unlike a lot of folks that are here touting what you have done, I
say: Good riddance. It is about time.
In all seriousness, my friend, this place is going to miss you. This
place is going to miss your humor. This place is going to miss your
leadership and your tenacity. I can't tell you how proud I am to not
just call you my colleague, but my friend.
Thank you for everything you have done for me and what you have done
for this great institution. It is a better place because you served
here, and it will not be as good a place without you here.
Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I want to thank my friend from Illinois for his generous
comments and his great leadership, and I wish him well in the future.
Mr. Speaker, I urge passage of the underlying bill, and I yield back
the balance of my time.
Mr. PALLONE. Mr. Speaker, I ask for support to pass this legislation,
and I yield back the balance of my time.
Ms. ESHOO. Mr. Speaker, I rise in support of H.R. 3797, the Medical
Marijuana Research Act. I advanced 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, 44 million Americans reported using cannabis in the
past year. Thirty-three states now allow the medicinal use of cannabis
and 11 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.

[[Page H7083]]

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.
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. 3797, as amended.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill, as amended, was passed.
A motion to reconsider was laid on the table.

____________________