Senate Committee OK’s extra $40m to FDA but refuses Obama’s $146m plan
The figure adds $40m to the FDA’s 2015 budget, and includes a $5m increase for medical product safety activities. But it falls short of President Obama’s requested budget by $106m, and most of the increase will go towards food safety and not pharmaceuticals.
Some increases fall below budget requests, including an extra $3m to fight antibiotic resistance (Obama requested $15m) and $2m for the FDA’s Precision Medicine Initiative (versus a requested $10m).
The bill also does not increase funding for implementing the FDA Safety and Innovation Act, a 2012 law by which the agency collects user fees from industry to drug review. Requests for more money to oversee drug compounding facilities are denied.
Combined with revenue from user fees, the proposal brings the agency’s budget a $4.6bn.
Approval, compromise, or shutdown?
Now the budget has been passed by House and Senate Committees, it remains to be voted on by both floors, amid larger political battles over spending levels.
Congress may do a budget deal on total spending levels, which could increase the funding given to the FDA.
Alternatively, it could form an omnibus bill combining some agreed appropriations – with possible budget increases to certain agencies – and “continuing resolutions” to maintain FY15 spending levels in other areas. This could erase the $40m gains in the Senate Committee’s proposal.
A third and most extreme possibility is government shutdown if Congress cannot agree on a budget, as happened in 2013. The deadline, unless the government votes to extend it, is midnight on September 30th.
A shutdown would be the worst outcome for the pharma industry, according to Steven Grossman, Deputy Executive Director of Alliance for A Stronger FDA, which campaigns for greater Congressional funding.
If the government does suspend activity, “FDA would continue to be able to work on [new drug] applications using user fees, but the level of disruption would be [enormous],” he told in-Pharmatechnologist.com.
He added another concern for the pharma industry is the sequestration of money from user fees following across-the-board cuts, which would sink funding lower than FY15 levels.
The Senate Committee’s proposed FDA funding is part of its larger 2016 spending bill, which would give bipartisan support to $148.3bn spending on agricultural, food, and public health programmes. The Food Safety Modernization Act of 2010 has several programme deadlines which must be completed in FY16.
