Gottlieb tweets on how the US government shutdown will impact FDA, generic drug firms

By PharmaCompass

2019-01-10

Impressions: 99 Article

The United States government saw its third partial shutdown of 2018, that began on December 22, 2018, and is now in its third week.

The shutdown resulted from a demand by President Donald Trump for more than US$ 5 billion in federal funds to build a new US-Mexico border wall. The Congress refused to agree to his funding demand. As a result, around 25 percent of the US government remains closed.

The impasse has forced the Food and Drug Administration (FDA) to partially shut down operations. The FDA commissioner Scott Gottlieb resorted to Twitter to clear all doubts pertaining to the shutdown.

“We’ve received questions from reporters and others related to the generic drug review program at #FDA; and what review activities will continue during the shutdown. I want to provide some information related to these inquiries,” Gottlieb said.

According to him, during the lapse period, FDA will not accept generic drug submissions that require payment of a fee (for example, Abbreviated New Drug Applications or ANDAs)

During the shutdown, about 40 percent of the agency’s employees will be furloughed. The majority are either considered “essential” or have their work funded by user fees paid for by the drug and device industry. The FDA will still implement recalls of harmful food and drugs, but they will stop routine inspections of manufacturing plants.

However, the shutdown will have other palpable effects on the agency, such as slowing down the drug approval process and halting some administrative actions.

“FDA will accept generic submissions for which no fee is required, if product is within the scope of the GDUFA program,” Gottlieb tweeted. These submissions include CBE (changes being affected) supplements and prior approval supplements to approved ANDAs, amendments, annual reports, applications for PET drugs etc.

Gottlieb clarified that sponsors who haven’t paid GDUFA facility fees for FY19 shouldn’t remit payment during the lapse period because FDA cannot accept the fees during the partial shutdown. “FDA will accept Drug Master Files, including Type II Active Pharmaceutical Ingredient DMFs, intended to be referenced in generic applications,” he added.

FDA will not conduct initial completeness assessments on Type II API DMFs for which the fee has not been paid and these new DMFs will not be placed on the Available for Reference List.

“Type II API DMF fees should not be submitted during the lapse period because FDA cannot accept the fees. Fees that are due during the lapse period may be paid as soon as the lapse period ends,” he added.

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“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

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