What This Bill Does
This bill increases the orphan drug tax credit (a discount on taxes for companies developing treatments for rare diseases) from 25 percent to 50 percent. It also directs the Centers for Disease Control and Prevention to study whether it can better track rare diseases across America.
Who It Affects
Companies that develop drugs for rare diseases will be directly affected by the tax credit increase. The Centers for Disease Control and Prevention will conduct the required study. Patients with rare diseases, disease experts, researchers and advocacy organizations may be consulted during the study.
Key Provisions
- Companies developing orphan drugs receive a tax credit increased from 25 percent to 50 percent for taxable years beginning after this law is enacted (Sec. 2)
- The Director of the Centers for Disease Control and Prevention must complete a study within one year after this law is enacted to evaluate whether infrastructure can be enhanced to better track rare disease information (Sec. 3(a))
- The CDC Director must consult with epidemiologists, disease researchers, patients, caregivers and other experts when conducting the study (Sec. 3(b))
- The CDC Director must submit a study report to Congress within three months after completing the study (Sec. 3(c))
What Changes
Companies claiming the orphan drug tax credit will receive double the tax benefit (50 percent instead of 25 percent) on qualifying drug development. The Centers for Disease Control and Prevention will conduct a new study on tracking rare diseases.
Important Definitions
"Rare diseases and conditions" means human diseases defined as rare under federal food and drug law, or diseases the CDC Director determines are rare and lack treatment options.
Effective Date
The tax credit increase applies to taxable years beginning after the date this Act is enacted. Not specified in bill text when that date will be.
I
118TH CONGRESS
1ST SESSION H. R. 1350
To amend the Internal Revenue Code of 1986 to restore the amount of
the orphan drug tax credit, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MARCH 3, 2023
Mr. GOTTHEIMER (for himself and Mr. BACON) introduced the following bill;
which was referred to the Committee on Ways and Means, and in addi-
tion to the Committee on Energy and Commerce, for a period to be sub-
sequently determined by the Speaker, in each case for consideration of
such provisions as fall within the jurisdiction of the committee concerned
A BILL
To amend the Internal Revenue Code of 1986 to restore
the amount of the orphan drug tax credit, and for other
purposes.
Be it enacted by the Senate and House of Representa-
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tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE.
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This Act may be cited as ‘‘Cameron’s Law’’.
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•HR 1350 IH
SEC. 2. RESTORATION OF AMOUNT OF ORPHAN DRUG TAX
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CREDIT.
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(a) IN GENERAL.—Section 45C(a) of the Internal
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Revenue Code of 1986 is amended by striking ‘‘25 per-
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cent’’ and inserting ‘‘50 percent’’.
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(b) EFFECTIVE DATE.—The amendment made by
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this section shall apply to taxable years beginning after
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the date of the enactment of this Act.
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SEC. 3. CDC FEASIBILITY STUDY ON SURVEILLANCE INFRA-
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STRUCTURE FOR RARE DISEASES AND CON-
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DITIONS.
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(a) STUDY.—Not later than 1 year after the date of
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enactment of this Act, the Director of the Centers for Dis-
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ease Control and Prevention (in this section referred to
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as the ‘‘Director’’) shall complete a study to evaluate the
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feasibility of enhancing and expanding the infrastructure
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to track the epidemiology of rare diseases and conditions,
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including with respect to the following:
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(1) Rates of mortality.
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(2) Potential for research and treatment.
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(3) Demographics.
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(4) Diagnosis and progression markers.
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(5) The history of the disease or condition.
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(6) Detection management.
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•HR 1350 IH
(b) CONSULTATION.—In conducting the study re-
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quired by subsection (a), the Director shall consult with
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relevant experts, including—
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(1) epidemiologists with experience in disease
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surveillance;
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(2) representatives of national voluntary health
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associations;
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(3) health information technology experts or
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other information management specialists;
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(4) clinicians with expertise in rare diseases or
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conditions;
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(5) research scientists with expertise in rare
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diseases or conditions, or experience conducting
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translational research or utilizing surveillance sys-
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tems for scientific research purposes; and
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(6) patients, and caregivers of patients, with
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rare diseases or conditions.
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(c) REPORT.—Not later than 3 months after com-
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pleting the study required by subsection (a), the Director
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shall submit a report to the Congress on the results of
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the study.
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(d) DEFINITION.—In this section, the terms ‘‘rare
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diseases and conditions’’ and ‘‘rare diseases or conditions’’
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refer to human diseases and conditions that are—
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•HR 1350 IH
(1) a rare disease or condition, as defined in
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section 526 of the Federal Food, Drug, and Cos-
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metic Act (21 U.S.C. 360bb); or
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(2) determined by the Director to be rare and
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lacking in treatment options, so as to warrant con-
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sideration in the study required by subsection (a).
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Æ
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