Shutdown possible; Updates on food safety and OTC monographs
Top-Line:
Shutdown possible; FDA’s situation projected
FDA utilizes public contest to generate affordable approaches to food traceability; Webinar September 28
Over-the-Counter Monographs: Suddenly lots of movement
FDA announces “FDA New Era of Smarter Food Safety Summit on E-Commerce” October 19-21
Alliance webinar with FDA Chief Scientist Denise Hinton and NCTR Director William Slikker October 15, 3:00-4:00 PM ET
Shutdown Possible; FDA’s Situation Projected. Initially, we forecast that a government shutdown was unimaginable. A few weeks ago, we revised that to “extremely unlikely, but possible.” As we approach October 1, the Congress is at an impasse on whether CR funding should include an increase or suspension of the ceiling on monies the government can borrow. We still expect that to be resolved before the end of the fiscal year, but the possibility of a shutdown is now real and nearly upon us.
We received several questions from our members, as well as the media, about what happens to FDA in a shutdown. We provided three answers:
It is complicated because FDA’s multiple funding streams are treated differently and the plausible argument that nearly all FDA employees should keep working because that work, if not performed, would undermine the public health and safety of the American people.
We would expect that the bulk, if not all, COVID-19 work would be exempt from furlough because we have a declared national public health emergency in effect.
User fees are extremely important to FDA functioning during a shut-down, but there is no neat correlation between the percentage of the review process at each center paid for by user fees and the percent of work that will continue. Among other variables: in the last shutdown, new fee payments were not accepted so the centers were only able to allocate funds from existing balances.
Probably next Monday or Tuesday, HHS (with guidance from OPM and OMB) will provide directions for a possible FY 22 shutdown. This will update guidance for FY 2021 (HHS for all agencies and FDA specific). Presumably, the FY 22 guidance will also reflect experiences from the 2018 and 2013 shutdowns. This week’s Analysis and Commentary (below) looks at what we know about FDA during a shutdown, based on the 2018 experience.
FDA Utilizes Public Contest to Generate Affordable Approaches to Food Traceability; Webinar Next Week. As reported by Food Safety News, FDA received submissions from 90 teams in response to its “Low- or No-Cost Tech-Enabled Traceability Challenge.” The goal is to help achieve end-to-end traceability – from source to table – throughout the food safety system. This week FDA announced the twelve finalist candidates and scheduled an online seminar for each to present their solutions and take questions. The webinar will be from 11 a.m. to 1 p.m. EDT on Sept. 28.
Over-the-Counter Monographs: Suddenly Lots of Movement. Congress overhauled the laws affecting over-the-counter drugs in March 2020 as part of passage of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. This has now resulted in several major program advances. These are described here in an analysis by Politico’s Agency IQ, in its daily newsletter called FDA Today. This is yet another large area of FDA jurisdiction that gets little public attention but is vital to the public health and safety of the American people.
FDA Announces “FDA New Era of Smarter Food Safety Summit on E-Commerce.” The Food Safety Summit will be October 19-21 and explore approaches to “ensuring the safety of foods ordered online and delivered directly to consumers.'' More information can be found here.
Upcoming Alliance Webinars. We continue to invite FDA leadership to address the Alliance membership and media. We have now scheduled FDA Chief Scientist Denise Hinton and NCTR Director William Slikker for October 15, 3:00-4:00 PM ET. The Office of the Chief Scientist at FDA is responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. The National Center for Toxicology Research (NCTR) conducts scientific research to generate data for FDA decision making and develops and supports innovative tools and approaches that FDA uses to protect and promote individual and public health.
Alliance members and media can register here. Non-members wishing to participate should contact Alliance Executive Director Steven Grossman at: sgrossman@strengthenfda.org.