[Congressional Record Volume 168, Number 158 (Thursday, September 29, 2022)]
[Senate]
[Pages S5514-S5515]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                       FDA MODERNIZATION ACT 2.0

  Mr. PAUL. Mr. President, I rise today to talk about a bill that would 
lift a mandate in the law dating back to the Great Depression. This 
mandate is that drugs have to be tested on animals before clinical 
trials in humans.
  This law was created back in the thirties--but I think makes no sense 
today--when the only methods we had back then were animal trials or 
human trials. But as the cofounder of a leading bioconvergence startup 
wrote in ``Forbes'' last December:

       [T]his legislation was passed 20 years before the first 
     modern blood tests, 40 years before [the] modern computers 
     and 60 years before the human genome was mapped. Now, we have 
     all these tools and so many more to evaluate and ensure the 
     safety of cosmetics and drug candidates before they reach 
     human trials.

  The problem is, the law never caught up to the science. The law 
perversely requires drug developers to test on animals, which often 
means killing them after the test is over, even when nonanimal methods 
would work better. Passing this bill will put a stop to the needless 
suffering and death of millions of animals in labs across the country.
  An emeritus neurology professor at Mayo Clinic, David Wiebers, wrote 
earlier this month in the Kansas City Star that the--

       [D]ifferences in genetics and physiology among species can 
     change the way a drug is metabolized in the body. As a 
     result, the predictive value of using animals for toxicity 
     testing is far from optimal. The intent of the 1938 
     requirement for animal models was to keep toxic drugs from 
     harming patients.

  A noble quest.

       Yet, statistics show that these animal tests are flawed and 
     misclassify many toxic compounds as safe.

  This partly explains why over 90 percent of drugs found to be safe in 
animal testing end up failing in human clinical trials. But animal 
tests can be more than twice as expensive--sometimes up to 30 times 
more expensive--as nonanimal alternatives. This is despite the fact 
that it takes over a decade to bring a new drug to market and costs 
about a billion dollars.
  You would think that if you are making that kind of investment, you 
would be getting something for your money. But not when the government 
gets in the way of progress.
  It is often said that the definition of insanity is doing the same 
thing over and over again and expecting a different result. We have 
mandated animal testing for the last 84 years, and it meant slower 
approval for promising drugs and cures.
  The time has come for the law to finally catch up with the science. I 
am glad the Senate has acted, and I hope the House of Representatives 
will now move quickly to pass this measure into law.
  This law will allow the option of not doing animal testing. It is not 
that it will forbid and prevent any animal testing; it simply will 
allow the option of bringing drugs to market without sacrificing 
animals if we don't need to.
  Mr. President, I ask unanimous consent that the Senate proceed to the 
immediate consideration of S. 5002, which is at the desk.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The clerk will report the bill by title.
  The legislative clerk read as follows:

       A bill (S. 5002) to allow for alternatives to animal 
     testing for purposes of drug and biological product 
     applications.

  There being no objection, the Senate proceeded to consider the bill.
  Mr. PAUL. I ask unanimous consent that the bill be considered read a 
third time and passed and that the motion to reconsider be considered 
made and laid upon the table.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The bill (S. 5002) was ordered to be engrossed for a third reading, 
was read the third time, and passed, as follows:

                                S. 5002

       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 ``FDA Modernization Act 2.0''.

     SEC. 2. ALTERNATIVES TO ANIMAL TESTING.

       (a) In General.--Section 505 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355) is amended--

[[Page S5515]]

       (1) in subsection (i)--
       (A) in paragraph (1)(A), by striking ``preclinical tests 
     (including tests on animals)'' and inserting ``nonclinical 
     tests''; and
       (B) in paragraph (2)(B), by striking ``animal'' and 
     inserting ``nonclinical tests''; and
       (2) after subsection (y), by inserting the following:
       ``(z) Nonclinical Test Defined.--For purposes of this 
     section, the term `nonclinical test' means a test conducted 
     in vitro, in silico, or in chemico, or a non-human in vivo 
     test that occurs before or during the clinical trial phase of 
     the investigation of the safety and effectiveness of a drug, 
     and may include animal tests, or non-animal or human biology-
     based test methods, such as cell-based assays, 
     microphysiological systems, or bioprinted or computer 
     models.''.
       (b) Biosimilar Biological Product Applications.--Item (bb) 
     of section 351(k)(2)(A)(i)(I) of the Public Health Service 
     Act (42 U.S.C. 262(k)(2)(A)(i)(I)) is amended to read as 
     follows:
       ``(bb) an assessment of toxicity (which may rely on, or 
     consist of, a study or studies described in item (aa) or 
     (cc)); and''.

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