Statement from FDA Commissioner Scott Gottlieb on Administration’s request for new FDA funding

The U.S. Food and Drug Administration holds critical responsibilities for ensuring the safety, effectiveness and security of human and animal drugs, biological products and medical devices; as well as ensuring the safety of our nation’s food supply, cosmetics and radiation-emitting products; and regulating tobacco products. Advances in medical science, product manufacturing, nutrition and digital technologies give us new ways to advance our mission to protect and promote public health, delivering more of the benefits of innovation and market competition to patients in a safe and timely manner. These same opportunities give us additional tools to secure our fundamental consumer protection mission.

Leveraging these opportunities requires us to make ongoing investments in regulatory science that can protect patients and consumers, while also reducing uncertainty for innovators through modern, risk-based regulatory standards; spur investments in new industries and technologies that can improve the health of patients and consumers; secure the safety of food products; and promote competition through more affordable generic and biosimilar products, expanding patient access to effective treatments.  

Toward these goals, the FDA’s budget request of $6.1 billion as part of the President’s Fiscal Year (FY) 2020 budget includes a requested increase of more than $643 million compared to the 2019 Annualized Continuing Resolution (CR) (or $419 million compared to the FY 2019 Enacted Budget) to support urgent public health priorities and help support our core consumer protection mission. This includes more than $220 million to continue advancing new initiatives that will promote medical product innovation.

I want to provide some highlights on some of the high priority initiatives that we seek to fund.

Among the goals that we plan to pursue through these resources: These additional funds will help the agency combat the opioid epidemic; advance new steps to support the production of quality compounded drugs; expand the FDA’s capacity to review human food and animal feed ingredients; and continue implementation of the 21st Century Cures Act to advance patient-centered medical innovations.

Funded programs will also improve food safety and provide consumers with greater information about healthy food choices using the most up-to-date science, modernize our oversight of dietary supplements and advance new innovations to improve the safety of the U.S. blood supply.

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