US FDA Communications Stand Out In Shut Down

Commissioner Gottlieb continues to hit all the right notes in his public communications since taking over FDA. His soothing words during the brief government shutdown are the latest example.

What will the impact of the partial federal government shutdown be on federal health agencies? That is a simple, predictable question following the failure of the Senate to act on a continuing resolution to assure funding of federal operations beyond Jan. 19.

Thankfully, no one needed to worry too much about the answer, since the shutdown ended on Jan. 22. But another deadline is coming up in February, and it is still interesting to see how different agencies tried to address the question – or didn’t try as the case may be.

The differences were clear on the various federal websites for those agencies.

On Jan. 22, HHS’ home page included a banner across the top warning visitors that “as a result of the current Federal government funding situation, the information on this website may not be up to date or acted upon.” It then focused on employee concerns: “Updates regarding government operating status and resumption of normal operations can be found at https://www.opm.gov/.”

The Centers for Disease Control & Prevention website included similar language. The National Institutes of Health website did a bit better, including the same basic disclaimer but adding an important bit of information for a key audience: “The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.”

The Centers for Medicare & Medicaid Services website, however, included no acknowledgment of the shutdown whatsoever. The homepage continued to feature a prominent message headlined “Putting Patients First” – but there was absolutely no information for Medicare or Medicaid beneficiaries who may be wondering if they still have benefits during a shutdown. (The answer is “yes,” by the way.)

The outlier was the FDA website. At the top of the page was new, blocked section headlined “FDA 2018 Shutdown Information,” followed by a brief statement of the agency’s status in the shutdown. (See box.)

FDA 2018 Shutdown Information

The FDA plays a critical public health role. Our work provides Americans with better ways to improve their health and welfare, helps families protect their children, and enables consumers to make safe and healthier choices about the products they use and the foods they feed to their families and animals. All our work is important, but only some of our work is permitted to continue during a lapse in funding. In the absence of either an FY 2018 appropriation or a Continuing Resolution for FDA, beginning on January 20, 2018 and continuing until the date of enactment of an FY 2018 appropriation or Continuing Resolution ("lapse period"), 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.

During the lapse period, the agency will be continuing vital activities that are critical to ensuring public health and safety in the United States, consistent with the law. The mission critical, public health activities that will continue include, among other things: 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 criminal and certain civil investigations when we believe public health is at risk, 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. Importantly, we will also continue to address existing critical public health challenges that the FDA has been working on, including the ongoing IV saline shortage that was exacerbated by the 2017 hurricanes in Puerto Rico. Mission critical surveillance for safety concerns with medical devices and other medical products will also continue.

In addition, the FDA will continue to support activities funded by carryover user fee balances, which allows us to continue to bring new therapeutic options to the patients that need them. However, during the lapse period, the FDA will not have legal authority to accept user fees assessed for FY 2018 until an FY 2018 appropriation for the FDA is enacted. This will mean that the FDA will not be able to accept any regulatory submissions for FY 2018 that require a fee payment and that are submitted during the lapse period.

 

The statement itself simultaneously reaffirmed the critical mission of FDA, provided assurance that vital functions are continuing, included specific references to critical situations like the recovery of medical product manufacturing in Puerto Rico and provided important information to manufacturers (like noting that no new user fee pay applications can be received during the funding lapse.)

It wasn’t a ton of information, but it was far more than any other key agency in HHS provided.

That is in keeping with the way FDA has functioned in the Trump Administration. Commissioner Scott Gottlieb has demonstrated time and again that he places a high value on communication – and he has shown considerably savvy in his outreach to help keep FDA morale and performance steady during what has been a tumultuous year for the federal government.

As he has throughout his tenure at FDA, Gottlieb took to Twitter to amplify his communications about the shutdown, including a series of tweets that provided detailed updates about FDA operations. (Also see "What Trump’s FDA Commissioner Could Teach Trump About Twitter" - Pink Sheet, 23 Aug, 2017.)

But he also made sure to include details from an internal email to staff, which included a simple but profound message: “I recognize the consequences of a government shutdown to FDA employees and their families. To my colleagues: You have my personal commitment that ‪FDA leadership will do our best to mitigate the impacts of the disruptions and any burdens to you and your families,” Gottlieb said.

“I join all of FDA leadership in thanking the dedicated staff at FDA during this challenging time. Key staff are working very hard this weekend to make sure mission critical, public health work will continue. I am proud to be Commissioner of this Agency – now more than ever.”

Those sentiments are important, since loss of morale at FDA is by far the biggest potential threat to the biopharma industry in the context of a shutdown (Also see "US FDA Enters Shutdown Mode: Reviews Will Continue, But Will Morale?" - Pink Sheet, 21 Jan, 2018.)

For that reason alone Gottlieb’s very public statements of support for FDA’s mission and its staff are worth remembering even if the one-day shutdown can be quickly forgotten.

From the editors of the RPM Report

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