[Congressional Record Volume 164, Number 97 (Tuesday, June 12, 2018)]
[House]
[Pages H5031-H5032]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                              {time}  1430
         BETTER PAIN MANAGEMENT THROUGH BETTER DATA ACT OF 2018

  Mr. WALDEN. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 5473) to direct the Secretary of Health and Human Services 
to update or issue one or more guidances addressing alternative methods 
for data collection on opioid sparing and inclusion of such data in 
product labeling, and for other purposes, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 5473

       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 ``Better Pain Management 
     Through Better Data Act of 2018''.

     SEC. 2. GUIDANCE ADDRESSING ALTERNATIVE APPROACHES TO DATA 
                   COLLECTION AND LABELING CLAIMS FOR OPIOID 
                   SPARING.

       (a) In General.--For purposes of assisting sponsors in 
     collecting and incorporating opioid-sparing data in product 
     labeling, the Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary'') shall 
     conduct a public meeting and update or issue one or more 
     guidances in accordance with subsection (b).
       (b) Guidance.--
       (1) In general.--The Secretary of Health and Human 
     Services, acting through the Commissioner of Food and Drugs, 
     shall update or issue one or more guidances addressing--
       (A) alternative methods for data collection on opioid 
     sparing;
       (B) alternative methods for inclusion of such data in 
     product labeling; and
       (C) investigations other than clinical trials, including 
     partially controlled studies and objective trials without 
     matched controls such as historically controlled analyses, 
     open-label studies, and meta-analyses, on opioid sparing for 
     inclusion in product labeling.
       (2) Contents.--The guidances under paragraph (1) shall 
     address--
       (A) innovative clinical trial designs for ethically and 
     efficiently collecting data on opioid sparing for inclusion 
     in product labeling;
       (B) primary and secondary endpoints for the reduction of 
     opioid use while maintaining adequate pain control;
       (C) use of real world evidence, including patient 
     registries, and patient reported outcomes to support 
     inclusion of opioid-sparing data in product labeling; and
       (D) how sponsors may obtain feedback from the Secretary 
     relating to such issues prior to--
       (i) commencement of such data collection; or
       (ii) the submission of resulting data to the Secretary.
       (3) Public meeting.--Prior to updating or issuing the 
     guidances required by paragraph

[[Page H5032]]

