[Congressional Record Volume 168, Number 98 (Wednesday, June 8, 2022)]
[Extensions of Remarks]
[Pages E594-E595]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                    FOOD AND DRUG AMENDMENTS OF 2022

                                 ______
                                 

                               speech of

                           HON. ANNA G. ESHOO

                             of california

                    in the house of representatives

                         Tuesday, June 7, 2022

  Ms. ESHOO. Madam Speaker, I rise in full support of H.R. 7667, the 
Food and Drug Amendments Act of 2022 and I'm proud to sponsor this 
strong, bipartisan FDA user fee bill.
  Our nation is an international leader in biomedical innovation. With 
that achievement comes an increasingly complex FDA review process for 
drugs and devices. Over the past few decades, the user fee agreements 
have evolved to ensure the FDA has the resources necessary so its 
reviews for drugs and devices are prompt, transparent, and predictable. 
The agreements included in the bill before us today are the latest 
evolution, and will in total, provide billions of dollars to the FDA 
over the next five years, allowing FDA to hire hundreds of new full-
time employees. These resources will help the FDA recover from the 
pandemic and pick up its regular day-to-day work even more effectively.
  Beyond the user fee agreement, the bill includes several important 
legislative riders. It includes key portions of my bipartisan DEPICT 
Act, which I introduced with Representatives Kelly and Fitzpatrick. FDA 
data shows that for the drugs approved in 2020, 75 percent of clinical 
trial participants were white. Only 8 percent of trial participants 
were African American and 11 percent were Hispanic. The DEPICT Act 
included in the bill would statutorily require drug companies to 
demonstrate how they will include diverse populations in their clinical 
trials by reporting to FDA a ``diversity action plan'' with targets by 
demographic subgroups. As we heard from Dr. Mesa during our hearing, 
diverse clinical trials are not only fair and just--it's good science.
  H.R. 7667 also includes important reforms to the FDA's inspections 
program based on bills introduced by Representatives Griffith and 
Welch, as well as by myself and Representative Hudson. These provisions 
will help the FDA catch up from a two-year inspection backlog due to 
the pandemic and conduct a pilot program of unannounced foreign 
inspections.
  H.R. 7667 includes targeted reforms to improve the accelerated 
approval program so that drugs approved under that program ultimately 
show their clinical effectiveness.
  The bill reauthorizes the Best Pharmaceuticals for Children Act 
(BPCA), which I first authored in 1997. Thanks to BPCA and its partner, 
the Pediatric Research Equity Act, 900 drugs newly have pediatric use 
information.
  Overall, this is a very strong bill with many worthy reforms, and I 
encourage my colleagues to vote for it.

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