[House Report 113-565]
[From the U.S. Government Publishing Office]
113th Congress } { Rept. 113-565
2d Session } HOUSE OF REPRESENTATIVES { Part 2
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IMPROVING REGULATORY TRANSPARENCY
FOR NEW MEDICAL THERAPIES ACT
_______
September 19, 2014.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Goodlatte, from the Committee on the Judiciary, submitted the
following
R E P O R T
[To accompany H.R. 4299]
[Including cost estimate of the Congressional Budget Office]
The Committee on the Judiciary, to whom was referred the
bill (H.R. 4299) to amend the Controlled Substances Act with
respect to drug scheduling recommendations by the Secretary of
Health and Human Services, and with respect to registration of
manufacturers and distributors seeking to conduct clinical
testing, having considered the same, report favorably thereon
with an amendment and recommend that the bill as amended do
pass.
CONTENTS
Page
The Amendment.................................................... 1
Purpose and Summary.............................................. 2
Background and Need for the Legislation.......................... 2
Hearings......................................................... 3
Committee Consideration.......................................... 3
Committee Votes.................................................. 3
Committee Oversight Findings..................................... 3
New Budget Authority and Tax Expenditures........................ 4
Congressional Budget Office Cost Estimate........................ 4
Duplication of Federal Programs.................................. 5
Disclosure of Directed Rule Makings.............................. 5
Performance Goals and Objectives................................. 5
Advisory on Earmarks............................................. 5
Section-by-Section Analysis...................................... 5
Changes in Existing Law Made by the Bill, as Reported............ 6
The Amendment
The amendment is as follows:
Strike all that follows after the enacting clause, and insert
the following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Improving Regulatory Transparency for
New Medical Therapies Act''.
SEC. 2. SCHEDULING OF SUBSTANCES INCLUDED IN NEW FDA-APPROVED DRUGS.
Section 201(a) of the Controlled Substances Act (21 U.S.C. 811(a)) is
amended by adding at the end the following: ``Any such proceedings
initiated at the request of the Secretary under this subsection to
control a drug or other substance not previously scheduled, where the
Secretary has recommended the drug or other substance be placed in
schedule II, III, IV, or V, shall be commenced not later than 120 days
after receipt of written recommendations from the Secretary. The final
rule shall be issued not later than 60 days after the date on which
both the public comment period has closed and the drug or other
substance is the subject of an approved new drug application under
section 505 of the Federal Food, Drug, and Cosmetic Act, unless a
hearing on the proposed rule is granted by the Attorney General.''.
SEC. 3. ENHANCING NEW DRUG DEVELOPMENT.
Section 303 of the Controlled Substances Act (21 U.S.C. 823) is
amended by adding at the end the following:
``(i)(1) For the purposes of registration to manufacture a controlled
substance under subsection (d) of this section for use only in a
clinical trial, the Attorney General shall register an applicant or
serve an order to show cause upon an applicant pursuant to section
304(c) of this Act not later than 180 days after receipt of an
application and all information the Attorney General deems necessary to
make a determination under subsection (d).
``(2) For the purposes of registration to manufacture a controlled
substance under subsection (a) for use only in a clinical trial, the
Attorney General shall, in accordance with regulations issued by the
Attorney General, issue a notice of application not later than 90 days
after receipt of an application and all information the Attorney
General deems necessary to issue a notice of application. Following the
close of the comment period and receipt of all information the Attorney
General deems necessary to make a determination under subsection (a),
the Attorney General shall register an applicant or serve an order to
show cause upon an applicant pursuant to section 304(c) of this Act
within 180 days, unless a hearing on the application has been granted
by the Attorney General pursuant to section 1008(i) of the Controlled
Substances Import and Export Act.''.
Purpose and Summary
H.R. 4299 improves patient access to new and innovative
medications by streamlining the process for scheduling new
drugs under the Controlled Substances Act (CSA). H.R. 4299 also
amends the Drug Enforcement Administration's (DEA) approval
process for drugs to be used in clinical trials by requiring
that, for the purposes of a DEA registration to manufacture or
distribute a controlled substance for use only in connection
with clinical trials, the DEA must either register the
manufacturer for the purposes of a clinical trial or serve an
order to show cause on the applicant within 180 days.
Background and Need for the Legislation
Under current law, drugs and substances that have not been
marketed previously in the United States and that have the
potential for abuse and/or dependency must be approved by the
Food and Drug Administration (FDA), and also must be scheduled
under the CSA by the DEA before a company can begin marketing
its product.
