WASHINGTON – U.S. Rep. Joe Barton, R-Texas, ranking member of the House Energy and Commerce Committee, issued the following statement today as part of committee markup of H.R. 6432, the Animal Drug User Fee Amendments of 2008, H.R. 6433, the Animal Generic Drug User Fee Act of 2008 and H.R. 2851, Michelle’s Law:
“Mr. Chairman, thank you for holding this markup on the Animal Drug User Fee Act, Animal Generic Drug User Fee Act and Michelle’s Law.
“We have the very famous ADUFA bill and also the AGDUFA bill and Michelle’s Law.
“In terms of animal drug user fees, the bill before us today, the ADUFA bill, is very important. It takes quite a bit of time to develop animal drugs and it also takes quite a bit of money. ADUFA was first authorized in 2003 – I think both you and I agree it’s been a success. There have been many new drugs for animals that have come forward because of that and they have come to market more quickly and safely.
“The authorization bill before us today provides an additional $98 million for the FDA via user fees for product review for FY2009 to 2013. As you said in your opening statement, if we don’t do anything, this program would expire at the end of this fiscal year and the FDA would lose its authority to collect user fees. I hope that we’re going to pass a clean bill today and I’m told that your staff and my staff have agreed to do that.
“I’m also going to support the passage of the Animal Generic Drug User Fee Act. For the first time, Congress will be creating a user fee program to speed up the approval of generic drugs for the animals, which I think is very important. It should decrease approval times for those types of drugs and also allow the approval process to be done in a more efficient and cost-effective fashion.
“Finally, we’re going to consider H.R. 2851, Michelle’s Law. As I mentioned last week, this bill would help college students who lose their full-time status due to a serious illness by allowing them to continue their coverage for up to a year. I understand that. I have three children who graduated from college and I have a step-daughter who’s currently in college, so I understand the value of that.
“There is going to be a little bit of an issue on Michelle’s Law. Congressman Burgess has an amendment dealing with coverage for motorcycle riders and ATV riders. The parliamentarians, as you know, have indicated that somehow that’s not germane even though it’s in the same section of the federal code that we’re passing Michelle’s Law on. The parliamentarians have indicated that the primary jurisdictional decision is for a college student which, if that were truly the case, would put this bill in the Education and Labor Committee, not the Energy and Commerce Committee. So at the appropriate time, Mr. Burgess is going to offer his amendment and I would encourage you to listen very carefully and hopefully either rule that the amendment is germane or at least tell us how we can work together to make his amendment in some fashion part of the bill.
“With that, Mr. Chairman, I look forward to the markup and I yield back.”
