‘Alarming’ 0.5% Budget Boost Slammed by FDA Alliance
“We are alarmed that the proposed budget will require FDA to choose among competing public health priorities, which is counter to the national interest and poorly serves the health and safety of the American people.” So asserted nonpartisan Alliance for a Stronger FDA vice president Troy Zimmerman in a 2/9 statement, on learning that Barack Obama’s last FDA budget requests only a 0.5% ($15 million) increase over last year’s budget to $2.74 billion for FY 2017. The alliance signaled a vigorous coming effort to get Congress to upgrade the proposed increase.
With user fees, the total FDA budget balloons to $5.1 billion, an overall increase of 8% or $358 million compared to the FY 2016 enacted level. The proposal says the increase in funding will allow the agency to continue its core medical product safety activities across FDA programs, including improving patient safety; developing the necessary infrastructure for a safer and more modern drug supply; and, continuing expanded and improved oversight of human drug compounding, the proposal says.
As part of the vice president’s Cancer Moonshot initiative, the budget provides $680 million to NIH to expand clinical trials for health disparity populations, pursue new vaccine technology, and fund otheropportunities in cancer research. “These investments will drive scientific advances that aim to understand the causes of cancer, discover new prevention strategies, improve early detection and diagnosis, and cultivate effective treatments,” the budget says. It also includes $75 million for FDA to develop the regulatory pathways for these new technologies, ensure quality systems for trials, and facilitate the sharing of important data across government, academia, and industry.
Under the president’s Precision Medicine Initiative, the Budget proposes $300 million for NIH, an increase of $107 million above FY 2016, to “support development of a research cohort of a million or more individuals to gather data on the interplay of environmental exposures, physical parameters, and genetic information. Research based on this cohort will lay the foundation for findings for many diseases that can lead to new prevention strategies, novel therapeutics, and medical devices.” The budget will also continue funding for the National Cancer Institute to support research efforts on cancer genomics to understand how cancer tumor DNA can be used to predict the right choice of targeted therapies, how resistance to therapy can occur, and how to test new targeted drug combinations. In support of these efforts, the budget proposes giving FDA $4 million to develop the regulatory pathways for these new medical technologies and the Office of the National Coordinator for Health IT (ONC) $5 million to develop interoperable and secure health data exchange systems.
Additionally, the budget proposes to address infrastructure needs by giving FDA $12 million for building and facilities improvements.
“We are disappointed by the administration’s FY 17 request for FDA,” Alliance for a Stronger FDA president Cynthia Bens told FDA Webview. “The proposed budget fails to acknowledge FDA’s vital role in facilitating the development of safe and innovative medical products. We hope that Congress recognizes that FDA is being asked to do more each year with limited resources. To continue to meet its increasing responsibilities, the agency needs to be provided with additional funding that is not included in the president’s request.”