[Congressional Record Volume 164, Number 102 (Tuesday, June 19, 2018)]
[House]
[Pages H5243-H5244]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
POSTAPPROVAL STUDY REQUIREMENTS FOR CERTAIN CONTROLLED SUBSTANCES
Mr. WALDEN. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 5811) to amend the Federal Food, Drug, and Cosmetic Act with
respect to postapproval study requirements for certain controlled
substances, and for other purposes, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 5811
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. POSTAPPROVAL STUDY REQUIREMENTS.
(a) Purposes of Study.--Section 505(o)(3)(B) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)(B)) is
amended by adding at the end the following:
``(iv) To assess a potential reduction in effectiveness of
the drug for the conditions of use prescribed, recommended,
or suggested in the labeling thereof if--
``(I) the drug involved--
``(aa) is or contains a substance for which a listing in
any schedule is in effect (on a temporary or permanent basis)
under section 201 of the Controlled Substances Act; or
``(bb) is a drug that has not been approved under this
section or licensed under section 351 of the Public Health
Service Act, for which an application for such approval or
licensure is pending or anticipated, and for which the
Secretary provides notice to the sponsor that the Secretary
intends to issue a scientific and medical evaluation and
recommend controls under the Controlled Substances Act; and
``(II) the potential reduction in effectiveness could
result in the benefits of the drug no longer outweighing the
risks.''.
(b) Establishment of Requirement.--Section 505(o)(3)(C) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(o)(3)(C)) is amended by striking ``such requirement'' and
all that follows through ``safety information.'' and
inserting the following: ``such requirement--
``(i) in the case of a purpose described in clause (i),
(ii), or (iii) of subparagraph (B), only if the Secretary
becomes aware of new safety information; and
``(ii) in the case of a purpose described in clause (iv) of
such subparagraph, if the Secretary determines that new
effectiveness information exists.''.
(c) Applicability.--Section 505(o)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)) is amended by
adding at the end the following new subparagraph:
``(G) Applicability.--The conduct of a study or clinical
trial required pursuant to this paragraph for the purpose
specified in subparagraph (B)(iv) shall not be considered a
new clinical investigation for the purpose of a period of
exclusivity under clause (iii) or (iv) of subsection
(c)(3)(E) or clause (iii) or (iv) of subsection (j)(5)(F).''.
(d) New Effectiveness Information Defined.--Section
505(o)(2) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(o)(2)) is amended by adding at the end the
following new subparagraph:
``(D) New effectiveness information.--The term `new
effectiveness information', with respect to a drug that is or
contains a controlled substance for which a listing in any
schedule is in effect (on a temporary or permanent basis)
under section 201 of the Controlled Substances Act, means new
information about the effectiveness of the drug, including a
new analysis of existing information, derived from--
``(i) a clinical trial; an adverse event report; a
postapproval study or clinical trial (including a study or
clinical trial under paragraph (3));
``(ii) peer-reviewed biomedical literature;
``(iii) data derived from the postmarket risk
identification and analysis system under subsection (k); or
``(iv) other scientific data determined to be appropriate
by the Secretary.''.
(e) Conforming Amendments With Respect to Labeling
Changes.--Section 505(o)(4) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(o)(4)) is amended--
(1) in subparagraph (A)--
(A) in the heading, by inserting ``or new effectiveness''
after ``safety'';
(B) by striking ``safety information'' and inserting ``new
safety information or new effectiveness information such'';
and
(C) by striking ``believes should be'' and inserting
``believes changes should be made to'';
(2) in subparagraph (B)(i)--
(A) by striking ``new safety information'' and by inserting
``new safety information or new effectiveness information'';
and
(B) by inserting ``indications,'' after ``boxed
warnings,'';
(3) in subparagraph (C), by inserting ``or new
effectiveness information'' after ``safety information''; and
(4) in subparagraph (E), by inserting ``or new
effectiveness information'' after ``safety information''.
(f) Rule of Construction.--Nothing in the amendments made
by this section shall be construed to alter, in any manner,
the meaning or application of the provisions of paragraph (3)
of section 505(o) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(o)) with respect to the authority of the
Secretary of Health and Human Services to require a
postapproval study or clinical trial for a purpose specified
in clauses (i) through (iii) of subparagraph (B) of such
paragraph (3) or paragraph (4) of such section 505(o) with
respect to the Secretary's authority to require safety
labeling changes.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Oregon (Mr. Walden) and the gentleman from Massachusetts (Mr. Kennedy)
each will control 20 minutes.
