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| TIME | SPEAKER | TEXT |
|---|---|---|
| 00:00:28 |
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THE MEETING WILL COME TO ORDER. TODAY, WE ARE HAVING A JOINT HEARING OF THE HEALTH SUBCOMMITTEE AND... |
| 00:05:12 |
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THANK YOU, MR. CHAIRMAN. THANK YOU FOR CONVENING THIS HEARING. H ONE AND ONE HAS BEEN DOMINATING THE... |
| 00:11:20 |
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GERMANS TO PACK? |
| 00:11:21 |
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THANK YOU FOR WORKING WITH ME. -- CHAIRMAN STUPAK. |
| 00:11:32 |
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TODAY WE CONTINUE OUR COMMITTEE'S OVERSIGHT OF THE 2009 PANDEMIC H1N1 FLEW BY EXAMINING THE PRODUCTION... |
| 00:16:38 |
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A GENTLEMAN FROM KENTUCKY. MR. WHITFIELD. |
| 00:16:41 |
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THANK YOU VERY MUCH, MR. CHAIRMAN. I SUSPECT EVERY MEMBER OF THIS PANEL HAS RECEIVED MANY PHONE CALLS... |
| 00:17:51 |
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THANK YOU. MR. WAXMAN. |
| 00:17:58 |
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THANK YOU VERY MUCH, MR. CHAIRMAN. I WANT TO THANK YOU FOR HOLDING THIS JOINT SUBCOMMITTEE HEARING... |
| 00:24:15 |
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I WANT TO COMMEND YOU AND THE CHAIRMAN FOR HOLDING THIS HEARING. SINCE THE INITIAL OUTBREAK OF MARCH... |
| 00:29:17 |
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THANK YOU, CHAIRMAN. NEXT IS A GENTLEMAN FROM TEXAS. Ni LIKE SO MANY OTHER MEMBERS OF CONGRESS ON... |
| 00:32:34 |
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THANK YOU, MR. BURGESS. |
| 00:32:40 |
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THANK YOU FOR HOLDING THIS IMPORTANT JOINT HEARING ON H1N1 PREPARED THIS, PRODUCTION, DISTRIBUTION.... |
| 00:35:04 |
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THE GENTLEMAN FROM PENNSYLVANIA, MR. MURPHY. |
| 00:35:13 |
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THANK YOU. AS WE LOOK HOW WE ARE HANDLING THIS LATEST CRISIS, I REFLECT BACK ON A FEW YEARS AGO WHEN... |
| 00:39:25 |
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THANK YOU. THE GENTLEMAN FROM MISSOURI. MR. BLOGUNT. |
| 00:39:39 |
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THANK YOU FOR HOLDING THIS HEARING. THIS IS AN IMPORTANT TOPIC AND ONE WE SHOULD BE CONCERNED ABOUT... |
| 00:42:29 |
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AS THE CENTERS FOR DISEASE CONTROL REPORTED, THIS HAS CLAIMED OVER 4000 LIVES SINCE APRIL OF THIS... |
| 00:44:26 |
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MIND YOU, MR. CHAIRMAN. THANK YOU FOR TAKING YOUR TIME TO PREPARE AND TO COME IN BE IN FRONT OF US.... |
| 00:47:11 |
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IN TERMS OF PREPARING THE PUBLIC, WE HAVE DONE VERY WELL AND I COMMEND THE PANEL . IN TERMS OF DISTRIBUTING... |
| 00:48:45 |
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THE GENTLEMAN FROM GEORGIA. |
| 00:48:51 |
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TODAY, THE SUBCOMMITTEE ON HEALTH AND OVERSIGHT AND INVESTIGATION WILL HAVE AN IMPORTANT OPPORTUNITY... |
| 00:50:50 |
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THANK YOU. THE GENTLEMAN FROM ARKANSAS. |
| 00:50:57 |
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I WOULD LIKE TO THANK THE CHAIRMAN AND RANKING MEMBER FOR HAVING ENERGY AND COMMERCE COMMITTEE HERE... |
| 00:52:54 |
