Senate Panel Gives Blessing to FDA Appropriations Bill

The Senate Appropriations Committee has voted 28-2 to pass a bill that would grant the FDA $4.6 billion in total funding, an increase of $116 million over FY 2015.

Among the provisions is $134.5 million in medical device user fees, the same as provided for in the House version. It also provides for $424.6 million in appropriations — slightly more than what is included in the House version.

The $148.3 billion measure provides the agency with $2.6 billion in discretionary funds, $107 million less than what was sought in the President Barack Obama’s budget request. The funding numbers are in line with what the House Appropriations Committee agreed to July 8.

The bill also includes a $3 million increase to combat antibiotic resistance — $12 million less than the budget request — as well as a $2 million increase for the Precision Medicine Initiative, which was $8 million less than requested.

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

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.”

She highlighted the efforts of Sens. Jerry Moran (R-Kan.) and Jeff Merkley (D-Ore.), saying in a prepared statement that they “have done a good job with the spartan, sequester-based allocation. But the bill is $1.1 billion short of the president’s request and $65 million below the fiscal year 2015 funding level.”

In her statement, Mikulski stressed that the FDA needs more funding to remain “the gold standard for drug, medical device and food safety.” Merkley agreed, and while he praised the committee’s work, noting that “tough choices were necessary,” he said 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. It failed in 14-16 in a vote that followed party lines.

The bill will now go on to the full Senate for consideration. The House version, H.R. 3049, was introduced in that chamber July 14. The bill, S. 1800, is available at www.fdanews.com/072015-senate-appropriations.pdf. — Elizabeth Hollis