What If FDA Actually Shuts Down?

As “funding lapse” for US FDA continues, agency continues to triage programs to maximize its ability to protect public health and safety. Is that laudable approach actually counterproductive? 

It says something about the recent pattern of partisan disagreements in Washington, D.C. that FDA has developed a relatively robust playbook for how to handle a lapse in appropriations.

The first step is for everyone to report to work and execute an orderly shutdown. Managers write out plans for shutting down each project or operation. Employees who are furloughed are notified and reminded of their obligations to abide by federal ethics laws. Those who are deemed “essential” stay on the job – but without pay.

In the case of FDA, those whose jobs involve user fee funded activities are also kept on the job, at least until available funds collected before the lapse are used up. Everyone who keeps working is reminded of what they can and legally cannot do during the shutdown period.

Under FDA Commissioner Scott Gottlieb, the pace of public communications continues as well – with added Tweets expressing sympathy and appreciation for the staff’s dedication to the mission. (Also see "Drug Safety Announcement Blitz Highlights Gottlieb's PR Savvy As Shutdown Drags On " - Pink Sheet, 9 Jan, 2019.)

For much of the public, at least, things seem fairly normal.

And, inevitably, some of the politicians responsible for the funding lapse say there will be no lasting harm. They often frame those sentiments in terms of the furloughed employees, who do usually get back pay – ignoring the stress and uncertainty of paying bills due now, not when the back pay is available, to say nothing of contract workers who won’t get back pay and are often among those least able to skip a paycheck.

But really, when the President or elected members of Congress think about the lasting harm of the shutdown, they are most likely thinking in terms of their prospects for re-election. The simple truth is that the shutdown happens and continues because so many of those leaders are confident that 18 months from now, voters won’t put much weight on who did or did not shut down the government.

All of which suggests that, as we head into week four of the current funding lapse, maybe FDA (and other federal agencies) need to throw out the playbook. Maybe – to borrow a phrase of our times – FDA should stop treating a shutdown seriously and start treating it literally.

Just stop working.

No inspections. No product reviews. No meetings with industry, patients or other stakeholders. No one to process an emergency IND request. No inspections of packages at the border. No messages of reassurance or warning from the commissioner or agency press officials. No one to answer the phone – and no voicemail explaining why.

It would be seriously disruptive and, yes, potentially catastrophic. And, for that reason, FDA’s staff would probably the least likely group of people to support such an approach.

But if legislators and the President won’t agree the let the government keep working, maybe it is time for federal workers – including the dedicated professionals at FDA – to stop trying to cushion the American people from the consequences of the petty partisan failures of their elected leaders.

From the editors of the RPM Report