Impact at the FDA from the Government Shutdown

The impact at the FDA from the government shut, as well as the potential impact to the public, has been running relatively below the radar.  Everyone relies on the FDA for safe medicines, food, and animal products.   If the FDA is feeling the effects from shutdown, so could the public.  In the wake of this lingering shutdown, FDA has been forced to begin to assess its options in order to focus resources on key consumer protection functions.  The longer the government shutdown continues, the greater the potential harm to public health.  Here are some points to consider:

Currently,

• FDA cannot accept any new drug, biologic, device, or generic applications that require payment of user fees until the shutdown ends.
• FDA cannot accept any new INDs for review (aside from emergency INDs).
• User fees and carryover funding could run out within weeks.

Potential far-reaching results:

• Delayed approvals of life-saving drugs.
• Delayed generic approvals, affecting costs.
• Lower workforce morale potentially causing a mass talent exodus from the agency.
• FDA’s ability to recruit and retain staff being severely impaired.

To read the complete article, please follow link:  https://bit.ly/2VXLZVP

To read more about our Leadership, please follow link below.

Our Leadership

James F. Lynch PhD, MBA – Regional Personnel Services ©2019