Budget

The Senate failed Tuesday (Sept. 27) to advance a temporary government spending bill introduced by Senate Majority Leader Mitch McConnell (R-KY) that would fund Zika vaccine development and mosquito control, as well as provide resources for the opioid bill signed into law earlier this year.

House Appropriations health subcommittee Republicans on Thursday (July 7) blocked Democrats’ amendments to restore funding that the chamber's HHS-spending bill would eliminate, such as money for Obamacare programs, comparative-effectiveness research and family planning programs.

Six former FDA commissioners over the weekend expressed support for making the FDA an independent agency, citing concerns with accessibility to the president, the affects of micromanagement on the agency and the “political maze” regulatory decisions currently need to navigate that keep FDA from taking important actions.

Senators may offer provisions of the Senate's version of the 21st Century Cures Act to the National Defense Authorization Act and the agriculture appropriations bill, a congressional aide told Inside Health Policy.

Several public health groups urged lawmakers Tuesday (June 7) to include an amendment in the defense spending bill that would establish a new limited population antibacterial drug approval pathway for antibiotics to treat serious or life-threatening infections, saying the recent discovery of E. coli resistant to colistin, an antibiotic of “last resort,” is a “sharp reminder that antibiotic resistance is outpacing antibiotic development.”

Stakeholders point to the detection of bacteria resistant to a last-resort drug as a reason to accelerate government efforts to combat antimicrobial resistance through increased surveillance and development of new antibiotics.

The Senate Appropriations agriculture subcommittee cleared a spending bill Tuesday (May 17) that would provide $2.8 billion in discretionary funding for FDA, including a $40.2 million boost for food safety activities.

House appropriators noted that only 38,370 prescribers of extended-release and long-acting opioids have been trained through FDA's risk evaluation and mitigation strategy since 2012, which is less than half of FDA's prescriber training goal for 2015 and less than 25 percent of the goal for 2016, coming while FDA contemplates extending the REMS program to immediate-release opioids.

The House Appropriations Committee passed an FDA funding bill that includes report language directing the agency to cease work on its controversial laboratory developed test guidance and to work with Congress on a legislative solution.