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Hearing of the House Appropriations Committee Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies - Food and Drug Administration Budget Hearing


Location: Washington, DC

Mr. Chairman, thank you for yielding. Commissioner Hamburg, thank you for being with us today to discuss the Fiscal Year 2014 budget request for the Food and Drug Administration. In other subcommittee hearings, I've already lamented the fact that this budget request is woefully late and won't get our nation back on solid financial footing. But we will persevere.

Before I comment on your budget, let me begin by thanking you for FDA's recent decision that prohibits generic, crushable Oxycontin from coming to market without abuse deterrent technologies. Unfortunately drugs misused are a recipe for disaster, and advocates across the country salute you for your leadership in shepherding this landmark decision on generic painkillers.

As you know, the abuse of prescription drugs --particularly opioid pain pills -- is our nation's fastest growing drug threat, so great that your colleagues at the Centers for Disease Control have identified this crisis as an "epidemic." Just as FDA must responsibly address other epidemics like H1N1 and public health threats like meningitis from tainted steroid injections, you must also closely examine drugs entering or on the market including the prescribing patterns and potential abuse and diversion. Last week's decision by your agency will surely save lives and I hope it is a sign of things to come as it relates to our nation's very serious pain pill addiction.

Undoubtedly, the FDA is a critical partner in getting this multi-faceted health, law enforcement, patient access, and education issue under control. I am anxious to hear from you today about how we can build on this success story, and what other steps FDA can take to beat back on the abuse of prescription medications -- like rescheduling our most-widely prescribed and abused painkillers, hydrocodone combination drugs, and limiting the indication for prescribing these powerful opioids to "severe pain only."

Now to your budget request. Commissioner, the FDA is seeking nearly $4.7 billion, which is $622 million about the FY 13 level. I should note, however, that this request assumes that sequestration for FY 14 is undone -- far from a given considering the President's unwillingness to truly engage on discussions to address our real cost-drivers without talking about more taxes. Toward that end, this budget assumes the inclusion of six new user fees including one for registration of food facilities -- a fee likely to be passed onto consumers. As you can imagine, this Committee and the general public has little appetite for food fees. I am sure we will discuss this issue at length, as well as your recent comments about the effects of sequestration on food inspections, and the recent court order for FDA to move forward on the implementation of the Food Safety Modernization Act.

I look forward to hearing your testimony this morning, Commissioner.

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