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WE NEED TO DETERMINE HOW MUCH HAS BEEN PRODUCED AND. ON OUR SECOND PANEL, I WOULD LIKE TO WELCOME... |
| 00:54:47 |
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THANK YOU, THE GENTLEMAN FROM WISCONSIN. |
| 00:55:01 |
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I HOPE THAT THEY WILL ADDRESS THIS IN THEIR AREA OF EXPERTISE. CLEARLY A RESPONSE TO A FLU EPIDEMIC... |
| 00:57:10 |
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THANK YOU, THE GENTLEMAN FROM OKLAHOMA. |
| 00:57:29 |
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I AM INTERESTED TO ALL OF THE ADMINISTRATION AND MANUFACTURERS. MANUFACTURERS HAVE DELIVERED 48.5... |
| 00:59:11 |
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THANK YOU. |
| 00:59:15 |
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THANK YOU. THE CDC AND SECRETARY CIVILIANS AND ALL OF YOU HAVE DONE EXCEPTIONALLY WELL IN YOUR PUBLIC... |
| 01:02:02 |
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THANK YOU. A GENTLEMAN FROM ILLINOIS -- WOMGENTLEWOMAN FROM ILLINOIS. |
| 01:02:19 |
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I WANT TO PUT ON THE RECORD THE EFFECTIVE MANNER IN WHICH WE ARE HANDLING THE VACCINE. THE DEPARTMENT... |
| 01:03:59 |
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THANK YOU. THE GENTLEMAN FROM UTAH, MR. MATHESON. |
| 01:04:07 |
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MY STATE IS NOT UNLIKE MY COLLEAGUES. WE HAVE HAD OUR OUTBREAKS IN SCHOOLS AND COMMUNITIES. WE HAVE... |
| 01:05:58 |
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THANK YOU. |
| 01:06:11 |
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THANK YOU, MR. CHAIRMAN, FOR CONDUCTING THIS IMPORTANT HEARING. WE HAVE A COUPLE OF ALLUSIONS TO ... |
| 01:08:08 |
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THANK-YOU. |
| 01:08:17 |
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SO MUCH HAS CHANGED SINCE THIS COMMITTEE HELD ITS FIRST MEETING BACK IN APRIL. AT THIS TIME, THE FLUTE... |
| 01:10:44 |
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THE OVERSIGHT AND INVESTIGATIONS COMMITTEE HAS HAD A NUMBER OF HEARINGS OVER THE YEARS ON FLU PANDEMIC... |
| 01:12:52 |
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NEXT IS THE GENTLE MAN FROM CONNECTICUT. |
| 01:12:58 |
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THANK YOU FOR A MUCH, MR. CHAIRMAN. I APPRECIATE THIS HEARING. I APPRECIATE IT ESPECIALLY AS THE... |
| 01:15:22 |
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THE GENTLEWOMAN FROM THE VIRGIN ISLANDS, MS. CHRISTENSEN. |
| 01:15:49 |
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THE GENTLEWOMAN PASSES. |
| 01:15:52 |
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HER MICROPHONE IS NOT WORKING. |
| 01:15:56 |
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I AM SORRY. |
| 01:15:58 |
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I THINK THE CHAIRS AND RANKING MEMBERS FOR HAVING THIS HEARING. AS A PHYSICIAN AND A PUBLIC HEALTH... |
| 01:17:34 |
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THANK YOU. |
| 01:17:38 |
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I WANT TO THANK THE MEMBERS OF THE PANEL BOTH FOR THE WORK AND FOR BEING HERE TODAY. I PRESENT THE... |
| 01:20:10 |
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I THANK THE CHAIR MAN. MY THANKS TO THE WITNESSES FOR THE PARTICIPATION, THE WORK. |
| 01:20:26 |
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IT HAS BEEN A LONG TIME SINCE THE WORD SMITE HAS BEEN UTTERED IN THIS HEARING. MY THREE CHILDREN ARE... |
| 01:21:42 |