During FDA's approval process, the agency examines the
abuse and dependency potential of the new drug and makes a
scheduling recommendation through the Secretary of HHS to the
DEA (through the Attorney General). In formulating its
recommendations, FDA conducts an eight-part test outlined in
Section 201(c) of the CSA.\1\ There is no time limit on the FDA
approval process. Once it receives the FDA's report and
recommendations, the DEA also utilizes the eight-part test in
Section 201(c) to conduct its review. FDA's decisions related
to scientific and medical matters\2\ are binding on the DEA,
but FDA's scheduling recommendation is only a recommendation,
which DEA must consider in its independent determination. In
recent years, some companies have complained that the length of
time DEA has taken in its scheduling decisions has delayed
their product launches, which has denied patients access to the
new therapies. As amended, H.R. 4299 requires that, for drugs
that FDA has recommended be placed in Schedules II, III, IV,
and V, DEA must initiate the scheduling process not later than
120 days after it receives the FDA's analysis and
recommendations. It also requires that the DEA issue a final
rule not later than 60 days after the date on which both the
public comment period has closed and the FDA has approved the
drug.
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\1\21 U.S.C. Sec. 811(c).
\2\See 21 U.S.C. Sec. 811(c)(2) and (3).
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H.R. 4299 also amends the DEA approval process for drugs to
be used in clinical trials, because there have been complaints
from the pharmaceutical industry that DEA has taken too much
time to make scheduling decisions for drugs to be used only in
clinical trials. It would do this by requiring that, for the
purposes of a DEA registration to manufacture or distribute a
controlled substance for use only in connection with clinical
trials, the DEA must either register the manufacturer for the
purposes of a clinical trial or serve an order to show cause on
the applicant within 180 days. H.R. 4299 also provides that
this time period does not begin until the application and all
necessary information is submitted to DEA, which includes the
notice and comment period required under the regulations for
applications to manufacture Schedule I or II drugs.
Hearings
The Committee on the Judiciary held no hearings on H.R.
4299.
Committee Consideration
On September 10, 2014, the Committee met in open session
and ordered the bill H.R. 4299 favorably reported with an
amendment, by voice vote, a quorum being present.
Committee Votes
In compliance with clause 3(b) of rule XIII of the Rules of
the House of Representatives, the Committee advises that there
were no recorded votes during the Committee's consideration of
H.R. 4299.
Committee Oversight Findings
In compliance with clause 3(c)(1) of rule XIII of the Rules
of the House of Representatives, the Committee advises that the
findings and recommendations of the Committee, based on
oversight activities under clause 2(b)(1) of rule X of the
Rules of the House of Representatives, are incorporated in the
descriptive portions of this report.
New Budget Authority and Tax Expenditures
Clause 3(c)(2) of rule XIII of the Rules of the House of
Representatives is inapplicable because this legislation does
not provide new budgetary authority or increased tax
expenditures.
Congressional Budget Office Cost Estimate
In compliance with clause 3(c)(3) of rule XIII of the Rules
of the House of Representatives, the Committee sets forth, with
respect to the bill, H.R. 4299, the following estimate and
comparison prepared by the Director of the Congressional Budget
Office under section 402 of the Congressional Budget Act of
1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, September 17, 2014.
Hon. Bob Goodlatte, Chairman,
Committee on the Judiciary,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 4299, the
``Improving Regulatory Transparency for New Medical Therapies
Act.''
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Mark
Grabowicz, who can be reached at 226-2860.
Sincerely,
Douglas W. Elmendorf,
Director.
Enclosure
cc:
Honorable John Conyers, Jr.
Ranking Member
H.R. 4299--Improving Regulatory Transparency for
New Medical Therapies Act.
As ordered reported by the House Committee on the Judiciary
on September 10, 2014.
H.R. 4299 would modify the administrative procedures
followed by the Department of Justice in regulating new drugs
that are already approved by the Food and Drug Administration
and in authorizing drugs to be used in clinical trials. The
legislation would aim to streamline the current review and
approval process. CBO estimates that implementing the bill
would have no significant costs to the Federal Government.
Enacting the legislation would not affect direct spending or
revenues; therefore, pay-as-you-go procedures do not apply.
H.R. 4299 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act and
would impose no costs on state, local, or tribal governments.
On June 26, 2014, CBO transmitted a cost estimate for H.R.
4299 as ordered reported by the House Committee on Energy and
Commerce on June 10, 2014. The cost estimates are the same.
The CBO staff contact for this estimate is Mark Grabowicz.
The estimate was approved by Theresa Gullo, Deputy Assistant
Director for Budget Analysis.
Duplication of Federal Programs
No provision of H.R. 4299 establishes or reauthorizes a
program of the Federal Government known to be duplicative of
another Federal program, a program that was included in any
report from the Government Accountability Office to Congress
pursuant to section 21 of Public Law 111-139, or a program
related to a program identified in the most recent Catalog of
Federal Domestic Assistance.