The Chair recognizes the gentleman from Oregon.
General Leave
Mr. WALDEN. Mr. Speaker, I ask unanimous consent that all Members may
have 5 legislative days in which to revise and extend their remarks and
insert extraneous materials into the Record on the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Oregon?
There was no objection.
Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I want to speak in favor of this bipartisan bill and
thank Representative McNerney and Representative Griffith for working
so hard to advance this important policy.
Currently, there are limited data on the long-term efficacy of
opioids, their increased addictive tendencies over time, and their
overall place in the treatment of pain. This legislation will enhance
the Food and Drug Administration's authorities and enforcement tools to
ensure timely post-marketing studies for chronically administered
opioids.
Collecting and analyzing data is the best way to ensure that patients
and physicians have access to evidence-based treatments. This bill will
advance our understanding of the science underlying long-term use of
opioids, and I encourage my colleagues to support its passage.
Mr. Speaker, I especially appreciate the work of the sponsors of this
bill, including Representative Griffith, who would be here with us to
speak in favor of this legislation but for traffic congestion on his
way back from his district that has detained him from getting here as
he had previously scheduled.
Mr. Speaker, I encourage my colleagues to support the bill, and I
reserve the balance of my time.
Mr. KENNEDY. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise in support of H.R. 5811, the Long-Term Opioid
Efficacy Act of 2018, authored by Representatives McNerney and
Griffith.
Despite the prevalent use of opioids today in combating pain, the
long-term
[[Page H5244]]
impacts of opioids and whether or not they are truly the most effective
treatment is still fairly unknown.
FDA Commissioner Gottlieb testified before the Energy and Commerce
Committee that many opioids have not been studied for chronic
administration and further studying could help address certain
questions. This includes the long-term efficacy of opioids and whether
opioids may contribute to increased addictive tendencies over time.
This legislation would help us better understand the long-term
impacts of opioids and whether opioids truly are the most effective
treatment for chronic pain management by allowing the FDA to require
manufacturers of controlled substances, such as opioids, to conduct
post-market studies to assess the effectiveness of these products and
whether or not they pose an increase in serious risk.
{time} 1515
Under current law, the FDA has the authority to request postmarket
studies relating to the safety considerations of a drug, but it does
not have explicit authority to do so related to the efficacy of a drug.
It is our hope that, by granting this authority to the FDA, we will
better understand the long-term impacts of opioids that are chronically
administered and encourage more responsible prescribing of opioids
moving forward.
Mr. Speaker, I urge my colleagues to support this legislation, and I
yield back the balance of my time.
The SPEAKER pro tempore. Without objection, the gentleman from
Kentucky (Mr. Guthrie) will control the time for the majority.
There was no objection.
Mr. GUTHRIE. Mr. Speaker, I yield back the balance of my time.
Ms. JACKSON LEE. Mr. Speaker, I rise in strong support of H.R. 5811,
which amends the Federal Food, Drug, and Cosmetic Act with respect to
post approval study requirements for certain controlled substances.
H.R. 5811 allows the FDA to require that pharmaceutical manufacturers
study certain drugs after they are approved to assess any potential
reduction in those drugs' effectiveness for the conditions of use
prescribed, recommended, or suggested in labeling.
In recent years, many communities have been devastated by the number
of overdoses that have been related to the escalating opioid epidemic.
According to U.S. Department of Health and Human Services, illegal
substances, deadly synthetics such as fentanyl, and legally available
pain relievers accounted for more than 42,000 deaths across the country
in 2016.
Further, in the city of Houston, there were 364 drug-related overdose
deaths alone that happened in 2016 according to the Treatment Center, a
highly respected drug and alcohol addiction treatment service center.
This is a national emergency that deserves immediate action.
H.R. 5811 would expand an existing mandate that requires drug
developers to conduct post-approval studies or clinical trials for
certain drugs.
FDA will provide doctors and patients the information they need to
use medicines wisely.
This will ensure that drugs, both brand-name and generic, work
correctly and that their health benefits outweigh their known risks.
Under current law, in certain instances, the FDA can require studies
or clinical trials after a drug has been approved.
H.R. 5811 would permit the FDA to use that authority if the reduction
in a drug's effectiveness meant that its benefits no longer outweighed
its costs.
I urge my colleagues to join me in voting to pass H.R. 5811.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Oregon (Mr. Walden) that the House suspend the rules and
pass the bill, H.R. 5811, 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.
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