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January 11, 2019 | Daily News

As the partial government shutdown hits its third week, 33 Senate Democrats penned a letter to FDA Commissioner Scott Gottlieb on Friday (Jan. 11) asking the agency chief how his staff has scaled back oversight of food and medical products; how a shutdown could hinder approval of new medical products and what the agency is doing to address the financial hardship of its staff, 41 percent of whom are furloughed.

January 11, 2019 | Daily News

FDA Commissioner Scott Gottlieb took to twitter on Friday (Jan. 11) to assure stakeholders that, despite the three-week-old partial government shutdown, FDA is “continuing to prioritize our device safety work both before AND after medical devices come to market.”

January 11, 2019 | Daily News

As the partial government shutdown nears its third week, FDA is working to restart inspections of domestic high-risk food facilities, though the furloughed workers who perform those inspections will likely go unpaid until the shutdown ends, FDA Commissioner Scott Gottlieb tweeted on Jan. 9

January 09, 2019 | Daily News

FDA Commissioner Scott Gottlieb reiterated over the weekend (Jan. 5 and 6) that the agency will not accept any new abbreviated new drug applications for generic drugs during the government shutdown, and said that funding to review some pending brand-drug and biologic applications will run out in about a month.

January 03, 2019 | Daily News

Over the holidays and the first days of January, FDA Commissioner Scott Gottlieb issued a steady stream of tweets in a bid to answer stakeholders’ questions about which agency activities are on hold during the partial government shutdown, including user fee-related application reviews, certain medical and over-the-counter product reviews, and non-emergency work on certain biologic products.

January 02, 2019 | Daily News

Nearly two weeks into a government shutdown that has left 41 percent of FDA employees furloughed, an agency expert says the shutdown will disrupt FDA’s long-term planning because it will put off settling the question of how much funding the agency will receive from Congress in 2019.

December 21, 2018 | Daily News

HHS released a contingency staffing plan in anticipation of a possible government shutdown that showed, out of FDA’s 17,397 staff members, 41 percent or 7,053 employees would be furloughed.

December 17, 2018 | Daily News

The head of Alliance for a Stronger FDA warned that FDA food safety inspections would be hit particularly hard should a government shutdown occur on Friday (Dec. 21).

September 13, 2018 | Daily News

The Labor/HHS conference bill agreed to late Thursday (Sept. 13) includes $90.3 billion in discretionary program funds for HHS, or $2.3 billion more than in 2018, invests more in medical research than the president's request, devotes nearly $4 billion to mental health and opioid treatment and omits cuts in the House version that would have blocked CMS' ability to administer the ACA.

August 23, 2018 | Daily News

The Senate passed a fiscal 2019 Labor-HHS spending bill late Thursday (Aug. 23) that didn't include two controversial amendments -- one defunding Planned Parenthood and another allowing the Senate to intervene in the Texas v. HHS case should the court rule to eliminate the mandate for coverage of preexisting conditions.

July 12, 2018 | Daily News

The House Appropriations Committee approved 30-22 a fiscal 2019 HHS funding bill, following a marathon 13-hour markup, that includes a provision blocking any new funding for the Affordable Care Act and prohibiting the use of funding for existing navigator programs.

June 26, 2018 | Daily News

Senate Appropriations HHS subcommittee on Tuesday (June 26) unanimously passed the fiscal 2019 funding bill, sending it to the full committee which plans to consider it on Thursday (June 28).

June 15, 2018 | Daily News

The House Appropriations health subcommittee on Friday (June 15) approved by voice vote a fiscal 2019 HHS spending bill that includes several provisions aimed at stopping implementation of the Affordable Care Act, including a prohibition on any new discretionary funding to implement the law.

May 24, 2018 | Daily News

The Senate Appropriations Committee on Thursday (May 24) voted to send to the Senate floor 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.

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.