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Pallone Statement at Health Markup of Animal Drug User Fee Bills & Michelle's Law


Location: Washington, DC


U.S. Rep. Frank Pallone, Jr. (D-NJ), Chairman of the House Energy and Commerce Subcommittee on Health, gave the following opening statement this morning at a subcommittee markup of H.R. 2851, Michelle's Law, H.R. 6432, the Animal Drug User Fee Amendments Act of 2008, and H.R. 6433, the Animal Generic Drug User Fee Act of 2008.

"Good morning. Today the Subcommittee is meeting to markup:

· H.R. 2851, Michelle's Law

· H.R. 6432, the Animal Drug User Fee Amendments of 2008

· H.R. 6433, the Animal Generic Drug User Fee Act of 2008

"Michelle's Law, was introduced by my colleague from New Hampshire, Representative Paul Hodes, in honor of Michelle Morse, a 20-year-old student who was attending Plymouth State University when she was diagnosed with colon cancer in December 2003.

"Michelle's doctors recommended that she leave school temporarily so she could undergo surgery and chemotherapy. Unfortunately, if Michelle followed her doctors' advice and dropped out of school to receive treatment, she would no longer be eligible for health coverage under her mother's insurance policy.

"The truth of the matter is that most college age students are only eligible to keep their parents' health insurance if they attend classes full time. Under most health care plans, when a student becomes seriously ill or is injured, he or she is unfortunately left with very few options. Students are forced into the difficult decision of continuing with a full time course load while they try to seek treatment or withdrawing and losing healthcare eligibility. No American should be faced with such a choice.

"Unfortunately, Michelle had to choose. Michelle and her family decided that she would remain in school full time while she received treatment for her cancer. After enduring a rigorous course load and successfully graduating, Michelle lost her battle with cancer in November of 2005.

"After Michelle's death, her mother decided that no other family should have to make the same tough decision. Thanks to her efforts, New Hampshire passed a law that allows full-time students to take a one-year medical leave of absence while maintaining their dependency status. The bill we are marking up today would afford the same protections under federally regulated health plans.

"In addition to Michelle's law, we are also marking up the Animal Drug User Fee Amendments Act of 2008. Prior to 2003, the Food and Drug Administration's (FDA's) review of animal drug submissions was taking over a year and a half to be completed. This obviously led to serious concerns that new and innovative pharmaceutical products were not making their way onto the marketplace in order to treat our nation's pets, as well as food animals that help sustain the nation's food supply.

"Accordingly, in 2003 Congress enacted the Animal Drug User Fee Act (ADUFA), which was modeled after the successful user fee programs for the review of human drug and medical device submissions. Like the user fee programs that preceded it, ADUFA authorized the FDA to collect fees to help ensure that the agency had the resources it needed to provide a timely review of animal drug applications.

"Under the bill being marked up today, the amount of fees collected for the review of animal drug submissions would increase from $15 million to $24 million over five years for a total of $98 million. Revenues would be derived from a mix of application, product, establishment and sponsor fees.

"In addition to the reauthorization of ADUFA, we are marking up the Animal Generic Drug User Fee Act of 2008, which would establish a new animal generic drug user fee. According to FDA, the average review time of an animal generic drug submission was 570 days in Fiscal Year 2007, in spite of a 180 day statutory requirement. At the end of last year, there was a recorded backlog of 446 submissions waiting for review and agency action.

"The bill before us would provide for the collection of user fees increasing annually from $4.8 million to $6 million over five years for a total of $27 million. These additional revenues are designed to help speed up the review process. By year five of the authorization period, most reviews of generic animal drug submissions should occur in 270 days or less, a substantial improvement over the time it is now taking FDA to conduct such reviews.

"In closing, I want to thank my Republican colleagues for working with us in a bipartisan fashion to move these bills forward in a timely manner. One thing we were not able to work out in time for today's markup, however, was an agreement on how to address the use of antibiotics in food animals for prophylactic and/or growth purposes.

"Based on the testimony we heard and the statements from members at last month's hearing on the Administration's ADUFA and AGDUFA proposals, there are significant concerns about the use of antibiotics in animal populations for non-therapeutic purposes and the threat these practices pose to human health. It is my hope that we can work together to address this public health threat as we move towards Full Committee.

"I now recognize our Ranking Member, Mr. Deal, for five minutes for the purpose of making an opening statement."

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