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Biosimilars Law Blog
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FDA Activities During Government Shutdown

The U.S. Food and Drug Administration staff will continue User Fee supported activities and vital consumer protection activities during the government shutdown.  FDA staff, including review divisions and chief counsel’s office, will continue work on regulatory activities covered by user fees 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.

It appears from the HHS Contingency Plan that because of the user-fee funded activities, FDA drug review will be less interrupted during the shutdown than other FDA work.  FDA will be unable to support the majority of its food safety, nutrition, and cosmetics activities. HHS reports that outside of the user-fee funded work, FDA will only “continue select vital activities including maintaining critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review, and other critical public health issues.”

Specifically with respect to the approval and regulation of drugs approved under 505(b) of the Food, Drug, and Cosmetic Act (FDCA) and biologic products, user fee funded activities are defined under FDCA Section 735(6), which covers all aspects of drug review and approval, including the review itself, issuing action letters, conducting approval related inspections, monitoring certain research, postmarket safety activities, adverse event collection, and enforcement activities.  Section 736(7) describes the resources that are covered under the user fees, which includes staff, facilities, and information management.

However, according to an Agency announcement, FDA will not accept any new applications or supplements that require user fee submissions.  Thus, new drug applications (NDAs) and biologics license applications (BLAs) and supplements to NDAs and BLAs that require a user fee will not be accepted during the government shutdown.

It is less clear whether the Agency will continue work on citizen petitions, even those subject to the 505(q) 150-day deadline for FDA response.