[Congressional Record Volume 168, Number 91 (Wednesday, May 25, 2022)]
[Senate]
[Pages S2709-S2710]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




          STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

By Mr. KAINE (for himself, Mr. Marshall, Ms. Hassan, and Mr. Cassidy):
  S. 4302. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
require prompt reports of marketing status by holders of approved 
applications for biological products, and for other purposes; to the 
Committee on Health, Education, Labor, and Pensions.
  Mr. KAINE. Mr. President, the Food and Drug Administration's ``Purple 
Book'' provides patients, providers, and public health experts with key 
information about FDA-licensed biological products. Providers rely on 
accurate and up-to-date information from this searchable online 
database to make crucial decisions regarding the treatment of their 
patients. The ``Purple Book'' provides transparency on the availability 
of biological products. This can help inform public health decision-
making and increase competition among manufacturers to lower prices. 
Improvements to the ``Purple Book'' clarifying when biological products 
leave the market would allow the FDA and the public to monitor the 
availability of these key medications.
  That is why I am proud to join my colleagues, Senators Marshall, 
Hassan, and Cassidy, in introducing the Biologics Market Transparency 
Act, legislation that would extend to biological products certain 
reporting and transparency requirements that already exist for small 
molecule drugs. This is the Senate companion to legislation introduced 
by Representatives Kathy Manning and Richard Hudson in the House. It 
would require manufacturers of biological products to confirm that 
their products listed in the ``Purple Book'' are available for sale. 
This bill would also require manufacturers to report to the Secretary 
of Health and Human Services when their products are withdrawn from the 
market. These updates to the ``Purple Book'' would provide patients and 
providers with real-time access to changes in drug availability, 
allowing physicians to make informed decisions about the best treatment 
for their patients. These changes would also improve the ability of the 
FDA to respond to and anticipate drug shortages.
  I look forward to working with my colleagues to pass these 
commonsense reforms to strengthen public health and increase 
transparency for patients and providers.
                                 ______
                                 
      By Mr. KAINE (for himself and Ms. Collins):
  S. 4303. A bill to provide for a period of exclusivity for first 
interchangeable biological products; to the Committee on Health, 
Education, Labor, and Pensions.
  Mr. KAINE. Mr. President, biologics, or complex large molecule drugs 
typically derived from living organisms, play a critical role in our 
healthcare system, treating a range of conditions such as diabetes, 
arthritis, and cancer. Yet spending on these products accounts for an 
alarming and significant portion of overall drug spending in the United 
States. In 2018, biologics accounted for 40 percent of spending on all 
prescription drugs, with spending on biologics growing twice as quickly 
as overall drug spending since 2015.
  Biosimilars are drugs that are highly similar to existing biologics, 
and interchangeable biosimilars are biosimilars that can be substituted 
for a biologic product without the intervention of a healthcare 
provider. Biosimilars and interchangeable biosimilars can play a 
significant role in reducing drug spending. For example, Medicare Part 
D spending for both beneficiaries and the program is less than spending 
on reference biologic products even as the use of biosimilars increases 
with increased availability. As of April 2022, there were 33 biosimilar 
products on the market including interchangeable

[[Page S2710]]

biosimilar products. Food and Drug Administration, FDA, approval of 
additional interchangeable biosimilars could provide patients with more 
treatment options, increase competition, and lower costs. We must take 
steps to provide clarity around the FDA's review process for 
interchangeable biosimilars to facilitate development of these 
products, bringing them to market faster.
  That is why I am proud to join my colleague, Senator Collins, in 
introducing the Interchangeable Biologics Clarity Act, legislation that 
would make key improvements in the FDA's review process for 
interchangeable biosimilars. Specifically, this bill would clarify the 
FDA's authority to tentatively approve a second or third 
interchangeable before the end of the first interchangeable's 
exclusivity period, allowing additional products to enter the market 
more efficiently when that exclusivity period ends. This legislation 
would also specify that two interchangeable biologics approved on the 
same day could share an exclusivity period. These provisions would 
allow the FDA to issue additional guidance around the review of 
interchangeable biologic products and ensure increased transparency 
about the exclusivity periods for interchangeable products.
  I look forward to working with my colleagues to pass these important 
improvements to the FDA's biosimilar review process that will increase 
patients' treatment options and help foster competition.

                          ____________________