The Week That Was: Ready, Set, Bird Box Challenge

In case you haven’t heard, it’s the New Year. And over at The Week That Was (TWTW) headquarters we spent the last days of December working on a little project: TWTW 2.0, a new, improved version of the newsletter you know and love.

Don’t worry; you’ll still be hearing from us every week. We’ll be sharing a weekly roundup of our favorite stories along with an in-depth look at a top trend or landscape development. But, it will look a little different. We really hope you like it and welcome your thoughts along the way.

So with that, let’s get into it, 2019-style.

   Yes, the FDA is screening your calls

Two weeks into the partial government shutdown, we’re all starting to feel a little shutdown slump: fatigued by headlines and still somewhat confused as to what a partial shutdown really means. So we did some digging to understand exactly what the shutdown means for those of us in healthcare, particularly as it relates to the FDA.

What is a partial shutdown? At the end of last year, some government agencies were already funded for 2019. But many weren’t, and needed a bill passed to cover funding for about seven weeks (spoiler alert: that didn’t happen). The list of affected departments and agencies is extensive, including Department of Justice, Environmental Protection Agency, Department of Homeland Security and Federal Drug Administration.

Did you say FDA? Yup. Though their doors are still open, only 60% of FDA staffers are still at work and some FDA programs and services have been deemed non-essential. 😐

Will products still be reviewed and approved during the shutdown? It depends on the therapy, its review schedule and if it’s being funded through user fees. Here’s a breakdown of what’s on hold, with a little help from Scott Gottlieb’s Twitter feed: 

• User fee funded drug review. Because the FDA can't collect any user fee payments specifically for fiscal year 2019, they “can't accept new applications for products under user fee programs: PDUFA, GDUFA, BsUFA, MDUFA, ADUFA, AGDUFA.”
• Non-emergency CBER and CDER work. For CBER, this applies to work regulated under sec. 361 (pg. 415) of the Public Health Safety Act (whole blood, blood components for transfusion, allergenic extracts and HCT/Ps). For CDER, this applies to “OTC monograph drug activities.”
• Pending, non-emergency INDs. The 30-day clock for these has essentially been put on pause and will start again when the shutdown is over. New INDs that “relate to the safety of individuals who are participating in clinical trials” are deemed emergency and will still be reviewed.

Essentially, per the Alliance for a Stronger FDA, some portion of the drug review process will be put on hold, but NDAs that are already filed and paid for should still be reviewed though “agency time frames may slip.” Or, put another way by our R&RM colleague and former FDA Associate Commissioner, Peter Pitts, as long as the shutdown lasts, “If you’re dealing with the FDA, take the rest of the day off.”

Can Gottlieb go rogue and ignore the limitations? No. Defying the shutdown and continuing business as usual would be considered a felony under the Anti-Deficiency Act.

Still have questions about how the shutdown might affect your work with the FDA? Drop us a note and we’ll put you in touch Peter Pitts (who is working).  

Who wrote this? This issue was written by TWTW managing-editor and R&RM strategist Dana Davis, who is powered by Starbucks red-eyes. This issue was edited by R&RM practice head Meg Alexander, who managed to get a hotel room in San Francisco and will be on the ground at JPM next week.  Syneos Health Communications' Reputation & Risk Management Practice is a team of healthcare communications consultants, policy-shapers and crisis response specialists. We provide unique solutions to the evolving communications challenges in today’s healthcare industry, using evidence-based approaches to help our clients successfully navigate the most sensitive of situations.  

Got thoughts? Contact Dana  

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  Feeling nostalgic? We get it. Check out old TWTW issues here.

Image credits: Elizabeth Warren by Lorie Shaull from the Noun Project, golden gate bridge by Hea Poh Lin from the Noun Project

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