Agency Activity During Government Shutdown

As the government shutdown continues, administrative agencies have been updating the public on their operating status.

The FDA has released a statement on its website explaining that its operations will “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.”  However, while activities funded by carryover user fee balances will continue, the FDA states that it is not able to accept any regulatory submissions for FY 2019 that require a fee payment during the shutdown period—including new medical product applications.  Commissioner Gottlieb has posted regular updates about the shutdown on Twitter, including an update earlier today that was specific to the biosimilars program:

The United States Patent and Trademark Office (“USPTO”) is also maintaining a webpage about its operating status during the government shutdown.  It has issued a statement indicating that it remains open for business as normal.  According to the USPTO, it will continue normal operations “for a few weeks” until it exhausts funds from prior-year collections.  Once the those funds are exhausted, the USPTO “would have to shut down at that time, although a small staff would continue to work to receive new applications and any other examination, post-examination, post-issuance, and PTAB or TTAB filings; receive payments related to such filings; and maintain IT infrastructure, among other functions.”

Stay tuned to Big Molecule Watch for further updates.