FDA User Fee-Supported Activities Continue Despite Government Shutdown

Amid legislative shutdown, some drug review operations tied to residual user fees continue, but all nonemergency activities related to biosimilars have been suspended indefinitely.

Amid legislative shutdown, some drug review operations tied to residual user fees continue, but all nonemergency activities related to biosimilars have been suspended indefinitely.

Despite the government shutdown, the FDA will continue work on regulatory activities and drug reviews covered by user fees. This includes initiatives 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.

Notably, according to an article by InsideHealthPolicy.com, the FDA does not have access to biosimilar user fees, and as a result, all progress on biosimilar development has been halted. According to the news outlet, the FDA will suspend the review of any pending biosimilar regulatory submissions during the government shutdown, including investigational new drug applications (INDs) and meeting requests. This is due to uncertainty surrounding access to Biosimilar User Fee Act (BsUFA) carryover funds, said the source. According to an FDA statement released on October 4, 2013, “The 30-day review clock for any pending, non-emergency BsUFA INDs will be suspended during the lapse period. The clock will resume when the lapse period is over.”

According to a Health and Human Services Contingency Plan, the FDA will also “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.”

The agency sent out a release saying that although some drug review work is occurring, it would not be able to accept new applications associated with user fees. Other meetings, such as an Advisory Committee meeting to discuss the Biologic License Application for Merck’s investigational grass allergy immunotherapy tablet, have been postponed until further notice.

Also affected was the FDA’s and National Institute of Health’s participation in various drug and medical conferences. According to a PharmExec blog, many presentations at the Drug Information Association’s (DIA) conference on Clinical Trial Disclosure and at the Regulatory Affairs Professionals Society (RAPS) annual meeting had to be canceled as a result of the shutdown.

In addition, the FDA’s Vaccines, Blood, and Biologics website home page and its main drug website page featured the following message to users: “Due to the government shutdown, information on this website may not be up to date.”