[Congressional Record Volume 168, Number 98 (Wednesday, June 8, 2022)]
[Extensions of Remarks]
[Pages E599-E600]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                    FOOD AND DRUG AMENDMENTS OF 2022

                                 ______
                                 

                               speech of

                        HON. SHEILA JACKSON LEE

                                of texas

                    in the house of representatives

                         Tuesday, June 7, 2022

  Ms. JACKSON LEE. Madam Speaker, I rise in support of H.R. 7667, the 
``Food and Drug Amendments Act of 2022,'' which will reauthorize user 
fees for prescription drugs, medical devices, generic drugs, and 
biosimilar products from fiscal 2023 through 2027.
  Congress has successfully supported the reauthorization of this 
important legislation with bi-partisan support for over 80 years.
  We must continue in our efforts to generate guidance and regulation 
on the healthcare products and pharmaceutical drugs available to the 
American people we serve.
  Let it be known, however, that today, the 117th Congress brings 
forward new requirements of racial and cultural diversity.
  In addition to providing reauthorization for pharmaceutical drug, 
equipment, and trial funding, H.R. 7667 recognizes the millions of 
Americans who are racial and ethnic minorities who have been too long 
mistreated by medical trials and studies--to the detriment of our 
health.
  Today we add amendments to this Act that will ensure medical care 
reflects people across all groups so that we may receive healthcare 
that is developed and designed to serve us.
  The law that we are reauthorizing today will require pharmaceutical 
manufacturers to submit to the Secretary of Health and Human Services 
detailed Diversity Action Plans.
  These plans must outline their initiatives to include in clinical 
studies participants across various subgroups including: age, sex, 
geographic location, socio-economic status, ethnicity and race.
  America has an ugly history of racialized medical testing.

[[Page E600]]

  As I am sure many of you know, People of Color, Black people 
specifically, have been used and abused by the American medical system.
  White doctors once claimed that Black patients couldn't feel pain--so 
they used us as medical experiments.
  J. Marion Sims, the ``father of gynecology'' perfected his craft by 
repeatedly slicing open enslaved Black women for painful medical 
surgeries without anesthesia.
  On one unmedicated woman, he performed 30 surgeries.
  For forty years--until 1972--Black men in Tuskegee, Alabama were 
studied and experimented on without their consent.
  Out of 600 men, over 120 died from what was a treatable disease.
  In yesteryear, People of Color were treated as expendable research 
material.
  In recent times, we have been left out of medical trials entirely.
  When Moderna first began research for their life-saving COVID-19 
vaccine, it was discovered that Black participants made up only 7 
percent of their clinical trial despite making up twice that percentage 
nationally.
  This is not an isolated problem.
  Nationally, though People of Color make up about 39 percent of the 
U.S. population, we are represented by only 2 percent to 16 percent of 
patients in trials.
  Nearly 50 percent of the residents of Houston are People of Color.
  We are parents, children, siblings, and loved ones.
  We are front-line workers, educators, healthcare providers, and 
servicemen and women.
  We deserve more.
  We deserve better.
  We deserve to receive medications and to use life-saving medical 
tools that are designed and developed with the people's specific needs 
in mind.
  H.R. 7667 will work to rectify this inequity in the United States' 
Health Care system through mandatory Diversity Action Plans, 
Educational Workshops and Accountability Reports.
  In addition to its vital diversity initiatives, ``The Food and Drug 
Amendments Act of 2022'' establishes tools to seek out new and 
innovative technology to better meet the needs of the American people.
  The Secretary of Health and Human Services will establish National 
Centers of Excellence in Advanced and Continuous Pharmaceutical 
Manufacturing to design, develop, and implement better and more 
efficient pharmaceuticals.
  H.R. 7667 will accelerate the development of drugs needed in rapid 
response situations like the COVID-19 pandemic, supply chain 
disruptions, and other large scale medical emergencies.
  As we have learned over the last two and a half years of this 
pandemic, now is the time to prepare for whatever tomorrow might bring.
  These developments will help our healthcare system get ahead of 
national medical needs before they become crises.
  This Act will arm America with a strong medical foundation in 
technological and medical advancement for our future, and will 
encourage clinical trials that better represent the face of America.
  Madam Speaker, it is a privilege to continue in the decades long 
bipartisan support for the Federal Food, Drug, and Cosmetic Act and the 
amendments provided in ``The Food and Drug Amendments Act of 2022.''
  I urge my colleagues to join me in voting for H.R. 7667 to provide 
for a better and more equitable medical future for our country.

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