FDA, Politics

Government shutdown to end – at least temporarily – as Dems take McConnell at his word

UPDATE: Democratic votes poured in at Monday’s US Senate meeting in favor of ending the government shutdown by advancing a temporary spending bill. The short-term bill will fund the government through February 8, while Congress dukes it out over immigration. After a morning of intense back room discussions, Senate Majority Leader Mitch McConnell promised Senators that he would put a neutral immigration bill on the floor in the coming weeks to satisfy Democrats concerns. The Senate voted 80-18. House vote pending.

The US Congress failed to come to an agreement over the weekend, meaning the FDA — along with the rest of the US government — has officially shut down. The agency is furloughing nearly half its staff and pausing all its work outside “activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fees.”

The FDA says its highest priorities will include monitoring and responding to flu and foodborne illness outbreaks, high-risk food and medical product recalls, screening imported products, and pursuing criminal and civil investigations.

 

 

The agency will also carry on activities funded by user fee balances, which includes approving new drug applications. However, the FDA will not have legal authority to accept new user fees (meaning the agency won’t accept any regulatory submissions that require a fee payment) until a new spending bill is enacted.

Back in 2013 — the last time a government shutdown closed the FDA — the drug approval process was certainly impacted. There were delays, advisory committee meetings were canceled, and review teams were less focused and responsive, STAT reports.

FDA Commissioner Scott Gottlieb said the agency will be better equipped than previous shutdowns. That’s thanks to user fee programs, which have grown significantly since the last shutdown in 2013.

Republicans and Democrats have been stuck in a standoff this weekend after failing to reach an immigration and spending deal agreement on Friday. Sixty votes were needed to advance the House spending bill, but 45 Senate Democrats and five Senate Republicans rejected it due to its lack of legal protections for young immigrants.

Senate Majority Leader Mitch McConnell has since made a counter offer to the Democrats: a short-term spending bill that would keep the government open until February 8 with the promise of immigration negotiations in the interim.

The Senate is set to vote again on the spending bill today (Monday, January 22) at noon.


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