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Budget

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appropriator' demand that traditional pharmacies be allowed to compound for office-use purposes, stating in a new draft guidance that generally only outsourcing facilities, which are regulated by the agency, can compound non-patient specific drugs for hospitals, clinicians and health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

April 13, 2016 | Daily News

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

March 22, 2016 | Daily News

A bill to cap non-economic damages in medical malpractice suits met the same opposition from states'-rights conservatives at a House Judiciary Committee markup on Tuesday (March 22) as it did in 2011 when the GOP tried to pass the bill.

March 09, 2016 | Daily News

Mandatory funding for FDA and the National Institutes of Health continued to hang over the Senate health committee’s efforts to push forward a counterpart to the House-passed 21st Century Cures package, with lawmakers sparring over the issue at their second markup of health innovation bills.

March 03, 2016 | Daily News

Every Democrat on the Senate health committee has signed on to legislation that would provide an additional $5 billion annually for a handful of programs at FDA and the National Institutes of Health for the next 10 years.

March 02, 2016 | Daily News

The newly minted FDA commissioner faced continued criticism of the agency’s past opioid approval decisions at a hearing on its FY 2017 budget request.

February 25, 2016 | Daily News

Rep. Rosa DeLauro (D-CT) raised concerns Thursday that FDA doesn't have enough money to implement the food safety law, noting at an appropriations hearing that the agency has received less than half of what the Congressional Budget Office said would be needed to implement the Food Safety and Modernization Act (FSMA).

February 22, 2016 | Daily News

President Obama is requesting Congress approve around $1.9 billion in emergency supplemental funding for fiscal 2016 for efforts to respond to the Zika virus, including extra resources for HHS to speed research, development and procurement of vaccines, therapeutics, and diagnostics, and funding to bolster Puerto Rico's flailing Medicaid program.

February 11, 2016 | Daily News

The White House laid out as part of its 2017 budget request ways to lower prescription drug costs for state Medicaid programs, coming as the program plays into election-year politics and becomes embroiled in the drug pricing debate.

February 10, 2016 | Daily News

Nursing homes, hospitals and rural health lobbyists are upset with a proposal in the president's fiscal 2017 budget to further decrease Medicare bad debt payments, and some say providers are still struggling to absorb previous bad debt reimbursement cuts.

February 10, 2016 | Daily News

The White House on Tuesday (Feb. 9) touted plans to increase funding for the National Institutes of Health in fiscal 2017, but that bump is contingent upon Congress approving mandatory funding for the agency, a move research advocates worry would not materialize on Capitol Hill.

February 10, 2016 | Daily News

NIH Director Francis Collins raised concerns on Tuesday (Feb. 9) that a push towards funding disease-specific programs would detour the agency from pursuing basic scientific research, a main pillar of the agency's activities.

February 09, 2016 | Daily News

HHS is asking Congress for the authority to spend $535 million on the health insurance marketplaces as part of a $2.1 billion fiscal 2017 budget for the exchanges that aims to bring in $1.6 billion in user fees from insurers.

February 09, 2016 | Daily News

The Part B drug reimbursement demonstration that CMS communicated to Medicare contractors Friday (Feb. 5) isn't part of the president's proposed budget, and the transmittal was accidentally posted, a CMS spokesperson said.

February 09, 2016 | Daily News

The White House fiscal 2017 budget continues the administration's push for Medicaid expansion with an expected proposal to offer three years of full federal funding for newly eligible beneficiaries to states who have not yet expanded, addresses the substance abuse crisis, extends funding for the Children's Health Insurance Program through fiscal 2019, and includes an unexpected proposal to let states and the federal government jointly negotiate to lower the price of Medicaid drugs.

February 09, 2016 | Daily News

The president's 2017 budget proposes a handful of major new CMS policies, including several aimed at reducing drug prices.

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