     (1), the Secretary shall consult with stakeholders, including 
     representatives of regulated industry, academia, patients, 
     and provider organizations, through a public meeting to be 
     held not later than 12 months after the date of enactment of 
     this Act.
       (4) Timing.--The Secretary shall--
       (A) not later than 12 months after the date of the public 
     meeting required by paragraph (3), update or issue the one or 
     more draft guidances required by paragraph (1); and
       (B) not later than 12 months after the date on which the 
     public comment period for such draft guidances closes, 
     finalize such guidances.
       (c) Definition.--In this section:
       (1) The terms ``opioid sparing'' and ``opioid-sparing'' 
     refer to the use of drugs or devices (as defined in section 
     201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     321)) that reduce pain while enabling the reduction, 
     replacement, or avoidance of oral opioids.
       (2) The term ``Secretary'' means the Secretary of Health 
     and Human Services.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Oregon (Mr. Walden) and the gentleman from New Jersey (Mr. Pallone) 
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 
have 5 legislative days in which to revise and extend their remarks and 
insert extraneous materials in 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 rise today to speak in favor of this legislation, and 
I want to thank Representatives Comstock and Lujan for their leadership 
on it.
  This bill would take steps to facilitate the development of products 
that reduce, replace, or prevent the use of opioids. Specifically, this 
legislation will direct the FDA to hold a public meeting and update the 
agency's guidance on opioid sparing data that can be used to support 
updated product labeling and claims.
  For many Americans, Mr. Speaker, dealing with chronic or acute pain, 
there are limited alternatives to opioids, but for some patients, there 
may be therapeutic alternatives which do not share the same risks 
inherent in opioid use. This bill will facilitate the process of 
getting information to providers and patients at a critical juncture in 
their treatment.
  By reducing the need to start an opioid, we can stop addiction before 
it starts, and we can save countless lives in the process. So I urge my 
colleagues to vote in favor of this narrowly tailored, commonsense, and 
noncontroversial measure.
  Mr. Speaker, I reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise in support of H.R. 5473, legislation offered by 
my colleagues, Representatives Lujan and Comstock.
  H.R. 5473 would provide greater clarity to drug and device 
manufacturers regarding the studies that should be conducted for 
purposes of making claims on the labeling of medical products that they 
may replace, delay, or reduce the use of opioids.
  This is practical legislation, Mr. Speaker, that I believe will help 
to encourage manufacturers to do the necessary work to determine how we 
can identify for providers and patients medical products that can serve 
as alternatives to the use of opioids for purposes of pain treatment.
  Mr. Speaker, I urge my colleagues to vote in support of H.R. 5473, 
and I reserve the balance of my time.
  Mr. WALDEN. Mr. Speaker, I have no other speakers on this 
legislation, and I reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I yield such time as he may consume to the 
gentleman from New Mexico (Mr. Ben Ray Lujan), who is one of the 
sponsors of this bill.
  Mr. BEN RAY LUJAN of New Mexico. Mr. Speaker, I rise in support of 
the Better Pain Management Through Better Data Act.
  Current data collection models used by the Food and Drug 
Administration to measure clinical effectiveness are not ideally suited 
to accelerate development of opioid-sparing products. This bipartisan 
legislation will better allow the FDA to obtain the data they need to 
more quickly approve label claims for nonaddictive pain medications.
  I think I have said this at least 100 times at this point, but we 
must work with our pharmaceutical partners and the FDA to make sure 
that patients across the country have nonaddictive pain management 
options.
  I come from a blue-collar district with ironworkers and ranchers and 
a whole lot of jobs where wear and tear on the body is inevitable. It 
is simply unrealistic to think that we won't have people who need 
access to pain therapy. That is where nonaddictive therapies come in. 
This bill is another step forward in making sure that everyone has more 
options to treat pain.
  While we are talking about nonaddictive pain medications and how 
important they are to break the cycle of addiction back home, I want to 
take a second to direct my comments toward all the pharmaceutical 
manufacturers who are developing or plan to develop drugs in this 
space: This is important. We need you to be innovative, and we need you 
to be aggressive.
  That being said, Mr. Speaker, I am already starting to be concerned 
regarding the cost of these drugs. Let me put this in plain English. I 
am worried that the people living in different parts of America may be 
able to afford these drugs but families who are struggling and worrying 
about how to make that family budget work are going to be left out. If 
people can't afford these therapies and these treatments, they are not 
going to make a bit of difference.
  We cannot create another layer of people who can afford medications 
and therapies and people who cannot, especially not when this issue is 
so important. All nonaddictive pain medications must be affordable, 
accessible, and of high quality.
  I appreciate the hard work of the committee staff, Chairman Walden, 
Ranking Member Pallone, and all the stakeholders who helped get this 
bill to the finish line.
  This epidemic is affecting too many New Mexicans, too many Americans, 
to not think about long-term strategies for preventing opioid use 
disorder in the future.
  I appreciate Chairman Walden's remarks. I thank him for acknowledging 
that this is not the end of our work.
  This committee has much work to do not just with this package, but 
into the future, until we are able to help everyone who is fighting 
addiction in America. I look forward to working with our colleagues, 
with the administration, and with anyone and everyone out there to make 
a difference when it comes to addiction in our country.
  Mr. WALDEN. Mr. Speaker, I have no further speakers on this 
legislation. I urge my colleagues to support it.
  I commend the gentleman from New Mexico (Mr. Ben Ray Lujan) and the 
gentlewoman from Virginia (Mrs. Comstock) for their tireless work on 
this legislation.
  Mr. Speaker, I urge my colleagues to vote in favor of it, and I yield 
back the balance of my time.
  Mr. PALLONE. Mr. Speaker, I also ask that my colleagues support this 
bipartisan legislation, and I yield back the balance of my time.
  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. 5473, 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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