The Food and Drug Administration (FDA), which is already reeling from the layoffs and leadership changes within the Trump Administration, has warned that the government shutdown is also going to delay or pause a significant amount of work at the agency.
In one of the memos that was released before the shutdown started, the FDA confirmed that it forecasts to retain 86% of its staff, or probably 13,872 employees to be specific. The agency can continue to review the existing applications for products, which include the likes of drugs and medical devices, which happen to be funded by user fees; however, there would be no new drug submissions by the FDA.
In addition to no new drug submissions by the FDA, it is also going to stop numerous regulatory activities that do not address the imminent threats when it comes to the safety of human life. For example, the food safety efforts are going to be reduced during the shutdown, and the agency will not be able to support much of the work that has already been done so as to protect the Americans from unsafe as well as ineffective compounded drugs.
It is well to be noted that a shutdown of a few days or a week most likely will not have a major impact when it comes to Americans or on the health-care sector, but an extended standoff when it comes to Republicans and Democrats on the budget would affect the research funding, health insurance negotiations, and, at the end of the day, the flow of new medical products into the market, opine the analysts.
Although the agency has already stressed the fact that most of its employees are going to stay on the job, the total number of workers happens to be less as compared to its previous emergency plan before Trump took over. That plan had asked for 77% of the staff from the FDA, or 15,223 employees, to get retained during a shutdown.
Rick Weissenstein, who happens to be an analyst at TD Cowen, wrote in a note to clients that these numbers happen to reflect the effect of the significant job cuts within the FDA early in the Trump Administration, with many non-user fee positions that are already getting eliminated. Still, he said that the earlier actions happen to mean that the agency probably will not be significantly impacted now if the President follows through on his threat to go ahead and fire more of the federal workforce due to the shutdown.
The budget impasse happens to come during a year that has already featured loads of uncertainty for the industries that are regulated by the FDA. Moreover, in addition to the layoffs throughout the Health and Human Services Department, there are many key officials who have either resigned or been forced to quit the FDA, therefore thinning the expertise and heightening the scrutiny of the ability of the agency to complete the reviews on time.
Marty Makary, the FDA Commissioner, has said that the trains happen to be running on time when it comes to the agency. However, there have been certain signs pointing to slippage, with major products going ahead and facing extension when it comes to review times and a minimum of one case of a delay due to constraint in resources.
