FDA Commissioner: We May Hit a Record Number of Drug Reviews This Year

MAKARY I can t ░░░░░░░░ any individual product or ░░░░░░░░ decision of the FDA ░░░░░░░░ look the process should ░░░░░░░░ transparent and it s ░░░░░░░░ always perfect Sometimes the ░░░░░░░░ Act in their own ░░░░░░░░ of autonomy and independence ░░░░░░░░ re trying to create ░░░░░░░░ standardization and create a ░░░░░░░░ where we have common ░░░░░░░░ For example sometimes we ░░░░░░░░ require routine animal testing ░░░░░░░░ a drug s already ░░░░░░░░ approved in humans and ░░░░░░░░ in thousands of people ░░░░░░░░ Europe It makes no ░░░░░░░░ whatsoever QUICK Because that ░░░░░░░░ down the process a ░░░░░░░░ MAKARY That slows down ░░░░░░░░ process We want to ░░░░░░░░ up the process streamline ░░░░░░░░ modernize it We re ░░░░░░░░ AI now in our ░░░░░░░░ reviews as an organizing ░░░░░░░░ and these applications are ░░░░░░░░ They re like can ░░░░░░░░ a hundred thousand pages ░░░░░░░░ we re going to ░░░░░░░░ a radical concept called ░░░░░░░░ page limit just like ░░░░░░░░ applicants have And we ░░░░░░░░ to allow drug makers ░░░░░░░░ get more predictability and ░░░░░░░░ KERNEN I think about ░░░░░░░░ way the private sector ░░░░░░░░ things and the way ░░░░░░░░ government does things And ░░░░░░░░ think about DMV or ░░░░░░░░ your pick And I ░░░░░░░░ just wondering does the ░░░░░░░░ need more money Is ░░░░░░░░ always the answer I ░░░░░░░░ public schools Money keeps ░░░░░░░░ in It doesn t ░░░░░░░░ it better How do ░░░░░░░░ privatesectorize the FDA to ░░░░░░░░ more all the things ░░░░░░░░ re talking about Streamline ░░░░░░░░ but without just throwing ░░░░░░░░ at it You know ░░░░░░░░ bureaucracies work They don ░░░░░░░░ MAKARY Yeah And every ░░░░░░░░ there s a problem ░░░░░░░░ government KERNEN More money ░░░░░░░░ the answer is always ░░░░░░░░ same more money more ░░░░░░░░ more people KERNEN But ░░░░░░░░ is criticism that you ░░░░░░░░ t have enough right ░░░░░░░░ MAKARY So there s ░░░░░░░░ going to be that ░░░░░░░░ My job is to ░░░░░░░░ an assessment And look ░░░░░░░░ came in right after ░░░░░░░░ reduction in force and ░░░░░░░░ my job is to ░░░░░░░░ sure that all the ░░░░░░░░ and inspectors and we ░░░░░░░░ about 300 law enforcement ░░░░░░░░ with guns that go ░░░░░░░░ and check out things ░░░░░░░░ vape stores in our ░░░░░░░░ to make sure we ░░░░░░░░ safe we ve got ░░░░░░░░ make sure everyone has ░░░░░░░░ the resources To be ░░░░░░░░ there were no reductions ░░░░░░░░ force or layoffs of ░░░░░░░░ reviewers or of inspectors ░░░░░░░░ the FDA QUICK There ░░░░░░░░ been some who have ░░░░░░░░ voluntarily after the departure ░░░░░░░░ Peter Marks and there ░░░░░░░░ been some pushback from ░░░░░░░░ that says Wait a ░░░░░░░░ these were the people ░░░░░░░░ were helping us streamline ░░░░░░░░ process before Now what ░░░░░░░░ Yeah So look I ░░░░░░░░ the FDA does not ░░░░░░░░ on any one individual ░░░░░░░░ no one person makes ░░░░░░░░ breaks a scientific division ░░░░░░░░ s over 1 000 ░░░░░░░░ in that division I ░░░░░░░░ met with the leadership ░░░░░░░░ team They re phenomenal ░░░░░░░░ re going to be ░░░░░░░░ The FDA is going ░░░░░░░░ meet all of its ░░░░░░░░ for review decisions this ░░░░░░░░ I think that we ░░░░░░░░ going to reduce the ░░░░░░░░ time We may hit ░░░░░░░░ record number of approvals ░░░░░░░░ year And so the ░░░░░░░░ are running on time ░░░░░░░░ FDA is strong and ░░░░░░░░ s going to continue ░░░░░░░░ be strong It s ░░░░░░░░ of the greatest brands ░░░░░░░░ the world So we ░░░░░░░░ a lot to live ░░░░░░░░ to And I you ░░░░░░░░ the pride in the ░░░░░░░░ It doesn t matter ░░░░░░░░ what political party is ░░░░░░░░ power you see a ░░░░░░░░ pride among the scientists ░░░░░░░░