Senate Panel OKs FDA Funding Bill

In a bipartisan 28-2 vote, the Senate Appropriations Committee Thursday approved the fiscal year 2016 appropriations bill to fund the FDA, but at levels far below what President Barack Obama had requested.

The $148.3 billion measure, which also covers USDA programs and agriculture initiatives, provides the agency with $2.6 billion in discretionary funds — $107 million less than proposed by the president. When combined with user fees, total FDA funding would be $4.6 billion, an increase of $116 million over fiscal year 2015.

The Senate’s numbers are in line with those passed by the House Appropriations Committee on July 8. As with the Senate version, the House bill gives the FDA $2.6 billion in discretionary funding. Total funding, including revenue from user fees, is $4.6 billion.

Under the House version, user fees for prescription drugs would increase from $78 million to $826 million, generic drug fees would go from $312 million to $320 million, and biosimilars and biologicals fees would climb from $21 million to $21.5 million. The Senate committee did not provide a breakdown of user fee monies.

The Senate bill also includes $3 million to combat antibiotic resistance and $2 million for the Precision Medicine Initiative — $12 million and $8 million less than requested, respectively.

The White House introduced the PMI initiative earlier this year with the intent of accelerating biomedical discoveries. It is designed to approach disease treatment and prevention by taking individual variability in genes, environment and lifestyle of each person into account.

A Democratic Alternative

While praising the committee’s work and voting in favor of the measure, Sen. Barbara Mikulski (D-Md.), the top Democrat on the committee, said “the bill did fall short.”

“Senators Jerry Moran [R-Kan.] and [Jeff] Merkley [D-Ore.] have done a good job with the spartan, sequester-based allocation,” Mikulski told the committee. “But the bill is $1.1 billion short of the president’s request and $65 million below the fiscal year 2015 funding level.”

During the hearing, Merkley praised the committee’s work, noting that “tough choices were necessary,” but more needed to be done. He offered an amendment that, among other things, would have boosted FDA funding by $103 million. His amendment also included $12 million to combat antibiotic resistance and $8 million for the PMI.  The amendment failed in a 14-16 vote that followed party lines.

Both the House and Senate bills next go to their full chambers for a floor vote. — Elizabeth Hollis