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I DON'T THINK THAT IT'S APPROPRIATE OR FAIR THAT BIG WALL STREET FIRMS BE GIVEN PRIORITY, ACCESS TO... |
| 01:22:57 |
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GENTLEMAN FROM MARYLAND, MR. SARBANES? |
| 01:22:58 |
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THANK YOU, MR. CHAIRMAN. I WILL BE VERY BRIEF. WE'RE LOOKING FORWARD FORWARD TO YOUR TESTIMONY. I... |
| 01:24:48 |
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THANK YOU, MR. SARBANES. MR. RANGEL? |
| 01:24:50 |
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THANK YOU VERY MUCH, MR. CHAIRMAN, AND I.T. WILL BE BRIEF. I AM THE LIGHT OF THAT WE ARE HOLDING THIS... |
| 01:26:50 |
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THANK YOU, MR. INGLE. I BELIEVE WE CONCLUDE OUR OPENING STATEMENTS. SO WE WILL NOW PROCEED TO THE... |
| 01:28:07 |
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NOTHING TO. |
| 01:28:08 |
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DR. LURIE? |
| 01:28:09 |
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NO THANK YOU. |
| 01:28:10 |
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YOU SAID NO? AND DOCTOR GOODMAN? KNOW, OKAY. SO THEN WE WILL STAND, EACH OF YOU SHOULD STAND. WE WILL... |
| 01:29:00 |
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THANK YOU, CHAIRMAN, AND STUPAK, RANKING MEMBER WALDEN AND MEMBERS OF THE SITE TODAY. I AM REALLY... |
| 01:34:59 |
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THANK YOU, DR. SCHUCHAT. DR. LURIE? |
| 01:35:00 |
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THANK YOU. I TOO AM VERY PLEASED TO BE ABLE TO TALK WITH YOU TODAY ABOUT A PANDEMIC RESPONSE. |
| 01:35:05 |
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MAYBE PUT THAT MICROPHONE ON LITTLE CLOSER TO THERE. |
| 01:35:09 |
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IS THAT BETTER? THANK YOU FOR YOUR FORESIGHT AND HELPING TO REBUILD OUR COUNTRY'S VACCINE INFRASTRUCTURE.... |
| 01:41:09 |
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THANK YOU, DOCTOR LAURA. TRANSIXTY WAS CHAIRMAN STUPAK, MEMBERS OF THE SUBCOMMITTEE, I REALLY APPRECIATE... |
| 01:48:31 |
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THANK YOU, DR. GOODMAN. FAQ TO ALL OF YOU. THE WAY WE PERCEIVE AS WE HAVE FIVE MINUTES PERIOD OF QUESTIONS... |
| 01:51:08 |
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THANK YOU. THE CDC ISSUES NATIONAL STANDARDS ABOUT THE POPULATIONS AT GREATEST RISK FOR DISEASE THAT... |
| 01:52:10 |
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YEAH, I THINK THAT ISSUE WAS OF CONCERN TO ALL OF US, DR. FREEDMAN SENT A LETTER OUT TO ALL OF THE... |
| 01:52:31 |
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AND I UNDERSTAND. I'M NOT SUGGESTING THAT ALTHOUGH SOME HAVE, THAT GOLDEN OR OTHERS ARE GETTING IT... |
| 01:53:09 |
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WILL HAVE A MAJOR COMMITMENT TO VULNERABLE POPULATIONS AND TO THE UNDERSERVED, AND TO MAKE SURE THAT... |
| 01:53:23 |
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I DON'T KNOW IF YOU HAVEN'T, BUT I WOULD LIKE TO SEE MAYBE GET BACK TO ME AT SOME POINT TO TALK ABOUT... |
| 01:54:26 |
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LET ME TRY TO CLARIFY HERE. I THINK THE CHRONIC UNDERFUNDING HAS BEEN IN THE VACCINE INFRASTRUCTURE... |
| 01:55:27 |
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AGAIN, I DON'T WANT, I SAID TO WANT TO BE TWO GUYS OF TODAY, BUT SOMETHING LIKE THAT THE CONGRESS... |
| 01:56:00 |
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WE LOOK FORWARD TO WORKING WITH YOU ON THAT. |
| 01:56:02 |
