During the recent government shutdown that had more than 800,000 federal workers either furloughed or working without pay, numerous federal agencies were finding themselves either closed entirely or offering a limited number of services. As a result, many people began to question just what vital services may have been impacted, including the ability of the federal government to adequately protect the safety of the nation’s pharmaceuticals. Thus, the question remaining is has the U.S. Food and Drug Administration been able to enforce drug safety during the shutdown?
According to most experts, the FDA’s ability to continue enforcing drug safety during the government shutdown was minimally impacted during this event. Based on FDA statistics, 59% of the agency’s workers were still on the job during the shutdown, while 41% were furloughed. While this is still a substantial number of workers who were not on the job, a document from the U.S. Health and Human Services Administration revealed that although certain services may have been limited or unavailable during this time, responding to emergencies and continuing to conduct criminal enforcement and civil investigations that were related to imminent threats to human health or life went on each day.
After many inquiries regarding the services offered by the Food and Drug Administration during the shutdown, FDA Commissioner Scott Gottlieb sent out a tweet to clarify the agency’s ability to still perform services that were deemed to be essential to the nation’s safety. In his tweet, Commissioner Gottlieb noted that while some services would be limited or suspended during the shutdown, inspections of drug imports as well as surveillance of drug adverse events would continue with no interruptions.
However, while this has been generally true, there have been some indications that various services have been stymied to some extent by the shutdown. As an example, new drug applications submitted to the FDA while the shutdown persisted would not be reviewed until the situation came to a conclusion, which could put many companies plans on hold indefinitely. However, new drugs as well as generic drugs that were scheduled to come up for review by the Food and Drug Administration were not impacted by the lack of federal funding. In these instances, all reviews of these drugs were paid by user fees, meaning pharmaceutical companies themselves pay for any drug reviews conducted on their behalf by the Food and Drug Administration.
While it was certainly good news to many people to learn that the nation’s pharmaceuticals were still being closely examined and protected by the Food and Drug Administration during the shutdown, one area that has given people much cause for concern has been the safety of the nation’s food supply. According to FDA Commissioner Gottlieb, there has been no change in the frequency of and thoroughness of inspections regarding imported foods. However, the same cannot be said for food that has been produced here in the United States. Due to having more than 150 FDA food inspectors on furlough, it has been difficult for the agency to inspect various categories of food, particularly dairy items, meat, and various types of produce. Due to the potentially serious consequences that could result from failure to inspect these groups of foods, Commissioner Gottlieb stated the agency was looking at ways it could return its 150 food inspectors to their jobs as soon as possible.
While it does appear as if the nation’s drug safety has not been compromised to dangerous levels during the shutdown, many still question just how many problems may ensue later on as a result of these and other services being limited for five weeks.
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