- January 15, 2019
Gottlieb and his colleagues have spent the past few weeks juggling their resources to cope with the furloughing of around two-fifths (2/5) of the FDA’s staff and loss of the ability to receive new user fees. Most recently, senior leaders at the FDA have worked with public health experts to identify additional activities staff will need to perform unpaid if the Agency is to fulfill its responsibility to detect and respond to threats to human health.
The additional activities include the expansion of the FDA’s foreign and domestic inspection program beyond the for-cause assessments triggered by reports of specific problems. Gottlieb has also tasked staff with carrying out surveillance sampling of high-risk drugs.
FDA leaders added the tasks to a list of activities they view as expected, unpaid work that originally focused solely on threats that pose an immediate risk to human life and safety. The expansion was necessitated by the continuation of the shutdown into its fourth week. Some tasks can be ignored relatively safely for a few days but not a few weeks, forcing the FDA to continually reassess its plans.
While the FDA has decided it must expand the breadth of expected, unpaid work, many other tasks with less direct impact on human health are on hold indefinitely. Gottlieb has not sugarcoated the impact of the shutdown on the FDA. “It is not business as usual at FDA. Many key functions aren’t getting done,” Gottlieb wrote in a post on Twitter. “The lapse in funding represents one of the most significant operational challenges in FDA’s recent history.”
Faced with the ongoing shutdown, Gottlieb plans to provide an update on additional activities the FDA intends to continue performing in the coming days. Beyond that, the outlook becomes hazy and potentially perilous for the FDA and the companies it regulates.
The FDA has kept itself ticking in recent weeks in part by allocating money generated from user fees to tasks that directly protect public health. That strategy has a finite life span, though. Speaking last week, Gottlieb said the FDA has around one month of money left from the prescription drug user fees it collects to process approval applications.
REFERENCE: Fierce BioTech; 14 JAN 2019; Nick Paul Taylor