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THANK YOU. THANK YOU. |
| 01:56:08 |
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WE HAVE EIGHT MINUTES LEFT. WE HAVE THREE VOTES. HE SAID HE WOULD LIKE TO GO NEXT BEFORE BREAK, AND... |
| 01:56:18 |
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THANK YOU, MR. CHAIRMAN AND I WOULD JUST BE PRETTY SHORT. I APPRECIATE BARTS FOCUS BECAUSE IN MY OPENING... |
| 01:57:28 |
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WHAT I CAN SAY IS WE'VE ACTUALLY HAD SEVERAL IN PROSIT REVIEWS ALREADY, AND WE ARE COMMITTED TO AFTER... |
| 01:57:37 |
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DR. LURIE? |
| 01:57:38 |
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I WOULD ADD TO THAT AND I WOULD ALSO ADD THAT THERE ARE PROCESSES IN PLACE, NATURAL EMERGENCY USE... |
| 01:57:58 |
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IF SOMETHING HIT THAT WE DON'T KNOW ABOUT AND WE LOOK AT THIS TIME IT, THEN I GUESS WE IDENTIFY IT,... |
| 01:58:12 |
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THERE ARE SEVERAL MITIGATION STEPS. ONE OF THE THINGS WE DID THIS SUMMER IS UPDATE GUIDANCE FOR MITIGATION.... |
| 01:58:41 |
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DR. GOODMAN? |
| 01:58:42 |
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I REALLY APPRECIATE YOUR COMMENTS. WE WANT TO HAVE A VERY AGILE PUBLIC HEALTH ESPECIALLY IN AN EMERGENCY.... |
| 02:00:09 |
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THANK YOU. SO WE HAVE THREE VOTES AND WE'LL COME RIGHT BACK INTO THAT. THE SUBCOMMITTEE IS IN RECESS.... |
| 02:00:26 |
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THE SUBCOMMITTEE WILL RECONVENE. AND OUR NEXT MEMBER IS THE GENTLEWOMAN FROM WISCONSIN, MS. BALDWIN.... |
| 02:01:18 |
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SURE. I THINK MANY COUNTRIES, INCLUDING THE UNITED STATES, IN THE UNITED STATES WE HAVE THE DEFENSE... |
| 02:03:16 |
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I ALSO AM I OPENING STATEMENT TALK A LITTLE BIT ABOUT USING THIS PANDEMIC SEASONAL FLU AS WAS THE... |
| 02:04:08 |
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I THINK IT IS A REALLY GREAT QUESTION. I THINK AGAIN BARDA IS IN RIGHT NOW HERE, THREE OF US, FIVE... |
| 02:07:01 |
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ISN'T MY UNDERSTAND THAT SOME OF THAT TECHNOLOGY ALSO MAY HAVE AN IMPACT ON INCREASING THE EFFECTIVENESS... |
| 02:07:13 |
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RIGHT. AND I THINK WE'RE CONTINUING TO LEARN MORE ABOUT THOSE, BUT I THINK A LOT OF THESE NEW TECHNOLOGIES... |
| 02:07:35 |
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I WOULD JUST ADD ONE THING, WHICH IS THERE IS A LOT OF AMAZING INNOVATION, INCREDIBLY PROMISING TECHNOLOGY.... |
| 02:09:08 |
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THANK YOU. I WANT TO THANK ALL OF YOU FOR YOUR COMMENTS TODAY. AND I KNOW THAT, I KNOW THAT WE DID... |
| 02:09:47 |
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I JUST WONDER THAT MIGHT BE OKAY IF I JUST RESPONDED TO SOMETHING I HEARD IN A COUPLE OF COMMENTS... |
| 02:09:53 |
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OF COURSE. |
| 02:09:54 |
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I WAS CONCERNED THAT WE REALLY HAVEN'T HAD A CHANCE TO I THINK CORRECT SOME MISUNDERSTANDINGS HERE.... |
| 02:10:32 |
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ALL RIGHT. THANK YOU VERY MUCH. DID YOU WANT -- MR. GINGRICH ERA OR COME HE HASN'T HAD A CHANCE TO... |
| 02:10:46 |
