U.S. Congressman Michael C. Burgess, M.D. 26th District of Texas

Subcommittee on Health Hearing re: Discussion Draft of the ‘Food and Drug Administration Globalization Act’ Legislation: Device and Cosmetic Safety Provisions


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WASHINGTON, DC, May 15 -

Thank you Mr. Chairman, I want to thank the Chairman of the full Committee Mr. Dingell for his draft of the FDA Globalization legislation. I do wish that there could have been more input from the minority side. I understand I am relatively new but it seems like if we could be present while your were drafting the draft it would be easier to get to a true bipartisan compromise. But never the less, I am grateful for this comment and review period. We’ve got a lot of work to do but I believe that this committee sincerely wants this to be bipartisan legislation and I stand ready to offer my assistance to make this a reality. Obviously I can not agree with all of the provisions in the Chairman’s FDA Globalization Act, I do welcome the honest and open discussion about the legislation that will transform the system.

This year, subcommittees on Energy and Commerce have had hearing after hearing after hearing regarding the resources or lack thereof of the Food and Drug Administration. We’ve also had many important investigations – the heparin issue, the melamine issue, the ongoing investigation of lead in dental devices. But while I sit on the health subcommittee, oversight and investigations subcommittee, commerce, trade and consumer protection, I can not recall any discussion or any investigation regarding the cosmetic industry. So I’m sure that there are some reforms that need to made within the Office of Cosmetics and Colors in the Center for Food Safety and Applied Nutrition, but I would urge this subcommittee to move methodically and deliberately. We shouldn’t just be passing legislation because we happen to be here.

I would like to address the issue of resources. I respect the fact that this bill attempts to garner more resources for the agency, but I do question some of the attempts. We all know the Food and Drug Administration, which should be the premier federal agency, has been under funded for decades. It’s many administrations, both Republican and Democratic; it’s many Congress’, both Republican and Democratic that bear responsibility for this problem. But this bill seeks to solve that by imposing a pass-through tax to consumers, disguised in the form of user-fees.

Mr. Chairman, I call on the leadership of this Committee, the leadership of the Appropriations Committee, the Speaker of the House to come together and develop a plan to get the critical resources to this important agency. This is an authorization bill. Under the best of circumstances, when do we expect to see one dime delivered to the Food and Drug Administration. Yet we can do that through the appropriations process this year if we will simply pay attention to the process. This committee doesn’t appropriate money, but every single member of this committee knows that this year we will be lucky if we pass one appropriations bill. Chances are most appropriations will be a passed through on a continuing resolution, and so the agency will receive level funding yet for another year.

Consequently, unless we take immediate steps to work within the Appropriations process, the Food and Drug Administration will continue to be under funded, regardless of the number of hearings that we hold at the subcommittee level.

So we must act. We must act methodically and deliberately. And Mr. Chairman you’ve been generous so I yield back the balance of my time.

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