The U.S. Food and Drug Administration is requesting a budget of $4.9 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2016 budget—a 9% increase over the enacted budget for FY 2015. The overall request includes $147.7 million in budget authority for initiatives tied to several key areas, including the implementation of the FDA Food Safety Modernization Act and the management of critical medical products issues.
The FY 2016 budget request reflects the FDA’s commitment to fulfill the mandates of groundbreaking legislation passed in recent years, which has given the agency increased regulatory responsibilities. The FDA’s scope has also expanded as it regulates an ever-increasing number of food and medical products imported from all over the world.
“This budget accurately reflects the challenges FDA faces in a global regulatory environment, which is becoming increasingly complex and scientifically demanding,” says Commissioner Margaret A. Hamburg, M.D. “As FDA’s mission expands on several fronts—from the regulation of tobacco products to supporting the development of personalized medicine to ushering in a new era of food safety—we must possess the resources to run a modern agency that fosters innovation and ensures the safest possible drug and food supply for the American people.”
Highlights of the FDA FY 2016 budget include:
• Improving the Safety and Quality of Medical Products (+$33.2 million in budget authority): Medical products regulated by the FDA are crucial to the health of Americans and impact nearly every aspect of medical care in the U.S. The FDA’s FY 2016 request seeks to improve safety and quality and support innovation across the entire spectrum of regulated products. Key priorities include the following: combating the growing threat of antibiotic resistance; facilitating the development and appropriate use of reliable molecular and genetic diagnostics—also known as precision medicine tools—to “personalize” the diagnosis and treatment of disease; implementing key requirements of the Food and Drug Administration Safety and Innovation Act; addressing the safety of compounded drugs and medical products; and implementing the Sunscreen Innovation Act.
• Building a More Modern FDA (+$5.0 million in budget authority, plus $24.0 million already included in the prior highlights): Five major pieces of groundbreaking legislation passed since 2009 have greatly increased the FDA’s responsibilities. As the agency’s mandate expands, more scientists, doctors, analysts, and inspectors are needed to fulfill the FDA’s evolving mission. The FDA’s staffing needs must increase by 70% by FY 2016, compared to FY 2008. FDA requires additional funding for rental payments and a feasibility study to update and issue a revised Master Plan for the White Oak campus in order to address its expanded workforce and the facilities needed to accommodate them.
• Implementing a New Food Safety System (+$109.5 million in budget authority): The FDA Food Safety Modernization Act, signed into law by President Obama in 2011, required sweeping changes to the nation’s food safety program to help prevent foodborne illness, resulting in multiple new regulations and a substantial strengthening of the agency’s food inspection capabilities. The FY 2016 budget request will allow the FDA to: implement fundamental requirements for domestic food and feed safety; acquire the technical staffing needed to support the law, including the training of new inspectors; provide the appropriate guidance to industry about the changes the law will bring; strengthen the role of the states in helping to ensure the safety of the country’s food supply; and build and implement a new import safety system.
For more information:
• The FY 2016 President’s Budget Request for FDA
• FDA Considering How to Tailor its Oversight for Next Generation Sequencing
• Key Investments for Implementing the FDA Food Safety Modernization Act (FSMA)
