In an opinion piece published in Pharmaceutical Online, Catalyst offers insights into the government shutdown and its effect on FDA, innovation and public health. While FDA has weathered past shutdowns, we are now on track to have the long-running shutdown in US history.
Catalyst President Nancy Bradish Myers explores the fine line that Commissioner Gottlieb is walking, as he must identify which tasks the FDA cannot perform, in order to set expectations with regulated industry and others. “At the same time, as a member of the administration leadership team, he is trying to be reassuring that some at the agency are manning their posts, guarding the public health.”
With each passing day, the likelihood of negative consequences for innovation and public health grows. Ms. Myers explores the potential impacts that she is most concerned about, including delayed product approvals, a slowdown in generic approvals — thus affecting costs to patients — and lower workforce moral, at a time when the FDA is attempting to staff up due to expanding responsibilities
She also looks at the unique aspects of the current shutdown, and the ripple effects it could have throughout the year, even after the funding spigot is turned back on.
Noting that “few of the key FDA stakeholders who are closely tied into the agency seem to be sounding any alarm bells,” she ends with a call to action for stakeholders to advocate for an end to the political stalemate and for funding of the agency now.