FDA OPERATIONS IN THE MIDST OF US GOVERNMENT SHUTDOWN.
With the US Government shutdown-showdown continuing into its 3rd week, we took a closer look at the operations of Food and Drug Administration (FDA) during this period.
According to a statement posted on the FDA website, agency operations continue to the extent permitted by law such as activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fee funds from FY 2018.
FDA specifically named the following mission critical, public health activities that the Agency will continue during this lapse in funding period:
Maintaining core functions to handle and respond to emergencies – such as
- Monitoring for and quickly responding to outbreaks related to foodborne illness and the flu,
- Supporting high-risk food and medical product recalls when products endanger consumers and patients,
- Pursuing civil investigations when we believe public health is imminently at risk and
- Pursuing criminal investigations,
- Screening the food and medical products that are imported to the U.S. to protect consumers and patients from harmful products, and
- Addressing other critical public health issues that involve imminent threats to the safety of human life.
Mission critical surveillance for significant safety concerns with medical devices and other medical products will also continue.
As a consulting company that works closely with the FDA reviewers and investigators, we see the most impact with FDA not able to collect the user fees, whether these fees are for an establishment registration or for a new regulatory submission.
FDA explained they do not have the legal authority to accept user fees assessed for FY 2019 until an FY 2019 appropriation or Continuing Resolution for the FDA is enacted. This means the FDA will not be able to accept any regulatory submissions for FY 2019 that require a fee payment and that are submitted during the lapse period. In plain language, no new submissions for the time being.
We have also seen that companies cannot get a Certificate to Foreign Government (CFG) for their exporting. We have seen a slowdown in FDA inspections of medical device companies though this could be attributed to the start of the New Year. We will have to monitor it as this government shutdown progresses.
It is important to note FDA continues to process the submissions received previously. Our consultants confirmed they were able to work with the FDA in the last few weeks to address those submissions that have already been in review since FY 2018.
Another concern is an FDA oversight of food establishments while operating in this no funding mode. Typically, FDA conducts about 160 inspections of food establishments per week. However, during the shutdown, FDA suspended all routine domestic food facility inspections. The foreign food facilities inspections are continuing though.
In the recent Washington Post interview, FDA Commissioner Scott Gottlieb said he was planning to bring back enough inspectors to investigate high-risk facilities, which deal with sensitive foods such as seafood and cheese. FDA investigators typically look for unclean conditions, bug infestations and harmful contaminations. “We are doing what we can to mitigate any risk to consumers through the shutdown,” Gottlieb said.
mdi Consultants will continue to monitor the current situation and will bring you updates if anything changes. If your company has been impacted by the effects of partial FDA shutdown or you want to discuss any other regulatory concerns, please reach out to mdi for assistance by sending an e-mail to firstname.lastname@example.org or use our contact form.