06.20.17

Hoeven Chairs Hearing to Review FY18 FDA Budget Request, Priorities

WASHINGTON, D.C. – U.S. Senator John Hoeven (R-N.D.), chairman of the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, today chaired a hearing to review the FY2018 budget request for the Food and Drug Administration (FDA).

FDA Commissioner Scott Gottlieb, M.D., testified on behalf of the administration’s budget proposals.

In addition to focusing on the budget request, Hoeven recommended that the FDA take action to address overregulation and “the trappings of ‘one-size-fits-all’ solutions.”

“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 North Dakota, their overwhelming concern is that often, overly burdensome regulations coming out of Washington, D.C., can stifle innovation and hinder their ability to create jobs.  While we all support FDA’s mission, we must also be mindful of these concerns,” Hoeven said.

“I believe that the FDA must avoid the trappings of ‘one-size-fits-all’ solutions, and I urge you and your staff to take a commonsense approach,” he said.

The following is Hoeven’s opening statement, as prepared for delivery:

This hearing will come to order.  Good morning.  Today’s hearing will focus on the Food and Drug Administration’s fiscal year 2018 budget request, and thank you Commissioner Gottlieb for being here today to discuss FDA’s priorities for the upcoming year.  Dr. Gottlieb, congratulations on your confirmation, and I want to welcome you to your first appearance before the subcommittee as FDA Commissioner.

Thank you for your public service and your commitment 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.

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 North Dakota, their overwhelming concern is that often, overly burdensome regulations coming out of Washington, D.C., can stifle innovation and hinder their ability to create jobs.  While we all support FDA’s mission, we must also be mindful of these concerns.

I believe that the FDA must avoid the trappings of “one-size-fits-all” solutions, and I urge you and your staff to take a commonsense approach.

In regards to the budget request itself, I am concerned that this request relies on a significant increase in user fees that is not feasible and unlikely to gain congressional approval.  I am concerned that the proposed cuts to budget authority may negatively impact food safety programs and slow the agency’s important work on drugs and medical devices.

That being said, Dr. Gottlieb, I recognize that these decisions were made before you were confirmed, so I hope that you will pledge to work with Congress to ensure that FDA has the resources necessary to meet its critical mission.

We have many other issues to cover this morning, so I will turn it over to Senator Merkley for his opening remarks.

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