Medical Marijuana Research Act
Floor Speech
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Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass the bill (H.R. 5657) 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. 5657
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 (including any derivative, extract, preparation, and compound thereof) if, irrespective of whether the applicant is registered pursuant to paragraphs (1) and (2)--
``(i) the applicant meets the requirements for being registered under such paragraphs 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.
``(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 (including any derivative, extract, preparation, and compound thereof), 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) use by qualified marijuana researchers for research pursuant to subsection (f)(3); or
``(ii) subsequent downstream manufacture by a duly registered manufacturer for 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 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 used 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 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.
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Mr. PALLONE. 5657.
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Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume.
Madam Speaker, I rise in support of H.R. 5657, the Medical Marijuana Research Act.
Last week, Congress considered and passed the MORE Act, which effectively removes marijuana from the strictest category of regulation under the Controlled Substances Act. Today, medical marijuana is approved and regulated in 37 States, the District of Columbia, Guam, Puerto Rico, and the U.S. Virgin Islands. These actions highlight the need for increased research about safety and efficacy of the marijuana products being consumed by millions of Americans.
Unfortunately, comprehensive research on marijuana has been regulated in a restrictive, time-consuming way, and the current body of research is not representative of the products available to the average American adult consumer.
H.R. 5657 is a bipartisan bill that streamlines the registration process for scientists seeking to engage in cannabis research. It also maintains the appropriate oversight and control by the Department of Health and Human Services and the Drug Enforcement Administration.
The bill requires HHS and DEA to respond to registration applicants in a timely manner and expands the number of federally approved manufacturers and distributors that can supply marijuana products for research purposes.
The bill also creates a special process to allow State-authorized marijuana to be used for research purposes. This is an important step toward understanding the positive and negative health effects of the products being frequently consumed by people across our country.
The House passed this bill by a voice vote in the 116th Congress. The Senate also passed a similar measure last Congress and did so again by unanimous consent last month.
Madam Speaker, I want to thank Representatives Blumenauer, Harris, Holmes Norton, Dingell, Cohen, Griffith, Lee, and Case for their leadership on this issue. I look forward to working with them and our colleagues in the Senate to expand comprehensive cannabis research and protect the health of our constituents.
Madam Speaker, I urge my colleagues to support this bill, and I reserve the balance of my time.
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Mr. PALLONE. Madam Speaker, I yield such time as she may consume to the gentlewoman from Michigan (Mrs. Dingell), who is one of the sponsors of this legislation.
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Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume.
Let me agree with my Republican colleague that this is very important because there really hasn't been enough research done on marijuana and the impacts of it.
That is why this bill really needs to pass, and I urge my colleagues, on a bipartisan basis, to support it. I yield back the balance of my time.
Ms. JACKSON LEE. Madam Speaker, I rise in strong support of H.R. 5657, the Medical Marijuana Research Act.
The purpose of this bill is to amend the Controlled Substances Act to make marijuana accessible for use by qualified marijuana researchers for medical purposes, and for other purposes.
This bill establishes new, separate registration requirements to facilitate medical marijuana research.
It will remove the barriers on conducting cannabis research, by allowing scientists to access products from dispensaries that are legally authorized by state law.
Current barriers include the burdensome registration process, redundant protocol reviews, lack of adequate research material, and unnecessarily onerous security requirements.
The act will speed up the process for researchers to apply and get approved to study cannabis.
It will also set clear deadlines on federal agencies to act on their registration applications.
The bill also makes it easier for scientists to modify their research protocols without having to seek federal approval.
It would additionally require that the Drug Enforcement Administration (DEA) license more growers.
With this requirement there would be no limit on the number of additional entities that can be registered to cultivate marijuana for research purposes.
For half a century, researchers have only been able to study marijuana grown at the University of Mississippi, because it is the only federally approved facility.
These researchers have complained that it is difficult to obtain the medical marijuana at the facility, and when they do obtain it, it is low quality.
The medical marijuana that researchers at the University of Mississippi have access to is often compared to industrial hemp, a botanical class of Cannabis sativa that is grown specifically for industrial and medical use.
There are many differences between hemp and marijuana such as:
Hemp is specifically bred to produce plants because of its strong durable fibers, whereas marijuana is bred specifically for its resin properties, which is used for recreational purposes.
Hemp is bred to have less than .03 percent THC. THC is the mood- altering compound in marijuana. Regular marijuana has 1 percent to 30 percent of THC.
The hemp plant produces a high level of CBD oil and low levels of THC resin. Marijuana has a low level of CBD oil, and high levels of THC resin.
In humans, the CBD oil produced by the hemp plant works on the inflammatory systems of the brain which is why some patients say they get relief after using it. Marijuana works on the part of the brain that regulates mood and hunger.
The cannabis that government-authorized institutions typically access is more like hemp than marijuana, and marijuana is what consumers use in the real world.
These researchers need to have access to marijuana and not facility- grown hemp to further our education around the drug.
With this bill, the U.S. Department of Health and Human Services (HHS) and the U.S. attorney general would be required to create a process for marijuana manufacturers and distributors to supply researchers with cannabis from dispensaries.
This will allow researchers to be able to study the recreational marijuana that is being used and sold from state-legal businesses, instead of having to use only government grown cannabis.
Ninety-nine percent of Americans live in a state that has legalized some form of cannabis, yet the federal law is still hindering researchers' ability to study all the full range of health benefits.
Providing researchers with the actual marijuana that consumers are purchasing is the only way to provide the most efficient and relevant results.
We need to stop making researchers jump through regulatory hoops in their efforts to study the medical potential of the plant.
Expanding the marijuana studies will help ensure that Americans have adequate access to these potentially life changing medicines and treatments.
There are about 4 million registered cannabis patients in the United States, and likely millions more are self-medicating.
The United States leads the world in biomedical research yet research on cannabis, a drug that many of our citizens benefit from and are already using, lags far behind.
Limiting the resources for this research will leave patients, health care professionals, and policy makers without the evidence needed to make sound decisions about the use of marijuana.
I ask my colleagues to join me in voting for H.R. 5657 because providing the resources for this research could make the difference in millions of lives.
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