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MR. CHAIRMAN, THANK YOU. I AM PLEASED THAT THE FIRST PANEL IS STILL HERE. YOU KNOW, I HAVE SOME CONCERNS,... |
| 02:13:33 |
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THANKS FOR THOSE COMMENTS. COMMUNICATION IS REALLY IMPORTANT TO ALL OF US, AND BE CLEAR AND NOT CONFUSING.... |
| 02:15:11 |
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WITH ALL DUE RESPECT BECAUSE MY TIME IS LIMITED I WANT TO MAKE ONE OF THE POINTER AND I APPRECIATE... |
| 02:16:48 |
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I'M GOING TO LET YOU AND MR. GINGRICH'S QUESTION. AND ALSO, I'VE GOT TO BE CAREFUL HERE, DR. LURIE,... |
| 02:17:10 |
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RESPOND MR. GINGREY. |
| 02:17:13 |
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YOU RAISE ONE OF THE MOST CHALLENGING ASPECTS OF THIS PANDEMIC. AT THE VERY TIME PEOPLE ARE WAITING... |
| 02:18:47 |
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ARE YOU DONE WITH MR. GINGREY'S RESPONSE? OKAY. MR. GREEN, LET ME JUST EXPLAIN WHAT HAPPENED IS IT... |
| 02:19:09 |
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DR. LURIE, YOU HAVE ANYTHING TO DO WITH THE MILITARY AND GETTING THE CONTROL OF THE DRUG TO THE MILITARY,... |
| 02:19:17 |
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NO, THIS WHOLE CONTROL IS RUN BY THE DEPARTMENT OF DEFENSE. |
| 02:19:18 |
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SO YOU DON'T KNOW IF PEOPLE ACT ONE, HAS RECEDED, IF ANYONE AT ONE, HAS A. YOU DON'T KNOW THE 218... |
| 02:19:35 |
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WHAT IS YOUR SOURCE THEN -- |
| 02:19:36 |
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RUN BY THE DEPARTMENT OF DEFENSE AND THEY HAVE PRETTY STRICT CRITERIA JUST LIKE WE DO. GOING TO U.S.... |
| 02:19:47 |
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BUT THE POINT IS -- |
| 02:19:49 |
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I JUST WANT TO SPEAK UNDER ALL OF YOU SAID THEY DID NOT RECEIVE A. YOU DON'T KNOW THAT. WENT MAJOR... |
| 02:20:12 |
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WHAT I WAS TRYING TO DO IS CORRECT A MISCONCEPTION ABOUT HOW THE VACCINE WAS JUST RIVETED. I DO NOT... |
| 02:20:21 |
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RECORD I REALIZED UNIFORM PERSONAL ARBOR REQUIRED FIRST. AND EVEN THESE DETAINEES WILL HAVE A RIGHT... |
| 02:20:41 |
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FAIR ENOUGH. |
| 02:20:42 |
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MR. GREEN. |
| 02:20:44 |
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THANK YOU, MR. CHAIRMAN. I APPRECIATE THE PATIENCE OF OUR WITNESSES. YOU BEEN HERE A LONG TIME. I... |
| 02:22:56 |
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I THINK THERE ARE SEVERAL THINGS WE COULD DO TO STRENGTHEN OUR RESPONSE FOR SEASONAL FLU AS WELL AS... |
| 02:23:30 |
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IN THE PRIVATE HEALTH CARE SYSTEM WITH PUBLIC HEALTH NEEDS. WE COULD DO MUCH BETTER TARGETING OF PRIORITY... |
| 02:23:52 |
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AND I APPRECIATE THAT, AND WE'RE GOING THE RUN OUT OF TIME, BUT WE'RE TALKING ABOUT PEDIATRICIANS.... |
| 02:24:21 |
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A BROADER MANUFACTURING CAPACITY, BUT WITH CHILDREN IF YOU LOOK AT THIS PANDEMIC, IT'S DISPROPORTIONATELY... |
| 02:25:00 |
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CERTAINLY, AND I WOULD REALLY SECOND THE COMMENTS ABOUT REALLY STRENGTHENING THE PUBLIC HEALTH INFRASTRUCTURE... |
| 02:25:55 |
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THE GENERATION THAT DEALT WITH POLIO, I KNOW WE USED THAT GENERATION MANY TIMES AT OUR HEARINGS. ... |
