POSTAPPROVAL STUDY REQUIREMENTS FOR CERTAIN CONTROLLED SUBSTANCES; Congressional Record Vol. 164, No. 102
(House of Representatives - June 19, 2018)

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[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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