Post by icemandios on Jan 2, 2019 15:01:15 GMT
At the end of a bumper year for approvals, FDA hit by government shutdown
by Ben Adams | Jan 2, 2019 7:40am
FDA Commissioner Scott Gottlieb took to Twitter over the holidays to explain how the shutdown is hitting the regulator. (FDA)
We saw a major milestone in FDA approvals in 2018, but a political deadlock that led to a partial government shutdown before Christmas could take some of the shine off a golden year.
Scott Gottlieb, M.D., FDA commissioner and President Donald Trump’s pick for the job, took to Twitter over the holidays after the shutdown took effect on Dec. 22, showing those FDA staffers still turning up to work.
But he admits the ongoing political disagreements in Washington are hampering some drug review efforts, tweeting on Dec. 29: “Many asked if #FDA can accept new medical product applications during the shutdown. The #FDA can't collect FY 2019 user fee payments during the shutdown, which means we can't accept new applications for products under user fee programs: PDUFA, GDUFA, BsUFA, MDUFA, ADUFA, AGDUFA.”
In a thread, he added: “We have questions re: drug review work that’s not user fee funded and won’t continue during shutdown. CBER will pause non-emergency work on whole blood, blood components for transfusion, allergenic extracts and HCT/Ps regulated solely under sec. 361 of the PHSA.
“2/2: For our Center for Drug Evaluation and Research this also includes pausing all OTC monograph drug activities. Only emergency work related to these products will continue.
“3/4 The 30-day review clock for any pending, non-emergency IND for a medical product that is not covered by a user fee program will be suspended during the lapse period. The clock will resume when the lapse period is over.
“4/4: However, new emergency INDs and IND amendments that relate to the safety of individuals who are participating in clinical trials will continue to be reviewed during the government shutdown, even for products that are not covered by a user fee program.”
According to the Alliance for a Stronger FDA, 59% (10,344) of FDA employees have been retained and 41% (7,053) furloughed during the shutdown.
On the question of how much of the drug and device product review programs will continue during this phase, the group mused: “The last number we saw, perhaps a year or two ago, is that about 30% of the drug review process is paid for by appropriations. Therefore, logically, some part of the drug review process will not continue during a shutdown. The same would be true of devices, except that a larger percentage of the costs are paid from appropriated funds.
“NDAs/BLAs/PMAs have their own product user fee. Companies that have filed and paid the fee can expect FDA to continue the review, even during a shutdown. [W]hile reviews continue, there is a risk that agency time frames may slip. Also, while we can think of no specific examples, it is possible that a product review could require some activity or input unavailable in the absence of appropriated resources. Additional insight can be gleaned from 2013 guidance.
“Based on past shutdown planning, products on which user fees have already been paid (e.g., NDAs) are more likely to be staffed than earlier stage activities. However, we do not know where the precise lines are being drawn and cannot provide assurance than any given activity will be fully continued (or partly continued or not continued) during a shutdown.”
‏The partial shutdown, which has continued into the new year, comes amid a political impasse over funding for the president’s wish for a wall that would run along the US-Mexico border.
With this political logjam, hundreds of thousands of federal employees have been hit, having to either take unpaid leave or not knowing when they will get paid. This includes Internal Revenue Service workers, customs and border staff, National Parks and housing department workers as well as those at FDA.
by Ben Adams | Jan 2, 2019 7:40am
FDA Commissioner Scott Gottlieb took to Twitter over the holidays to explain how the shutdown is hitting the regulator. (FDA)
We saw a major milestone in FDA approvals in 2018, but a political deadlock that led to a partial government shutdown before Christmas could take some of the shine off a golden year.
Scott Gottlieb, M.D., FDA commissioner and President Donald Trump’s pick for the job, took to Twitter over the holidays after the shutdown took effect on Dec. 22, showing those FDA staffers still turning up to work.
But he admits the ongoing political disagreements in Washington are hampering some drug review efforts, tweeting on Dec. 29: “Many asked if #FDA can accept new medical product applications during the shutdown. The #FDA can't collect FY 2019 user fee payments during the shutdown, which means we can't accept new applications for products under user fee programs: PDUFA, GDUFA, BsUFA, MDUFA, ADUFA, AGDUFA.”
In a thread, he added: “We have questions re: drug review work that’s not user fee funded and won’t continue during shutdown. CBER will pause non-emergency work on whole blood, blood components for transfusion, allergenic extracts and HCT/Ps regulated solely under sec. 361 of the PHSA.
“2/2: For our Center for Drug Evaluation and Research this also includes pausing all OTC monograph drug activities. Only emergency work related to these products will continue.
“3/4 The 30-day review clock for any pending, non-emergency IND for a medical product that is not covered by a user fee program will be suspended during the lapse period. The clock will resume when the lapse period is over.
“4/4: However, new emergency INDs and IND amendments that relate to the safety of individuals who are participating in clinical trials will continue to be reviewed during the government shutdown, even for products that are not covered by a user fee program.”
According to the Alliance for a Stronger FDA, 59% (10,344) of FDA employees have been retained and 41% (7,053) furloughed during the shutdown.
On the question of how much of the drug and device product review programs will continue during this phase, the group mused: “The last number we saw, perhaps a year or two ago, is that about 30% of the drug review process is paid for by appropriations. Therefore, logically, some part of the drug review process will not continue during a shutdown. The same would be true of devices, except that a larger percentage of the costs are paid from appropriated funds.
“NDAs/BLAs/PMAs have their own product user fee. Companies that have filed and paid the fee can expect FDA to continue the review, even during a shutdown. [W]hile reviews continue, there is a risk that agency time frames may slip. Also, while we can think of no specific examples, it is possible that a product review could require some activity or input unavailable in the absence of appropriated resources. Additional insight can be gleaned from 2013 guidance.
“Based on past shutdown planning, products on which user fees have already been paid (e.g., NDAs) are more likely to be staffed than earlier stage activities. However, we do not know where the precise lines are being drawn and cannot provide assurance than any given activity will be fully continued (or partly continued or not continued) during a shutdown.”
‏The partial shutdown, which has continued into the new year, comes amid a political impasse over funding for the president’s wish for a wall that would run along the US-Mexico border.
With this political logjam, hundreds of thousands of federal employees have been hit, having to either take unpaid leave or not knowing when they will get paid. This includes Internal Revenue Service workers, customs and border staff, National Parks and housing department workers as well as those at FDA.