| 02:26:23 |
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THANK YOU. I GUESS I'M GOING TO SAY THANK YOU AGAIN. I WON'T REPEAT WHAT I SAID AGAIN THOUGH. THANK... |
| 02:26:43 |
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THANK YOU. [INAUDIBLE CONVERSATIONS] |
| 02:27:08 |
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WE'VE DONE A LITTLE SWITCHING HERE, AND WE'LL CALL OUR SECOND PANEL UP. THIS INCLUDES MR. PAUL WE ALL... |
| 02:29:06 |
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GOOD AFTERNOON, MEMBERS OF THE COMMITTEE. I'M PRESIDENT OF THE U.S. DISTRIBUTER OF INFLUENZA VACCINES... |
| 02:34:00 |
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THANK YOU. DOCTOR? WOULD YOU LIKE TO TESTIFY? PULL THAT UP AND TURN THAT MIC ON, PLEASE. THANK YOU.... |
| 02:34:06 |
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GOOD AFTERNOON. I WANT TO THANK CHAIRMAN STUPAK, CHAIRMAN PALLONE, RANKING MEMBER WALL DON AND THE... |
| 02:38:30 |
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THANK YOU, DOCTOR. YOUR TESTIMONY, PLEASE. TURN THE GREEN LIGHT ON AND TINT FORWARD. THANK YOU. |
| 02:38:37 |
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CHAIRMAN STUPAK, PALLONE, RANKING MEMBERS, MEMBERS OF THE COMMITTEE, THANK YOU FOR THE OPPORTUNITY... |
| 02:43:16 |
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THANK YOU, DOCTOR. MR. HASBACK, YOUR TESTIMONY, PLEASE. |
| 02:43:21 |
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GOOD AFTERNOON, MR. CHAIRMAN. THANK YOU FOR THE OPPORTUNITY TO TESTIFY BEFORE THE THE SUBCOMMITTEES... |
| 02:48:31 |
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THANK YOU. DR. LEAHY? |
| 02:48:33 |
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CHAIRMAN STUPAK, CHAIRMAN PALLONE AND MEMBERS, RANKING MEMBER WALL DIN, I'M THE COMMISSIONER OF THE... |
| 02:50:25 |
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THESE PLANS RELATED TO THE SEVERITY OF THIS PANDEMIC. WE DECIDED TO USE THE PRIVATE SECTOR, THE LOCAL... |
| 02:55:43 |
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PLEASE SUMMARIZE. |
| 02:55:44 |
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OKAY. I THINK WE ALSO HAVE A CHALLENGE RELATED TO THE PUBLIC HEALTH HAS BEEN FUNDED AND THAT'S BEEN... |
| 02:56:24 |
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THANK YOU, DOCTOR. DR. LEVY? YOUR TESTIMONY. |
| 02:56:28 |
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THANK YOU, CHAIRMAN STUPAK, CHAIRMAN PALLONE, RANKING MEMBER AND MR. GREEN. THANK YOU FOR THIS OPPORTUNITY... |
| 03:01:53 |
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THANK YOU. THANK YOU, ALL, FOR YOUR TESTIMONY. DOCTOR -- HOW DO YOU SAY YOUR LAST NAME? |
| 03:02:04 |
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FAR SIMILAR MONO. |
| 03:02:06 |
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LET ME ASK YOU ABOUT NOVEMBER 3RD, YOU SIGNED THE LETTER BACK TO US, TO THE COMMITTEE, WE ASKED A... |
| 03:03:00 |
|
THAT'S CORRECT. WE HAVE TWO H1N1 VACCINES LICENSED IN EUROPE AND IN OTHER PARTS OF THE WORLD WITH... |
| 03:03:12 |
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OKAY. IS THERE A SAFETY ISSUE WITH -- I THINK THE FDA SAID THEY HAD NOT APPROVED IT, AND IF MY NETWORK... |
| 03:03:28 |
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THE MF59'S NOT APPROVED IN THE U.S., BUT WE'VE LICENSED IT IN EUROPE. WE HAVE A PRETTY BROAD RANGE... |
| 03:03:53 |
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MY 15 YEARS HERE I'VE ALWAYS BONN DRUG COMPANIES. YOU SAY IT'S BEEN LICENSED SINCE '97 IN THE REST... |
