Govt. Shutdown A Threat To Drug & Device Approval Process

Govt. Shutdown A Threat To Drug & Device Approval Process

Introduction

The government shutdown in the U.S. which started on December 22, 2018, has largely affected the drug and medical device approval process due to a shortage of staff at the U.S. Food and Drug Administration (FDA).

Madris Tomes, CEO of Device Events, told due to the shutdown, there is little or no resources to monitor death and serious injury reports coming into the FDA. The FDA receives approximately 65,000 reports per month just for device adverse events. Also, there has been no warning letters posted by the FDA ever since the shutdown started. Those letters are published after the agency determines a manufacturer significantly violated FDA regulations and are crucial in informing the general public and health care centers about the harmful nature of a drug or device. The FDA posted 19 warning letter in November 2018, but only one in December before the shutdown. Though new drug approvals would take a pause, drug companies are proceeding with the clinical trials.

A letter to the FDA by a group of 34 Democratic senators implied that as soon as the shutdown ends, the agency would be flooded with applications for new drug and device approvals. They wrote this would complicate and slow down the approval process more as there will be a degree of urgency in reviewing a large number of applications. The senators asked the FDA Commissioner Scott Gottlieb to respond to about eight questions about how the agency was planning to handle the financial demands of the shutdown while taking care of the safety and oversight.