The expected government shutdown will significantly impact the frequency of <"https://www.yourlawyer.com/practice_areas/food_poisoning">food and <"https://www.yourlawyer.com/practice_areas/defective_drugs">drug inspections, says the U.S. Food and Drug Administration (FDA).
“We will be pretty severely limited. We’re hopeful that a resolution is reached before it comes to that,” the FDA official said, quoted CNN Money. The official did not provide details on how many FDA employees will be furloughed; however, CNN Money explained that the agency operates within the Department of Health and Human Services (HHS), has nine centers and offices, and staffs 13,000.
If the shutdown does take place, the FDA’s Office of Regulatory Affairs—the Office oversees food inspections—will have some inspectors working, but will be operating at reduced capacity, CNN Money explained. Should this occur, FDA food processing facility and drug manufacturing plant inspections will be prioritized based on risk, said CNN Money, which explained that this means routine plant inspections will be pushed aside for inspections of high-risk facilities with histories of significant safety issues.
If an emergency occurs—for instance, a foodborne illness outbreak, the FDA will be allowed to recall furloughed staff, said CNN Money.
Some steps in place will not be affected by the furloughs, such as the FDA’s efforts to monitor food coming in from Japan, and food already “in the market,†for increased radiation, noted CNN Money. But, the FDA will not be permitted to conduct drug and medical device maker facility inspections—mandated when a manufacturer files for a new product application—while the shutdown is in effect.
Other FDA centers—the Center for Biologic Evaluation, Center for Veterinary Medicine, Center for Medical Devices, and Radiological Health—will be operating with reduced staff; however, the Center for Tobacco Products will be operating at full capacity. The Center for Tobacco Products staffs 275 workers and is funded by the tobacco industry.
Food safety has long been criticized in the U.S., which led to passage of the Food Safety law, signed by President Obama in January. Geared to prevent foodborne illness, the law enables the FDA to implement recalls and ease how it traces contaminated food back to its origin. Critics have said that the law does not enable sufficient oversight of imported foods and U.S. facility inspections, a situation that will only worsen in the face of a shutdown. Foodborne pathogenic outbreaks have crippled small growers, sickened scores of consumers, and have led to increasing numbers of fatalities and long-term illnesses.
Many critics of the FDA had long complained of safety problems, corruption, conflicts of interest, and budgeting and system problems that appeared to be routine at the agency under the former administration. With the Obama administration, new leaders were put in place and safety became an issue of importance at the FDA. Still, the FDA has made headlines for problems such as inadequate foreign drug manufacturer inspections, uneven drug trials, drug and drug component contamination, and its Medical Device Approval program, known as the 510(k), which quickens U.S. approval of some medical devices. With drug, medical device, and food recalls being reported daily, concerns are mounting regarding consumer safety from defective and deadly products that require increased regulation, but will be seeing decreased oversight if a government shutdown occurs.