| 03:03:59 |
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THAT'S CORRECT. IN THE ELDERLY. WE HAVE IT LICENSED DOWN NOW TO SIX MONTHS OF AGE. OVERSEAS THEY'RE... |
| 03:04:08 |
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OKAY. I THOUGHT I HEARD DR. GOODMAN OF THE LAST PANEL INDICATE THEY'VE ORDERED A STOCKPILE OF THIS... |
| 03:04:19 |
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THAT IS CORRECT. WE'RE MAINTAINING STOCKPILE IN LOUISVILLE, KENTUCKY. |
| 03:04:25 |
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AND I ASKED HIM, THEN, WHEN ARE WE GOING TO USE IT? WHERE -- WHEN DO WE GET TO THE POINT WE'RE GOING... |
| 03:04:35 |
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WE HAD A DISCUSSION WITH THEM IN EARLY MAY AS TO HOW TO PROCEED, AND THE DECISION AT THAT POINT WAS... |
| 03:05:08 |
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OKAY. I THINK IN YOUR TESTIMONY YOU STARTED DISCUSSING THIS 2007 WHETHER YOU SHOULD USE ADDY VENT... |
| 03:05:23 |
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WE APPLIED FOR A NEW DRUG APPLICATION, IND, AN INVESTIGATIONAL NEW DRUG IN 2008, AND WE'VE BEEN GOING... |
| 03:05:36 |
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DO YOU SEE THIS ISSUE, THAT JUST WON'T BE WITH H1N1, BUT REALLY ANY KIND OF A VACCINE, ISN'T IT? ... |
| 03:05:47 |
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THAT'S CORRECT. THERE'S A NUMBER OF BENEFITS. ONE IS YOU IMPROVE THE IMMUNEY IN ADDITIONTY SO IF YOU... |
| 03:06:24 |
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DR. RE VIE, IS IT FAIR TO SAY THIS IS SOMETHING WE OUGHT TO LOOK AT AS A COUNTRY? I KNOW YOU MENTIONED... |
| 03:06:39 |
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OH, IT'S DEFINITELY SOMETHING WE SHOULD LOOK AT CLOSELY, AND I BELIEVE THE FDA IS DOING THIS IN A... |
| 03:07:15 |
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SURE. |
| 03:07:17 |
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TO ADD ON THROUGH AN EMERGENCY USE APPLICATION A NEW ELEMENT THAT MAY, INDEED, BE SAFE COULD WELL... |
| 03:07:30 |
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SO THIS ONE'S BEEN AROUND FOR, AS THEY SAID, I THINK '97 OR SO AND BEEN APPROVED. WOULD IT BE PRUDENT... |
| 03:07:48 |
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IT IS SOMETIMES HARD TO UNDERSTAND WHY THERE IS SO MUCH HESITANCY AROUND VACCINES IN GENERAL. |
| 03:07:54 |
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RIGHT. |
| 03:07:56 |
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AND A PARTICULAR VACCINE. I THINK WE HAD A REAL PUBLIC HEALTH QUESTION AS TO WHETHER PEOPLE WOULD... |
| 03:08:03 |
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RIGHT. |
| 03:08:06 |
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NOW, IF THINGS HAD BEEN WORSE AND THIS HAD BEEN A MUCH MORE SEVERE PANDEMIC, WE MAY HAVE NEEDED TO... |
| 03:08:31 |
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MY TIME'S UP. MR. WALDEN FOR QUESTIONS, PLEASE. |
| 03:08:33 |
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THANK YOU VERY MUCH, MR. CHAIRMAN. FOR THOSE OF US WHO DON'T SPEND OUR LIVES IN THE WORLD YOU'RE IN,... |
| 03:08:46 |
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SURE, THEY'VE BEEN USED IN THE UNITED STATES SINCE THE 1920s, THERE'S ONE CALLED ALUM THAT'S BEEN... |
| 03:08:53 |
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PULL THAT MIC A LITTLE CLOSER. |
| 03:08:56 |
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GEY VENTS ARE ACTUALLY ADDITIVES THAT WE PUT IN THE VACCINE THAT ACTUALLY BOOST THE IMMUNE RESPONSE.... |
