Pharma Feels Impact of Government Shutdown as FDA Drug Review Work Slows

As the partial government shutdown enters its 21st day, tying it for the longest U.S. shutdown in history, the impact is becoming more and more realized within the pharmaceutical industry. Most noticeably for pharma and biotech, the partial shutdown has brought a halt to some of the operations of the U.S. Food and Drug Administration (FDA). Approximately 40 percent of FDA employees are not working right now due to the lack of financial funding, which means that many of the operations they oversee are not being addressed. Not only has food inspection seen a significant slow, but drug development is also impacted. Forbes noted that the agency has been using leftover prescription fee funding from the past year to pay for drug reviews. Last year, as BioPharma Dive reported, the fees under the Prescription Drug User Fee Act ranged between $1.5 million to $2.7 million. However, due to the shutdown, the agency is not accepting any new user fees set by the Prescription Drug User Fee Act. With a lack of additional funding, the FDA has suspended reviews of existing Investigational New Drug (IND) and Biologics License Application (BLA) applications not covered by user fees, Forbes noted. Also, any such applications that have been filed by companies during the shutdown will not be reviewed. That is creating a delay in the potential approval of new medications, which not only impacts patients waiting for the new medicines, but also the companies that may see some investor confidence shaken.