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The FDA Approval Process Suffers Slowdown Due to Government Shutdown

On October 1, 2013 the Congress of the United States failed to pass a budget or continuing resolution to fund the government’s ongoing routine operations. As a result, the government furloughed 800,000 employees and stopped or curtailed most government programs.

As a result, many unanticipated federal activities ceased or are cut back. For instance, the Food and Drug Administration (FDA) has stopped all food inspections. Other FDA activities have also been temporarily stopped or curtailed.

According to the FDA, the effects of the shutdown are far reaching. Following are the major effects of the shutdown:.

FDA Operations during Shutdown

  1. Emergency work involving the safety of human life or the protection of property;

  2. Criminal law enforcement work; and

  3. 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), 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).

For a long time the FDA has charged for drugs and medical devices to go through its approval process. It appears that until the government restores full services by ending the shutdown no new applications will be accepted for review. This means that the longer the shutdown lasts the larger and longer the backlog for approvals becomes. However, for drugs and medical devices already in the approval process that have paid their process fees, they will continue along the approval process as planned.

Sadly, this also affects people looking forward to joining new clinical trials – it is unclear if new clinical trials can start during the shutdown.

The FDA will not be able to accept applications for review of products scheduled for submission in 2014 for which a fee is required until the government funding for 2014 has been resolved.

The House of Representatives who forced the shutdown has attempted to make exemptions for select activities of the government. However, there have been no attempts to restore funding to the FDA.