[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.
____________________