Update: The government shutdown remains in effect as of Jan. 2, with congressional leadership meeting with President Donald Trump at the White House Wednesday afternoon. FDA Commissioner Scott Gottlieb said the agency will be issuing additional information on activities being continued during the shutdown.
We’re issuing more guidance today on activities that’ll be continuing during the shutdown because of critical public health need. I recognize the impacts this is having on our workforce and we are taking whatever steps we can to address the personal challenges felt by our people.— Scott Gottlieb, M.D. (@SGottliebFDA) January 2, 2019
- House and Senate lawmakers failed to come to agreement on a plan to fund the government on Saturday, extending a government shutdown until after the Christmas holiday. After coming to a bipartisan deal last week, President Donald Trump refused to sign it without his $5 billion border wall funding.
- With the Agriculture Appropriations bill sitting in limbo, FDA is slated to furlough 7,053 employees, 41% of its federal workforce, according to the HHS Fiscal Year 2019 Contingency Staffing Plan. The effects of the shutdown will not come into full force until employees are scheduled to return Wednesday.
- Under a shutdown, FDA will be unable to maintain its routine regulatory and compliance activities, but user fee funded programs, including the medical device, generic and prescription drug programs, will continue.
In a letter to FDA staff Dec. 20 obtained by MedTech Dive, Commissioner Scott Gottlieb said employees would be receiving a letter informing them of their employment status during the shutdown.
Gottlieb emphasized the work done by FDA has a heavy impact on public health. Notably, jobs deemed essential to public health are exempted from the shutdown, according to HHS' plan.
FDA will still conduct "vital activities to respond to emergencies, manage high-risk recalls, pursue criminal enforcement work and civil investigations related to imminent threats to human health or life, review import entries to determine potential risks to health, and respond to other critical public health issues, as appropriate."
But routine establishment inspections and research activities are among the activities negatively impacted by the shutdown.
In addition, funding Gottlieb and device center chief Jeff Shuren had asked for to stand up the Center of Excellence for Digital Health will be delayed. While the House and Senate appropriations differed in funds committed to the agency, a short-term funding deal will not advance the new funding.
The regulators have argued the new center would advance FDA's Pre-Cert model for digital health, move forward a plan to evaluate third-party certifiers of digital technologies under a pre-certification program, create a new cybersecurity unit.
"I recognize that a shutdown will impose challenges for you and your families, and for the public that we are committed to serve. I deeply regret that we face these challenges at any time – and especially at this time of the year," Gottlieb wrote.