Posted 01 May 2017
By Zachary Brennan
The US House and Senate appropriations committees on Monday released government spending bills through the end of this fiscal year, offering the US Food and Drug Administration (FDA) a boost in discretionary spending and user fee revenues.
In total, the agreement on spending through 30 September 2017 contains $153.4 billion in discretionary and mandatory funding, which is $16.3 billion below President Donald Trump’s FY2017 budget request and $12.5 billion above the FY2016 enacted level.
For FDA, the agreement would provide $2.759 billion in discretionary funding, which is $39 million above the FY2016 enacted level. As for the additional funds, $10.9 million is provided to supplement medical product safety and the Precision Medicine initiatives authorized in the 21st Century Cures Act, $10 million is provided for the FDA to respond to emerging health threats, including Ebola and Zika viruses, $2.5 million will go to foreign high-risk inspections, $11.8 million is for FDA facilities and equipment and an additional $35.6 million is provided to support the implementation of the Food Safety Modernization Act.
And total FDA funding, including user fee revenues, would be $4.655 billion, though the Senate and House committees offer conflicting views on whether that total is an increase or decrease. The Senate committee says the total is "$103 million above FY2016," while the House committee says it's $23.3 million "below fiscal year 2016," noting a decrease to reflect "changes to user fee amounts prior to the reauthorization of user fee program" ahead of the next fiscal year.
In March, Trump called to dramatically increase user fee levels to offset FDA spending cuts elsewhere but those plans did not make it into this agreement. Similarly, Trump's budget plan called to substantially cut funding for the National Institutes of Health (NIH), but this agreement would increase NIH funding by $2 billion.
Of the total funds, FDA’s Center for Drug Evaluation and Research will see $1.33 billion, while $339.6 million will go to the Center for Biologics Evaluation and Research and $427.9 million will be for the Center for Devices and Radiological Health. For the user fees, $754 million will be derived from prescription drug user fees, $323 million will be derived from generic drug user fees, $126 million from the medical device user fee program and $22 million from biosimilar user fees, among others.
The text of the spending bill also stipulates that FDA’s commissioner shall issue final regulations on medical gases not later than 15 July 2017. In November, FDA issued a final rule on current good manufacturing practice (CGMP) and labeling regulations for medical gases after incidents occurred in which gas containers holding gases other than oxygen were erroneously connected to a health facility’s oxygen supply system, leading to serious injuries and deaths.
"The agreement strongly urges the FDA to continue to work with Congress to address the
issues and concems regarding the regulation of Laboratory Developed Tests," a House directive said.
The bill also includes a provision aligned with Sen. Lisa Murkowski’s (R-AK) previous calls to bar FDA from introducing genetically engineered salmon in the US without publishing final labeling guidelines for informing consumers.
And like in previous funding bills, the text notes that none of the funds made available may be used to prevent an individual from importing a prescription drug from Canada that complies with the federal Food, Drug, and Cosmetic Act, as long as it's individuals transporting on their person a personal-use quantity of the prescription drug, not to exceed a 90-day supply.
In addition, a provision in the bill would prohibit FDA from considering or approving any proposals for using human embryos for the purpose of genetic modification.
Agriculture, Rural Development, Food and Drug Administration Appropriations Bill, 2017 Omnibus Agreement Summary
Story updated on 5/2/17 with more details.