UPDATED: Government Shutdown Continues as Gottlieb Clarifies FDA's Activities

Regulatory NewsRegulatory News | 02 January 2019 |  By 

Editor's note: This article has been updated to reflect additional details on FDA activities during the shutdown.

As the partial US government shutdown continues into its thirteenth day, the US Food and Drug Administration (FDA) is clarifying what operations it can carry out while its funding has lapsed.

The partial shutdown began on 22 December 2018 after President Donald Trump refused to sign a stopgap funding bill to keep the government open through the holidays and into early 2019 over funding for a border wall along the southern border.

Since then, neither side has come close to a compromise to end the shutdown and fund the government, leaving roughly a quarter of the government impacted and some 800,000 federal workers either furloughed or working without pay.

During a press conference on Wednesday Trump continued to press for $5.6 billion in funding for border security as a condition for signing a funding bill and said that the shutdown could last "a long time."

On Thursday, Nancy Pelosi (D-CA) took over as Speaker of the House and has said that House Democrats will quickly pass legislation to end the shutdown, though the Senate is poised to reject any legislation that does not have Trump's support.

Impact on FDA

With its funding lapsed, FDA says it can still maintain essential public health-related operations as well as continue to perform user fee funded activities for prescription and generic drugs, biosimilars, medical devices, animal drugs and tobacco products.

"During the lapse period, the agency will be continuing vital activities, to the extent permitted by law, that are crucial to ensuring public health and safety in the United States," FDA says.

However, FDA is only able to perform user fee-funded activities using carry over user fee balances and is unable to accept new user fees assessed in the current fiscal year until new appropriations or a Continuing Resolution is passed.

"Many asked if FDA can accept new medical product applications during the shutdown. The FDA can't collect FY2019 user fee payments during the shutdown, which means we can't accept new applications for products under user fee programs," FDA Commissioner Scott Gottlieb tweeted on Friday.

"For drug and device makers that had planned to submit applications at the start of the year, the shutdown could lead to delays in FDA decision-making."

On Wednesday evening, Gottlieb took to Twitter again to further clarify what activities the agency is able to carry out during the shutdown.

Gottlieb added Wednesday that FDA is still able use carry over funding to hold preapproval discussions with sponsors and accept submissions for which no fee is required such as investigational new drug (IND) applications and supplements to new drug applications (NDAs) and biologics license applications (BLAs) that qualify for fee exemptions.

Additionally, Gottlieb said that 30-day review clock for any non-emergency IND submitted during the shutdown will not begin until a funding measure is enacted.

Gottlieb said that the agency will continue advancing policy work in certain areas, such as developing guidance, though he noted that the funding lapse will prevent the agency from working on other guidances.

Gottlieb clarified that FDA will be able to process certain submissions for generic drugs using carry over user fees, such as changes being effected (CBE) and prior approval supplements, amendments, annual reports and applications for positron emission tomography (PET) drugs. He also said that the agency can accept drug master files (DMFs) to be referenced in generic drug applications, but that the agency won't be able to conduct initial completeness assessments on Type II active pharmaceutical ingredient (API) DMFs if the user fee has not been paid.

Both the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) will also stop performing certain non-user fee funded activities during the shutdown. These include work on over-the-counter (OTC) monograph activities and non-emergency work on whole blood, blood components for transfusion, allergenic extracts and human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated solely under Section 361 of the Public Health Service Act.

FDA will also be able to continue activities with carry over balances from other legislation, such as the 21st Century Cures Act of 2016 and the recently enacted Support for Patients and Communities Act.


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