U.S. Capitol

As the U.S. federal government shutdown enters its second week, life sciences decision makers may be uncertain as to how the shutdown affects the Food and Drug Administration and therefore, how it will impact application reviews, FDA inspections, and other compliance-related activities.

As expected, the effect of the shutdown is far-reaching in the industry.  According to the U.S. Department of Health and Human Services (DHHS), approximately 6,560 FDA employees (45 percent of its workforce) deemed “non-essential” are subject to furlough.

During the shutdown, FDA cannot legally accept New Drug Applications (NDAs), Premarket Approval applications (PMAs), and other applications of this type.  Though FDA has stated that reviews funded by user fees already received, such as NDAs and 510k submissions, will continue to be conducted, we believe that these reviews will happen at a slower pace than is typical.  This potential slowdown will continue for a period of time after the shutdown has ended, as FDA receives a flood of applications and begins to triage and process this backlog.

Life sciences companies with open warning letters or operating under Consent Decree have a rare opportunity to pursue aggressive remediation and inspection readiness activities before FDA resumes its full operations.  QPharma is at the ready to assist clients in the pharmaceutical, medical device, and biotech industries with their regulatory compliance and remediation efforts.