[Congressional Record (Bound Edition), Volume 153 (2007), Part 18]
[Extensions of Remarks]
[Page 25129]
[From the U.S. Government Publishing Office, www.gpo.gov]




          FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007

                                 ______
                                 

                           HON. MIKE THOMPSON

                             of california

                    in the house of representatives

                      Thursday, September 20, 2007

  Mr. THOMPSON of California. Mr. Speaker, I rise in support of H.R. 
3580, the Food and Drug Administration Amendments Act of 2007. This 
bill necessarily reauthorizes the Prescription Drug User Fee Program, 
the Medical Device User Fee Program, and Food and Drug Administration, 
FDA, authority to grant an additional 6 months marketing exclusivity to 
a manufacturer of a drug in return for FDA requested pediatric use, for 
5 years, through 2012. The act also addresses a variety of other issues 
of importance to the FDA and to the Nation regarding pediatric medical 
device safety and improvement, research equity, and pharmaceuticals, a 
foundation for the FDA, better ways to deal with potential conflicts of 
interest, clinical trial databases, and measures to increase the post-
market safety of drugs. All of these issues are important, but I 
believe that one of the most important sections of the bill regards 
additional steps to ensure the safety of our Nation's food.
  Mr. Speaker, today we live in a global community, exchanging goods 
and services with countries around the world. Every country is 
different, and possesses differing standards, quality assurance, public 
health infrastructures, safety testing capacity, and desire and ability 
to secure shipments and distribution systems. Additionally, each must 
deal with a unique set of threats--naturally caused and intentionally 
generated. Much of the food on America's dinner tables comes from 
beyond our borders, and as we all know, despite the best efforts of a 
small number of dedicated personnel, much of that food comes into the 
country without being inspected. Also, whether the food comes from 
outside or inside the United States, the distribution systems are 
largely unsecured. This legislation is a tremendous step forward--
increasing inspections, improving research, and giving FDA the 
necessary authorities to inspect, trace, quarantine, and recall certain 
imported food to ensure safety.
  Al Qaeda and other extremist organizations have indicated the desire 
to use agroterrorist means to attack our food supply. There is also 
increasing evidence to indicate that these organizations have been 
recruiting personnel with the scientific and technical know-how to 
accomplish these means. Additionally, over the past few decades, we 
have seen cases in the United States of intentional tampering of over-
the-counter pharmaceuticals and controlled substances, resulting in 
illness and death throughout the country.
  As the committee with oversight of the Department of Homeland 
Security, DHS, the Committee on Homeland Security works diligently to 
ensure that DHS effectively executes and manages its duties, and where 
appropriate, ensures that DHS works collaboratively with other Federal 
agencies. DHS, through Immigration and Customs Enforcement, often 
partners with FDA to investigate food and drug tampering and 
contamination cases. Customs and Border Protection, as well as the 
United States Coast Guard, also have roles in interdicting and 
inspecting contaminated shipments as they cross borders and seas into 
the country. I am pleased that this legislation requires the Secretary 
of Health and Human Services, HHS, to notify the Secretary of the 
Department of Homeland Security when an HHS entity believes food has 
been adulterated. Information-sharing is critical to effective, timely 
response to threats and a more secure homeland.
  This legislation addresses a number of important aspects regarding 
food and drug safety and security. Actions we take now to better secure 
our food and drugs against contamination, adulteration, and terrorism 
will add to our overall homeland and transnational security.
  I encourage my colleagues to pass this legislation with strong 
bipartisan support.

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