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May 22, 2018 | Daily News

A Senate Appropriations subcommittee on Tuesday (May 22) voted unanimously to send to the full committee a fiscal 2019 FDA funding bill that appears to give the agency $163 million more than its current level but still less than requested by the administration, coming after House appropriators also agreed to hike FDA spending.

April 17, 2018 | Daily News

House Appropriations agriculture subcommittee chair Robert Aderholt (R-AL) called FDA's request for a 13 percent increase in funding over fiscal 2018 levels “the largest and boldest funding request in recent memory and maybe ever” and signaled it might have to be cut back, but Democrats argued the budget lacks enough funding for food safety and opioids.

April 12, 2018 | Daily News

FDA is seeking $70 million to create a Center of Excellence on Digital Health, which would be tasked with crafting a new regulatory approach toward these products, akin to what FDA is already piloting with its software pre-cert program, according to budget material sent to congressional appropriators.

April 09, 2018 | Daily News

Democrats and seniors’ advocates worry an official estimate of annual government deficits topping $1 trillion by 2020 will spur Republicans to cut Medicare and Medicaid.

February 21, 2018 | Daily News

The Department of Justice is arguing that the proposal to fully fund the Affordable Care Act's risk corridor program included in HHS' budget was the result of an accounting error, and the language has been scrubbed from an updated HHS budget dated Feb. 19.

February 15, 2018 | Daily News

HHS Secretary Alex Azar told senators at a hearing Thursday (Feb. 15) that his agency's proposed cuts to federal spending on graduate medical education would add flexibility to GME programs and allow the agency to focus on training doctors in under-served medical specialties and geographic regions.

February 14, 2018 | Daily News

Sen. Marco Rubio (R-FL) and conservative groups have been quick to criticize the Trump administration for putting risk corridor payments in the president’s 2019 budget request.

February 14, 2018 | Daily News

Neither the House Energy & Commerce Committee nor House appropriators have received FDA's formal budget justification, despite the fact that HHS Secretary Alex Azar will testify before E&C about the budget Thursday (Feb. 15).

February 13, 2018 | Daily News

The president’s budget proposes $16 million in user fees to help the Health Resources and Services Administration administer the 340B drug discount program, a proposal one lobbyist said could end up serving as an offset if lawmakers look to make changes to the program.

February 13, 2018 | Daily News

Should the president's budget hike for FDA get ratified, the agency would spend the extra $400 million dollars on: creating Centers of Excellence for compounding and digital health, researching continuous manufacturing, standing up third-party certification of medical device quality, advancing near-real-time evaluation of real-world evidence, expanding the digital health precertification program, conducting natural history studies for rare disease, and creating new internal agency systems for knowledge management and generic drug submission, according to FDA Commissioner Scott Gottlieb.

February 12, 2018 | Daily News

HHS Secretary Alex Azar said the president's 2019 budget request would improve Medicare by pushing the health system to pay for value rather than volume, and it includes proposals such as reworking medical liability and graduate medical education funding, reducing hospitals' uncompensated care and bad debt pay, applying tweaked competitive bidding for durable medical education to all areas of the country and changing both aspects of the new physician pay system.

February 12, 2018 | Daily News

The president's budget request includes drug-price chopping policies that CMS could accomplish administratively, including proposals to let groups of states negotiate prices using closed formularies and to change the reimbursement of doctors who administer drugs.

February 12, 2018 | Daily News

President Donald Trump's 2019 budget proposal would cut $1.4 trillion from Medicaid over 10 years, give states more flexibility to eliminate some benefits, and impose stricter eligibility and documentation requirements on new beneficiaries.

February 12, 2018 | Daily News

The Trump administration, in a reversal of previous GOP priorities, appears to call for legislation that would fully fund the Affordable Care Act's risk corridor program that ended in 2016.

February 12, 2018 | Daily News

The Trump administration's newly released fiscal 2019 budget allocates $10 billion across HHS to address the opioid epidemic, $10 million of which would be dedicated to FDA investment in regulatory science and tools for stemming opioid abuse and misuse.

February 12, 2018 | Daily News

The Trump administration's fiscal 2019 budget allocates $20 million to FDA's Oncology Center of Excellence, a pleasant surprise for Friends of Cancer Research (Friends), the organization that has been involved with OCE from its inception.

February 12, 2018 | Daily News

The White House is taking on what it views as anticompetitive behavior by some generic drug companies that stave off additional generic entrants by being first to file and then “parking” exclusivity by failing to market their product.

February 12, 2018 | Daily News

Advocates for robust funding of FDA were pleased the president's fiscal 2019 budget released Monday (Feb. 12) calls for a 13 percent increase over fiscal 2018 continuing resolution levels.

February 12, 2018 | Daily News

Less than two weeks after the Republican Party announced it was putting an indefinite pause on its efforts to repeal the Affordable Care Act, the White House on Monday (Feb. 12) unveiled a 2019 budget request that lists replacing the health law “as soon as possible,” via a plan similar to the Graham-Cassidy bill, as a top priority.

February 09, 2018 | Daily News

A newly released Council of Economic Advisors report on drug pricing, which is expected to inform HHS' fiscal 2019 budget request, is angering both public health advocates and those favoring sweeping drug pricing reforms, given it suggests FDA can lower drug prices by speeding FDA approvals of brand drugs and making FDA's approval standards easy to comply with, all while making no mention of brand industry-opposed reforms, including those that have been floated by FDA Commissioner Scott Gottlieb, such as cracking down on abuses of FDA-mandated safety programs.