Saturday 19 August 2017

Government Shutdown; Update on Impact on USDA & FDA

The US federal government is shutdown. The impact will be felt by all areas of  FDA and USDA regulated industry.

The FDA will cease all non-emergency services not funded by user fees. During the shutdown, FDA operations will be limited to work that involves the safety of human life,  the protection of property and criminal law enforcement. The FDA is part of the Department of Health and Human Services, which furloughed 52% of its staff because of the shutdown. The FDA is expected to furlough 45 percent of its staff. The Agency will  “cease safety activities such as routine establishment inspections, some compliance and enforcement activities, monitoring of  imports, notification programs (e.g., food contact substances, infant formula), and the majority of the laboratory research necessary to inform public health decision-making,” according to the HHS contingency plan.

Some activities that are funded by carryover user fee balances will continue. Those include:  the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA), Medical Device User Fee Amendments (MDUFA), Animal Drug User Fee Act (ADUFA), Animal Generic Drug User Fee Act (AGDUFA), and Family Smoking Prevention and Tobacco Control Act.  As mandated by the Federal Food, Drug, and Cosmetic Act, carryover user fee balances can only be used to fund the activities for which the fees are authorized. During the shutdown, the FDA will not be able to accept any regulatory submissions for medical devices that require a fee payment.

Expect delays with any CDRH or other FDA review.

A federal response to food recalls and outbreaks would also likely be delayed because of staff furloughs at the U.S. Centers for Disease Control & Prevention (CDC), which works jointly with the FDA during an outbreak. The CDC’s website now states: “Due to the lapse in government funding, only web sites supporting excepted functions will be updated unless otherwise funded. As a result, the information on this website may not be up to date, the transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.”

The shutdown will be a test for industry to self regulate. Given the restrictions on the FDA and CDC outbreak management will rely on firms to track and follow-up on product complaints and adverse event. If there is a serious adverse event or basis to recall a product those activities must still be timely completed. 

USDA Shutdown

This morning, a message on the U.S. Department of Agriculture web site reads: “Due to the lapse in federal government funding, this website is not available. We sincerely regret this inconvenience. After funding has been restored, please allow some time for this website to become available again.” Consumers are at risk from a furloughed USDA. The website is not the only USDA asset down, the hotline has also been closed. If there are any recalls for Salmonella, E. coli, Listeria, etc. on meats, poultry, seafood, and eggs, American consumers will rely on industry to take extraordinary steps to notify and remedy the issue. Other USDA programs closed during the shutdown include food safety education and any label reviews – all have been halted.  As part of essential services, inspection of meat, poultry, and egg products will continue, but 1,200 Food Safety and Inspection Service (FSIS) employees will be furloughed.

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