Disclosure of Directed Rule Makings
The Committee estimates that H.R. 4299 specifically directs
to be completed no specific rule makings within the meaning of
5 U.S.C. 551.
Performance Goals and Objectives
The Committee states that pursuant to clause 3(c)(4) of
rule XIII of the Rules of the House of Representatives, H.R.
4299 streamlines the process for scheduling new drugs under the
Controlled Substances Act.
Advisory on Earmarks
In accordance with clause 9 of rule XXI of the Rules of the
House of Representatives, H.R. 4299 does not contain any
congressional earmarks, limited tax benefits, or limited tariff
benefits as defined in clause 9(e), 9(f), or 9(g) of Rule XXI.
Section-by-Section Analysis
The following discussion describes the bill as reported by
the Committee.
Sec. 1. Short title. Section 1 sets forth the short title
of the bill as the Improving Regulatory Transparency for New
Medical Therapies Act.
Sec. 2. Scheduling of Substances Included in New FDA-
Approved Drugs. Section 2 imposes a statutory timeline on DEA
for scheduling new drugs. Specifically, it requires that for
drugs that FDA has recommended be placed in Schedules II, III,
IV, and V, DEA initiate the scheduling process not later than
120 days after it receives the FDA's analysis and
recommendations. It also requires that the DEA issue a final
rule not later than 60 days after the date on which both the
public comment period has closed and the FDA has approved the
drug. Though it imposes new statutory timelines on DEA, H.R.
4299 as reported maintains DEA's existing statutory authority
to conduct its own analysis of drugs for scheduling purposes,
as required under 21 U.S.C. 811(c), and preserves the authority
of the Attorney General to schedule a drug in his discretion,
as required in 21 U.S.C. 811(a).
Sec. 3. Enhancing New Drug Development. Section 3 requires
DEA to either register a manufacturer for the purposes of a
clinical trial or serve an order to show cause on the applicant
within 180 days. Section 3 also provides that this time period
does not begin until the application and all necessary
information is submitted to DEA, which includes the notice and
comment period required under the regulations for applications
to manufacture Schedule I or II drugs.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (new matter is
printed in italics and existing law in which no change is
proposed is shown in roman):
CONTROLLED SUBSTANCES ACT
TITLE II--CONTROL AND ENFORCEMENT
short title
Sec. 100. This title may be cited as the ``Controlled
Substances Act''.
* * * * * * *
Part B--Authority To Control; Standards and Schedules
authority and criteria for classification of substances
Sec. 201. (a) The Attorney General shall apply the
provisions of this title to the controlled substances listed in
the schedules established by section 202 of this title and to
any other drug or other substance added to such schedules under
this title. Except as provided in subsections (d) and (e), the
Attorney General may by rule--
(1) * * *
* * * * * * *
Rules of the Attorney General under this subsection shall be
made on the record after opportunity for a hearing pursuant to
the rulemaking procedures prescribed by subchapter II of
chapter 5 of title 5 of the United States Code. Proceedings for
the issuance, amendment, or repeal of such rules may be
initiated by the Attorney General (1) on his own motion, (2) at
the request of the Secretary, or (3) on the petition of any
interested party. Any such proceedings initiated at the request
of the Secretary under this subsection to control a drug or
other substance not previously scheduled, where the Secretary
has recommended the drug or other substance be placed in
schedule II, III, IV, or V, shall be commenced not later than
120 days after receipt of written recommendations from the
Secretary. The final rule shall be issued not later than 60
days after the date on which both the public comment period has
closed and the drug or other substance is the subject of an
approved new drug application under section 505 of the Federal
Food, Drug, and Cosmetic Act, unless a hearing on the proposed
rule is granted by the Attorney General.
* * * * * * *
Part C--Registration of Manufacturers, Distributors, and Dispensers of
Controlled Substances; Piperidine Reporting
* * * * * * *
registration requirements
Sec. 303. (a) * * *
* * * * * * *
(i)(1) For the purposes of registration to manufacture a
controlled substance under subsection (d) of this section for
use only in a clinical trial, the Attorney General shall
register an applicant or serve an order to show cause upon an
applicant pursuant to section 304(c) of this Act not later than
180 days after receipt of an application and all information
the Attorney General deems necessary to make a determination
under subsection (d).
(2) For the purposes of registration to manufacture a
controlled substance under subsection (a) for use only in a
clinical trial, the Attorney General shall, in accordance with
regulations issued by the Attorney General, issue a notice of
application not later than 90 days after receipt of an
application and all information the Attorney General deems
necessary to issue a notice of application. Following the close
of the comment period and receipt of all information the
Attorney General deems necessary to make a determination under
subsection (a), the Attorney General shall register an
applicant or serve an order to show cause upon an applicant
pursuant to section 304(c) of this Act within 180 days, unless
a hearing on the application has been granted by the Attorney
General pursuant to section 1008(i) of the Controlled
Substances Import and Export Act.
* * * * * * *