FDA Big Winner in Final Congressional Budget Agreement

After much uncertainty and delay, FDA came away with the largest boost in its annual budget in a decade as part of the final spending package approved by Congress last week. President Trump indicated he would sign the measure in time to avert another devastating federal government shutdown. The funding package for the Department of Agriculture, which includes appropriated funds for FDA, gives the agency $3.068 billion in discretionary funding for fiscal year 2019, a $269-million increase and nearly 9% over last year’s level, noted Steven Grossman of the Alliance for a Stronger FDA.

With some $2.5 billion in approved user fees added in, FDA’s total funding level will be $5.67 billion. While the agency did not gain all the increases requested for certain programs and activities, the result produced smiles all around. The legislators specified hefty expansion in funding to combat the opioid epidemic, to modernize agency data systems, and to transform digital health. There are added resources for efforts to advance domestic drug production and MedTech manufacturing, including continuous manufacturing systems.

The Center for Drug Evaluation and Research (CDER) gained a huge $535-million budget boost. That includes $43 million to support a “new Platform for Drug Development,” including the Oncology Center for Excellence. The added resources will help create new systems for using real-world evidence to evaluate medical products, to modernize generic drug oversight, and to advance rare disease R&D.

Hefty user fees paid by industry will further support oversight and advances in developing a range of medical products. FDA is slated to collect more than $1 billion in fees for prescription drugs and biologics, $500 million for generic drugs, $205 million for medical devices, and $39 million for biosimilars.

The Congressional report on the FDA budget specifies that the agency will use half of the $47 million earmarked for combatting opioid abuse to create a large data warehouse and perform data analytics to better assess vulnerability points in the population, to anticipate new developments in the crisis, and to support regulatory changes. Congress also raises concern about unauthorized marketing of dietary supplements, instructing FDA to report quickly on enforcement actions against supplement manufacturers and marketers, agency inspections in this area, and the scope of serious adverse event reports. And the legislators want action on regulations for medical gases. More detailed information is available in the report from the House Appropriations Committee and will come from FDA following final signing and publication of the budget documents.