Budget

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.

A Senate Appropriations subcommittee approved an HHS spending plan Tuesday (June 7) that gives the National Institutes of Health a $2 billion bump, increases funds to fight the opioid epidemic, eliminates funding for the Independent Payment Advisory Board and would fund the Affordable Care Act at 2016 levels.

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. Sen. Michael Bennet (D-CO) urges passage of his bill to accelerate approval of antibiotics for a limited population, and the HHS says the discovery is a reason for lawmakers to move forward with increased funding for efforts to combat antibiotic resistance.

The House is expected to take up a bill this week sponsored by Appropriations Chair Hal Rogers (R-KY) that would provide $622.1 million in funding to combat the Zika virus, which falls far short of President Obama's $1.9 billion emergency supplemental request.

FDA Commissioner Robert Califf encouraged stakeholders Tuesday (April 19) to push Congress to give more funding for the agency's device center as it works to create a national device evaluation system (NMDES), in remarks at an Alliance for a Stronger FDA meeting.

The House Appropriations Committee passed an FDA spending bill Tuesday (April 19) that hikes funding for food safety oversight, inserts a handful of provisions from the House-passed 21st Century Cures bill, slates $10 million for FDA to combat Zika and Ebola outbreaks, and prevents FDA from limiting sodium in food until bodies outside the agency write dietary reference intake reports.

FDA rejects congressional appropriator' demand that traditional pharmacies be allowed to compound for office-use purposes, stating in a new draft guidance that generally only outsourcing facilities, which are regulated by the agency, can compound non-patient specific drugs for hospitals, clinicians and health care practitioners.

Three provisions of the House-passed 21st Century Cures Act -- Patient-Focused Drug Development, Priority Review for Breakthrough Devices, and Modern Trial Design and Evidence Development -- have made their way into appropriations language cleared by the House agriculture appropriations subcommittee Wednesday (April 13), a House Energy and Commerce Committee staffer confirmed for Inside Health Policy.

House appropriators are again trying to force FDA to scrap its controversial generic drug labeling plan in favor of an industry-backed alternative.