US FDA’s Human Drugs Program Suffers In Adjustment Of Agency Priorities
Executive Summary
President Trump's budget request would boost compounding and vaccines by $5m, but human drugs program would lose $4.8m in training funds.
The Human Drugs Program at the US Food and Drug Administration was largely left out of the proposed increases in the fiscal year 2021 budget in what appears to be an adjustment of agency-wide priorities.
The budget request put more focus on other areas, only offering an increase for compounding and vaccine activities within the Human Drugs program. The FDA’s budget request congressional justification also cuts the Human Drugs program’s training budget, leaving only a small net proposed increase. (See table below for a full list of proposed increases and cuts.)
Gone in the FY 2021 request are increases for rare disease drug development, promotion of domestic manufacturing, and increased use of real-world evidence, which totaled $65m in additional funds proposed for the human drugs program in FY 2020.
The budget proposes a $4.5m increase to establish a robust human drug compounding program, which would strengthen its scientific framework, support activities to promote the 503B bulks list, bolster regulatory compliance initiatives and expand policy development. The agency wrote in the justification document that those activities could not be supported with the current base funding.
Also included was establishment of a compounding center of excellence, which was part of the agency’s FY 2019 and FY 2020 budget requests. (Also see "FDA Again Proposes To Advance Outsourcing Sector With Center Of Excellence" - Pink Sheet, 28 Mar, 2019.)
The Human Drugs program also was given a $500,000 boost to modernize flu vaccines, which would go toward “increased review capacity to facilitate the development and availability of medical products.” Overall, $5m was allocated for the initiative: CBER received $2m, the Center for Devices and Radiological Health received $500,000, and FDA Headquarters received $2m.
At the same time, the agency would institute a $4.8m cut to the Human Drugs program’s outreach, training and organizational excellence spending. CDER would see its budget for the center drop $3.7m and field activities decrease $1.1m in the area. However, the agency wrote that CDER and the Office of Regulatory Affairs, which handles field work, “will preserve its most critical public health and safety activities under this reduction,” including offering necessary staff training and development.
Overall, $19.6m in cuts were slated for the outreach, training and organizational excellence budget.
The agency requested an additional $265.3m for FY 2021, although most of the added money came from increases in user fee revenue. More than half of the increase emerged from proposed fees. (See sidebar.)
AI, Device Safety Increases Don’t Include CDER
Much of the increase that was proposed in the medical product safety area was devoted to other centers.
An artificial intelligence and emerging technologies initiative gained $10.2m in the FY 2021 budget request, although it will be split between CDRH, ORA, headquarters and the Center for Food Safety and Applied Nutrition.
The agency intends for some of the funds to use new technology to ease the burden of supply chain tracking and tracing, such as in the event of a recall or food-borne disease outbreak.
FDA officials also are designing a new data strategy to help staff keep up with emerging science and technology. (Also see "US FDA Data Strategy Will Cover Security For Internal Sharing" - Pink Sheet, 8 Jan, 2020.)
The agency gave an $18m increase to transform medical device safety, cybersecurity, review and innovation. Funds would build a knowledge management system and portal for devices that will enable safety monitoring and better use of pre-existing and new data, according to the budget justification. The FY 2020 budget request devoted an additional $55m to the effort.
Generic drugs staffers also are adapting to a similar new software package, called the Knowledge-aided Assessment and Structured Application (KASA) platform, which were partially funded in FY 2019 and FY 2020. (Also see "Generics Modernization Effort At US FDA Receives Full Funding Over Two Years" - Pink Sheet, 18 Dec, 2019.) The system also will be rolled out to new drugs staff. (Also see "PDUFA VII: Will Gene Therapy's Rise Influence Talks?" - Pink Sheet, 4 Feb, 2020.)
In addition, the FDA is facing a cut in its annual 21st Century Cures funding. The money for the FDA’s Innovation Account peaked in at $75m in FY 2020. Per the statute, the total will be cut to $70m in FY 2021 and fall to $50m in FY 2022 and remain there until FY 2025, the final year of the funding agreement, when it increases to $55m. (Also see "US FDA Getting More Money Up Front Under Cures Bill Revisions" - Pink Sheet, 30 Nov, 2016.)
Underfunded Areas Gain Increases
FDA officials also decided to dedicate part of the proposed funding increase to food-borne outbreak response, oversight of innovative food products and better regulation of cannabis derivatives. These issues were described as “key areas where resources have been historically underfunded and for which there are rising public health needs as growing markets outpace increases to agency resources,” according to the budget justification.
The agency allocated an additional $1.2m for food-borne outbreak response capabilities, and proposed a new innovative food products user fee that would generate $26.1m.
Cannabis derivative regulation would receive a $5m increase that would help regulate use of products with cannabidiol (CBD) in dietary supplements and unapproved food and feed additives.
“FDA must support oversight of increasing numbers of marketed FDA-regulated products containing cannabis-derived substances that may put the public at risk,” the agency said in the budget justification. “Additional resources will directly support regulation of cannabis-derived substances and will indirectly increase capacity of FDA’s dietary supplement and food ingredient review programs.”
The funding was allocated to ORA, CFSAN, headquarters, and the Center for Veterinary Medicine.