[Congressional Record Volume 167, Number 64 (Wednesday, April 14, 2021)]
[House]
[Pages H1754-H1755]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




             ADVANCING EDUCATION ON BIOSIMILARS ACT OF 2021

  Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the 
bill (S. 164) to educate health care providers and the public on 
biosimilar biological products, and for other purposes.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                                 S. 164

       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 ``Advancing Education on 
     Biosimilars Act of 2021''.

     SEC. 2. EDUCATION ON BIOLOGICAL PRODUCTS.

       Subpart 1 of part F of title III of the Public Health 
     Service Act (42 U.S.C. 262 et seq.) is amended by adding at 
     the end the following:

     ``SEC. 352A. EDUCATION ON BIOLOGICAL PRODUCTS.

       ``(a) Internet Website.--
       ``(1) In general.--The Secretary may maintain and operate 
     an internet website to provide educational materials for 
     health care providers, patients, and caregivers, regarding 
     the meaning of the terms, and the standards for review and 
     licensing of, biological products, including biosimilar 
     biological products and interchangeable biosimilar biological 
     products.
       ``(2) Content.--Educational materials provided under 
     paragraph (1) may include--
       ``(A) explanations of key statutory and regulatory terms, 
     including `biosimilar' and `interchangeable', and 
     clarification regarding the use of interchangeable biosimilar 
     biological products;
       ``(B) information related to development programs for 
     biological products, including biosimilar biological products 
     and interchangeable biosimilar biological products and 
     relevant clinical considerations for prescribers, which may 
     include, as appropriate and applicable, information related 
     to the comparability of such biological products;
       ``(C) an explanation of the process for reporting adverse 
     events for biological products, including biosimilar 
     biological products and interchangeable biosimilar biological 
     products; and
       ``(D) an explanation of the relationship between biosimilar 
     biological products and interchangeable biosimilar biological 
     products licensed under section 351(k) and reference products 
     (as defined in section 351(i)), including the standards for 
     review and licensing of each such type of biological product.
       ``(3) Format.--The educational materials provided under 
     paragraph (1) may be--
       ``(A) in formats such as webinars, continuing education 
     modules, videos, fact sheets, infographics, stakeholder 
     toolkits, or other formats as appropriate and applicable; and
       ``(B) tailored for the unique needs of health care 
     providers, patients, caregivers, and other audiences, as the 
     Secretary determines appropriate.
       ``(4) Other information.--In addition to the information 
     described in paragraph (2), the Secretary shall continue to 
     publish--
       ``(A) the action package of each biological product 
     licensed under subsection (a) or (k) of section 351; or
       ``(B) the summary review of each biological product 
     licensed under subsection (a) or (k) of section 351.
       ``(5) Confidential and trade secret information.--This 
     subsection does not authorize the disclosure of any trade 
     secret, confidential commercial or financial information, or 
     other matter described in section 552(b) of title 5.
       ``(b) Continuing Education.--The Secretary shall advance 
     education and awareness among health care providers regarding 
     biological products, including biosimilar biological products 
     and interchangeable biosimilar biological products, as 
     appropriate, including by developing or improving continuing 
     education programs that advance the education of such 
     providers on the prescribing of, and relevant clinical 
     considerations with respect to, biological products, 
     including biosimilar biological products and interchangeable 
     biosimilar biological products.''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New 
Jersey (Mr. Pallone) and the gentleman from Florida (Mr. Bilirakis) 
each will control 20 minutes.
  The Chair recognizes the gentleman from New Jersey.


                             General Leave

  Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days in which to revise and extend their remarks 
and include extraneous material on S. 164.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, the rising cost of prescription drugs continues to be a 
major issue for families all across the country. These costs are 
particularly daunting at a time when we are facing a severe economic 
downturn and the ongoing pandemic.
  We are committed to continuing to find solutions to make prescription 
drugs more affordable for the American people. One important way to 
help families out is to ensure they are aware of more affordable 
options, like biosimilars and generics. These are both cheaper options, 
but, unfortunately, utilization of these products continues to be too 
low here in the United States.
  The Advancing Education on Biosimilars Act of 2021 is commonsense 
legislation that will help provide patients and healthcare providers 
with greater information about biologics and biosimilars. To do this, 
the bill requires the FDA to establish a public website with 
educational materials, including what products are interchangeable, as 
well as how to report any adverse events.
  In addition, the bill would support the development of continuing 
education programs for healthcare providers about biologics. It is 
critical that healthcare providers and patients are aware of all of 
their options, and this legislation will certainly help do that.
  I am pleased to work with my colleagues in the Senate on this 
legislation, and I urge my colleagues to support the bill.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, I rise today in support of S. 164, the Advancing 
Education on Biosimilars Act.
  This bill is a bipartisan companion to H.R. 1873, championed in the 
House by Dr. Bucshon and Congressman Peters.
  This bill would require the FDA to maintain and operate an internet 
website to provide educational materials for healthcare providers, 
patients, and caregivers on biological products, including biosimilar 
products and interchangeable biosimilar products.
  It also would require the Department of Health and Human Services, 
HHS, to develop continuing education programs or to improve existing 
programs for healthcare providers, such as doctors and nurses, to 
promote a better understanding of biosimilar interchangeable products.
  By increasing awareness about available biosimilar products and 
providing educational resources for physicians

[[Page H1755]]

and patients about their benefits, we can increase adoption of these 
lower cost alternative therapies when appropriate and drive down drug 
costs for Americans across the country.
  Mr. Speaker, I urge support for this bipartisan effort to lower drug 
costs through the uptake of biosimilar products, and I reserve the 
balance of my time.

                              {time}  1315

  Mr. PALLONE. Mr. Speaker, I reserve the balance of my time.
  Mr. BILIRAKIS. Mr. Speaker, I yield such time as he may consume to 
the gentleman from Indiana (Mr. Bucshon), a great member of the Energy 
and Commerce Committee and a great resource for us nonphysicians.
  Mr. BUCSHON. Mr. Speaker, I would like to speak in support of S. 164, 
the Advancing Education on Biosimilars Act of 2021, which is the Senate 
companion of H.R. 1873, a bill that I introduced with my friend and 
colleague, Congressman Scott Peters from California.
  This bipartisan, bicameral bill will require FDA to create a public 
website to educate patients and providers about biological and 
biosimilar products.
  As new biological and biosimilar products become available, it is 
important that physicians have current information on these therapies 
in order to choose the best treatment for their patients.
  Availability of information and education on these new and complex 
treatments for providers and patients will lead to healthy competition 
in the biologic and biosimilar product space and ultimately help to 
lower the cost of these important drugs for patients.
  I urge my colleagues to support this bill, and I look forward to the 
President signing it into law.
  Mr. PALLONE. Mr. Speaker, I have no additional speakers.
  Mr. BILIRAKIS. Mr. Speaker, I urge everyone to vote to pass this bill 
so we can quickly make this law and get it to the President.
  Mr. Speaker, I yield back the balance of my time.
  Mr. PALLONE. Mr. Speaker, I also urge support for this bill, and I 
yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from New Jersey (Mr. Pallone) that the House suspend the 
rules and pass the bill, S. 164.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds 
being in the affirmative, the ayes have it.
  Mr. CLINE. Mr. Speaker, on that I demand the yeas and nays.
  The SPEAKER pro tempore. Pursuant to section 3(s) of House Resolution 
8, the yeas and nays are ordered.
  Pursuant to clause 8 of rule XX, further proceedings on this motion 
are postponed.

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