Food and Drug Administration Amendments Act of 2007

FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007 -- (Extensions of Remarks - September 20, 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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