Moran Opening Statement on FY16 Budget Request for the U.S. Food and Drug Administration

WASHINGTON, D.C. – U.S. Senator Jerry Moran (R-Kan.), Chairman of the Senate Agriculture, Rural Development, and Food and Drug Administration Appropriations Subcommittee, today offered the following opening statement as part of a subcommittee hearing to review the FY2016 budget request for the U.S. Food and Drug Administration:
Chairman Jerry Moran Opening Statement
Committee on Appropriations
Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies
“Hearing to review the Fiscal Year 2016 funding request and budget justification
 for the U.S. Food and Drug Administration”
March 12, 2015
This hearing will come to order. Good morning. Today’s hearing will focus on the Food and Drug Administration’s (FDA) fiscal year 2016 budget request, and thank you Commissioner Hamburg, Mr. Tootle, and Mr. Cochran for being here today to discuss FDA’s priorities for the upcoming year. Dr. Hamburg, with this being your last appearance before the subcommittee as FDA Commissioner, I want to thank you for your public service and your efforts to promote the health and safety of American consumers. 
The agency you head has authority over approximately 20 cents of every dollar spent in America. Americans expect that the food they eat and the drugs they take will be safe and effective. FDA’s reach is vast; the agency has authority over more than 300,000 foreign establishments and 185,000 domestic establishments, ranging from food processing plants to facilities that manufacture lifesaving medications. In addition to facilities themselves, FDA is tasked with the regulatory responsibility of individual products. Just last week, FDA approved the first biosimilar product in the United States, enabling access to important therapies for patients in chemotherapy and other cancer treatments.
In delivering these regulatory responsibilities, your private sector partners expect transparency and certainty from FDA. When I speak to small businesses and agricultural producers in Kansas, their overwhelming concern is a government that limits their ability to create jobs and stifles innovation through unnecessary and burdensome regulations. We must always be mindful of these concerns.
Over the past four years, FDA has been given significant new responsibilities through the Food Safety Modernization Act, menu labeling legislation, and drug compounding legislation. 
When implementing these laws, FDA must avoid the trappings of “one-size-fits-all” solutions. Small businesses suffer under this practice all too frequently because they have limited capital to respond to significant new requirements and little time to implement these changes. 
The agency’s final rule on menu labeling is overly broad and inflexible and lacks a great deal of business practicality. I was disappointed to see the inclusion of grocery stores, convenience stores, and other entities that do not sell restaurant style food as their primary business. 
Under the Food Safety Modernization Act, FDA is tasked with implementing the most sweeping changes to food safety laws in over 70 years. I was pleased that the Agency took many of the concerns within the agricultural community into account by re-proposing significant portions of the rules because they were unworkable for farmers. With the court-mandated deadlines for finalization approaching, I encourage FDA to consider deliberate and thoughtful implementation of the law.
I look forward to discussing this and other topics with our witnesses today. We have a lot to cover this morning, so I will turn it over to Senator Merkley for his opening remarks.