The White House in its fiscal 2016 budget proposal asked Congress to appropriate $486 million for CDER, a bump in funding of less than one percent, and $215 million for CBER, an increase of two percent.
Under President Barack Obama’s proposal, user fee revenue for drug reviews would also increase, with drugmaker user fees growing from $798 million to $826 million, while generics fees would increase from $312 million to $320 million. Fees for biosimilars would go from $21 million to $21.5 million.
The Office of Regulatory Affairs is also looking at a modest funding increase of just shy of $200,000, from $1.05 million in FY 2015 to $1.24 million in FY 2016.
The budget numbers are part of an overall FDA budget proposal for fiscal 2016 that would increase agency funding by 9 percent above 2015. In all, Congress is asked to appropriate $2.8 billion for the FDA. In addition, the agency would receive $2.177 billion in overall user fees, setting total spending at $4.9 billion, with most of the increase directed at programs overseeing food and veterinary medicine.
Other funding for drug-related initiatives across the federal budget includes a 6 percent hike in R&D funding, including biomedical research. State-level prescription drug monitoring programs will also be getting a boost, thanks to another $100 million in proposed spending to combat abuse of prescription opioids and heroin.
The budget also once again contains a proposal to reduce from 12 years to 7 the exclusivity granted biologics, which Obama has repeatedly proposed in past budgets. Political observers say they see nothing to indicate Congress will approve it.
Similarly, Obama also proposed granting CMS the ability to negotiate drug prices under Medicare’s Part D prescription drug program, which observers also expect will not be approved.
The FDA’s budget request is at www.fdanews.com/02-02-15-FDABudgetRequest.pdf. — Bryan Koenig