Statement of Congressman John D. Dingell, Chairman
Committee on Energy and Commerce

SUBCOMMITTEE ON HEALTH MARKUP ON H.R. 2851, “MICHELLE'S LAW”, H.R. 6432, THE “ANIMAL DRUG USER FEE AMENDMENTS of 2008” AND H.R. 6433, THE “ANIMAL GENERIC DRUG USER FEE ACT OF 2008”

July 9, 2008

Mr. Chairman, today we are considering three important pieces of legislation. I am pleased that all three bills before us have bipartisan support. I commend Congressman Hodes for his leadership on Michelle’s Law and Reps. Pallone, Barton and Deal for coming to agreement on all of the bills.

The first bill we will consider is H.R. 2851, “Michelle’s Law.” This bill would ensure that when students who are covered by their parents’ insurance become ill and are forced to take a medically necessary leave of absence from their studies, they do not lose health insurance coverage. H.R. 2851 would provide common-sense protection for these students. It enjoys the support of numerous groups ranging from the American Hospital Association and America’s Health Insurance Plans to the American Heart Association and the National Patient Advocate Foundation.

The next bill is H.R. 6432, the “Animal Drug User Fee Amendments of 2008”. This legislation reauthorizes a successful user-fee program that has allowed the Food and Drug Administration (FDA) to safely and efficiently review animal drugs. This legislation improves the existing program by increasing levels of fee revenues, providing greater transparency, and setting specific timeframes by which data must be submitted to the FDA.

The Animal Drug User Fee Act (ADUFA) expires on October 1, 2008, less than three months from now. It is the responsibility of this Committee and the Congress to ensure that the program is reauthorized in a timely manner to avoid any personnel disruptions at the FDA.

Finally, we will consider H.R. 6433, the “Animal Generic Drug User Fee Act of 2008” (AGDUFA). This legislation is similar in design to the ADUFA program, but with a specific focus on expediting the review of applications for new generic animal drugs.

A key component of both ADUFA and AGDUFA is providing FDA with the greater resources it needs. These bills provide FDA with the necessary structure and resources for the timely and thorough review of applications for brand-name and generic animal drugs alike. The user fees established for these programs supplement, not supplant, existing appropriations to FDA. It is imperative that those appropriations continue to provide the requisite funds to the Agency.

Again, Mr. Chairman, I thank you for your excellent work, and Ranking Members Deal and Barton for your assistance in producing this strong, bipartisan legislation.