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Budget

July 06, 2016 | Daily News

The House Appropriations Labor-HHS subcommittee on Thursday (July 7) will consider a $161.6 billion draft appropriations bill that includes $73.2 billion for HHS but cuts prior-year mandatory funds for the Affordable Care Act and freezes new discretionary spending used to run the law.

June 27, 2016 | Daily News

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.

June 16, 2016 | Daily News

Beneficiary advocates are upset by the Senate appropriators' move to eliminate Medicare State Health Insurance Assistance Program funding in the fiscal 2017 HHS spending bill they passed June 9, and one advocate is urging the House not to follow suit.

June 07, 2016 | Daily News

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.

June 07, 2016 | Daily News

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.

June 07, 2016 | Daily News

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.”

June 07, 2016 | Daily News

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.

May 27, 2016 | Daily News

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.

May 27, 2016 | Daily News

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.

May 17, 2016 | Daily News

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.

May 16, 2016 | Daily News

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.

April 22, 2016 | Daily News

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.

April 21, 2016 | Daily News

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.

April 19, 2016 | Daily News

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.

April 19, 2016 | Daily News

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.

April 18, 2016 | Daily News

House appropriators say in nonbinding report language that FDA should base any guidance to manufacturers on sodium levels in food on an upcoming revision to Dietary Reference Intake (DRI) values being worked on by the Centers for Disease Control and Prevention and the Institute of Medicine (IOM).

April 18, 2016 | Daily News

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.

April 14, 2016 | Daily News

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 report language cleared by the House agriculture appropriations subcommittee Wednesday (April 13), a House Energy and Commerce Committee staffer confirmed for Inside Health Policy.

April 14, 2016 | Daily News

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.

April 13, 2016 | Daily News

The House agriculture appropriations subcommittee cleared a funding bill Wednesday (April 13) with report language that would delay FDA’s controversial guidance bringing laboratory developed tests under the agency’s medical device paradigm, according to Rep. Rosa DeLauro (D-CT), who said she was upset to see such language in the bill.

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