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

Committee on Energy and Commerce markup of 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 16, 2008

Today the Committee will consider three important bills, and I am pleased that all of them have broad, bipartisan support. I commend Congressman Hodes for his leadership on the first bill before us, H.R. 2851, “Michelle’s Law”, and I commend Chairman Pallone and Ranking Members Barton and Deal for working closely with me on all of the bills we will consider today, as is the tradition of this Committee.

H.R. 2851, “Michelle’s Law”, would ensure that students who are covered by their parents’ health insurance do not lose that coverage if they become ill and are forced to take a medically necessary leave of absence from their studies. 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.

H.R. 6432, the “Animal Drug User Fee Amendments of 2008”, 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 the level of revenues, providing greater transparency, and setting specific timeframes by which data must be submitted to the FDA.

The Animal Drug User Fee Act expires on October 1, 2008, less than three months from now. I am pleased the Committee is on track to complete the reauthorization in time to avoid any personnel disruptions at the FDA.

Subcommittee Chairman Pallone will offer an amendment to H.R. 6432 that makes a series of technical and conforming changes. Additionally, it takes a significant step toward addressing an important public health concern regarding the use of antimicrobial drugs in food-producing animals. This amendment has been negotiated among the Majority, the Minority, and the FDA. I commend everyone for their hard work and cooperation, and I especially thank Representatives Matheson, Waxman, Pallone, Deal, and Barton for working together to reach agreement on this particular issue.

Finally, H.R. 6433, the “Animal Generic Drug User Fee Act of 2008”, is legislation similar to the existing Animal Drug user fee program. It has a specific focus, however, on expediting the application review process for new generic animal drugs.

As with the previous bills, Subcommittee Chairman Pallone will offer an amendment that makes a series of technical and conforming changes to the bill. These changes have also been developed among the Majority, the Minority, and the FDA.

A key component of both the Animal Drug and Animal Generic Drug user fee programs is providing FDA with the additional resources it needs to protect the public health. Throughout this Congress, the Committee has focused on the lack of resources at FDA and the potential consequences for the consuming public.

Addressing this deficiency remains one of the Committee’s highest priorities, and legislation I am drafting with Representatives Barton, Deal, Pallone, Shimkus, Stupak, and others, will modernize the FDA and significantly improve our food and drug safety system. I continue to solicit the support and input of all Members of the Committee on this critical legislation.

I encourage you to support these bills, and I reiterate my gratitude to Members on both sides of the aisle for working cooperatively, consistent with the finest traditions of this Committee.