Budget

Despite warnings from the medical device industry that FDA would be slammed by a backlog of medical product applications that piled up during the shutdown, a former FDA advisory told Inside Health Policy the agency’s user fee-funded activities should return to normal operations and workload shortly.

FDA drug center chief Janet Woodcock warned her staff on Monday (Jan. 28) that progress on rules and guidances might be slower than usual as the agency recovers from a month-long partial government shutdown that left 41 percent of its staff furloughed.

Top medical device lobbyists are pitching a legislative proposal that would let FDA accept user fees for new device applications during the partial federal government shutdown. Lobbyists say the proposal would prevent the agency’s device center from running out of funding during the shutdown and allow reviewers to work on a growing backlog of new device submissions.

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.

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

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.

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.

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.

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.