Shutdown Halts FDA Submissions and New Clinical Trials

“Due to a lapse in funding, the U.S. federal government has shut down.”

That’s the message people get when trying to get updated information from the FDA and the Department of Health and Human Services (HHS).

While Medicare will continue to pay hospitals and physicians, device manufacturers and patients relying on new devices and therapies will not see progress from the FDA during the shutdown.

New Clinical Trials Postponed

According to an ABC News blog, a shutdown will mean that NIH (National Institutes of Health) will not be able to accept new patients into clinical trials nor will new trials be able to begin. Per another posting, this means 640 trials will not be accepting new patients.

Submissions Halted

The agency has furloughed 6, 620 employees and until operations resume, will NOT collect any 2014 user fees and will NOT be able to accept any new regulatory submissions that require a fee payment.

According to an October 1, 2013 “Industry Notification: Furlough” posting on the agency’s website:

“In the absence of either an FY 2014 appropriation or a Continuing Resolution for FDA, beginning on October 1 and continuing until the date of enactment of an FY 2014 appropriation or Continuing Resolution (“lapse period”), agency operations will be limited to the following:

• Emergency work involving the safety of human life or the protection of property;
• Criminal law enforcement work; and
• Activities funded by carryover user fee balances, including user fee balances under 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. Carryover user fee balances will only be spent on activities for which the fees are authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

“With respect to medical product user fees, during the lapse period, FDA will not have legal authority to accept user fees assessed for FY 2014 until an FY 2014 appropriation for FDA is enacted. This will mean that FDA will not be able to accept any regulatory submissions for FY 2014 that require a fee payment and that are submitted during the lapse period.”

Routine Safety Activities Halted

In an HHS contingency plan for the shutdown, the FDA will be “unable to support the majority of its food safety, nutrition, and cosmetics activities. FDA will also have to 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.”

As information about specific regulatory submissions, cancelled agency meetings, impacts on clinical trials and inspections come available, we will report them to our readers.