Congress Votes to End Shutdown, FDA Hopes to Resume Activities

Congress has voted to end the US government shutdown. The passage of the short-term spending package will fund the government through February 8, 2018.

The short-term funding agreement is welcome among agencies such as the FDA, which placed nearly half of its staff on furlough during the 3-day shutdown, and paused all work outside “activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fees.”

Though the government has attained funding to carry on with its activities through the next few weeks, the potential for a second government shutdown—one that could potentially be longer than the first—remains overhead after February 8.

For the FDA, government shutdowns have widespread ramifications that can threaten the health and safety of millions of Americans. In the 2013 shutdown, nearly all of the agency’s food safety inspections ceased, along with most of its lab research aimed at informing public health decisions, as did agency efforts to keep drug labelling accurate and up to date.

Margaret Hamburg, MD, FDA Commissioner during 2013, told STAT that the drug approval process was also impacted by the shutdown: “As you know, [industry-funded] programs could continue, but there were delays, advisory committee meetings had to be canceled, review teams were juggling many more tasks [and therefore] less focused and responsive.”

Current FDA Commissioner Scott Gottlieb, MD, said that the agency was be better equipped in the most recent halt in operations than it was in previous shutdowns, and tweeted that the agency has access to carryover user fee funds that allow the agency to continue to review and approve some types of medical products applications.

However, during a shutdown, the government is less capable of carrying out research, addressing issues like drug and device shortages, and monitoring and responding to disease outbreaks.

In terms of financial impact, during every previous shutdown, Congress has allocated back pay for all furloughed federal employees. Thus, shutdowns don’t save the federal government any money, in fact, the 2013 shutdown reportedly cost the government $24 billion, according to the ratings agency Standard & Poor’s.