US FDA Seeks 8% Increase in Budget

The US Food and Drug Administration is requesting a total budget of $5.1 billion as part of the President’s fiscal year (FY) 2017 budget. The request represents an 8% increase over the enacted budget for FY 2016. The overall request includes a net increase of $14.6 million in budget authority and $268.7 million in user fees for initiatives tied to several key areas, including the implementation of the FDA Food Safety Modernization Act (FMSA) and efforts to improve medical product safety and quality. The agency is also seeking $75 million in new mandatory funding to support the National Cancer Moonshot initiative being led by the Vice President.

“The FDA continues to work to obtain the most public health value for the federal dollar as we address expanded regulatory responsibilities and scientific challenges,” said FDA Acting Commissioner Stephen Ostroff, MD. “The agency remains fully committed to meeting the needs and high expectations of the American people regarding the products we regulate, as well as advancing the prevention, screening, diagnosis, and treatment of cancer.”
 

The FY 2017 request covers the period from Oct. 1, 2016, through Sept. 30, 2017. Highlights of the FDA FY 2017 budget include (net increases of):


• Continued Implementation of a New Food Safety System (+$18.4 million in budget authority; +$193.2 million in user fees): The FDA has finalized major rules that implement the core of FSMA, the most sweeping overhaul of the country’s food safety system since the first federal food safety law was passed in 1906. The FY 2017 budget builds on this work by supporting federal and state efforts to establish enforceable safety standards for produce farms. Funding also will enable the FDA to continue progress to hold importers accountable for verifying that imported food meets US safety standards, as well as conduct food safety audits of foreign food facilities.


• Improving the Safety and Quality of Medical Products (+$3.2 million in budget authority; +$38 million in user fees): The FDA’s FY 2017 budget request seeks to improve safety and quality and support innovation across a wide range of regulated medical products that are crucial to the health of Americans and impact nearly every aspect of medical care in the United States. With this request, the FDA will improve medical product safety and availability by: evaluating precision medicine tools to “personalize” the diagnosis and treatment of disease; improving the safety of compounded drugs through sustained or increased inspection and enforcement activities, and policy development; addressing public health safety concerns associated with antimicrobial drug use in animals to better protect antibiotic effectiveness for both human and animal populations; and supporting animal drug and medical device review. These efforts are in concert with other top priorities such as identifying solutions to prevent prescription opioid abuse, speeding the access to safe and effective generic drugs and reducing the number of drug shortages.


• Supporting the National Cancer Moonshot Initiative (+$75 million in mandatory funding): In order to support the dramatic increase in the number, complexity, and effectiveness of cancer diagnostics and therapeutics, the FDA will develop a virtual Oncology Center of Excellence to leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices. This center will expedite the development of novel combination products and support an integrated approach in: evaluating products for the prevention, screening, diagnosis, and treatment of cancer; supporting the continued development of companion diagnostic tests, and the use of combinations of drugs, biologics and devices to treat cancer; and developing and promoting the use of methods created through the science of precision medicine.


• Investing in the FDA’s Infrastructure (+$3 million in building and facilities funding; +$600,000 in other infrastructure-related funding): The FDA’s responsibilities continue to escalate as the agency works to fulfill the mandates of groundbreaking legislation passed in recent years. This expansion of authorities urgently requires that the FDA’s critical infrastructure at its owned locations is properly functioning to enable the agency to carry out its mission and respond to food safety and medical product emergencies.
 

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.