| 03:09:16 |
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AND IF YOUR CLINICAL TRIALS OVERSEAS, DID I HEAR YOU SAY CORRECTLY YOU HAVEN'T SEEN ANY ADVERSE RESPONSE... |
| 03:09:27 |
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I ALSO WANTED TO CORRECT, WE HAVE NOW 25,000 SUMMITS THAT ARE NON-ELDERLY, WE HAVE QUITE A ROBUST... |
| 03:09:45 |
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WHEN IN '08 DID YOU APPLY TO FDA FOR APPROVAL? |
| 03:09:48 |
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JUST TO CLARIFY, THE FIRST STEP IS TO FILE AN IND, AND SO WE FILED FOR THE IND WHICH WOULD THEN ALLOW... |
| 03:10:08 |
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RIGHT. AND WHEN IN '08 DID YOU DO THE FIRST -- |
| 03:10:11 |
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I COULD GET BACK TO YOU WITH THE EXACT DATE, I THINK IT WAS MID '08. |
| 03:10:14 |
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AND WHAT ELSE DO YOU HEAR FROM FDA THAT YOU NEED TO SUPPLY THAT YOU HAVEN'T? |
| 03:10:20 |
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I THINK THEY, THEY WOULD LIKE TO SEE ADEQUATELY CONTROLLED, RANDOMIZED STUDIES UNDER FDA OVERSIGHT... |
| 03:10:52 |
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OKAY. SO GOING BACK THEN, WELL, LET ME RUN THIS ON OUT. I MEAN, IF THIS WERE THE FEARED AVIAN FLU... |
| 03:11:29 |
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I MEAN, I CAN'T SPEAK FOR THE AGENCY, BUT THE UNDERSTANDING IS IS IF THE VACCINES HAD NOT WORKED,... |
| 03:12:00 |
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BUT LOOKING AT IT FROM WHERE YOU ARE TODAY WITH THE FDA, WHAT KIND OF TIMELINE DO YOU THINK YOU AND... |
| 03:12:20 |
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THE WAY, THE WAY WE LOOK AT THIS IS WE HAVE AN H1N1 ADD JEWISH VENTED, OUR GOAL IS TO GET ONE OR ALL,... |
| 03:12:47 |
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YEAH. ARE WE THE ONLY COUNTRY THAT DOESN'T ALLOW THE ADJUVANT? |
| 03:12:54 |
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AT LEAST FOR NOVARTIS, THE ONLY COUNTRY WE DO NOT SUPPLY THESE VACCINES TO IS THE UNITED |
| 03:12:59 |
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ALL RIGHT. |
| 03:13:01 |
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SO IF I COULD JUST COMMENT -- |
| 03:13:03 |
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YEAH, GO AHEAD. |
| 03:13:07 |
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CSL HAS A UNIQUE ADJUVANT AS WELL THAT WE DEVELOPED IN AUSTRALIA, AND WE DID PUT IT INTO THE H5N1... |
| 03:13:18 |
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AND THAT'S WHAT? |
| 03:13:20 |
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THAT'S THE BIRD FLU, THE AVIAN FLU. |
| 03:13:22 |
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GOT IT. |
| 03:13:26 |
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WE ALSO HAVE MULTIPLE RESEARCH PROGRAMS GOING ON UTILIZING OUR ADJUVANT, AND IT'S BEING MANUFACTURED... |
| 03:13:34 |
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SO WE MANUFACTURE IT HERE, WE JUST CAN'T USE IT HERE? |
| 03:13:37 |
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IT'S BEING USED IN CLINICAL TRIALS WITH NEW VACCINES BEING DEVELOPED BY OTHER COMPANIES THAT WE PARTNER... |
| 03:13:44 |
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AND AS YOU'VE USED IT IN OTHER COUNTRIES, IF I UNDERSTOOD YOU CORRECTLY -- |
| 03:13:49 |
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WE'VE DONE THE STUDIES FOR H5N1 IN AUSTRALIA. |
| 03:13:52 |
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AND DID YOU FIND -- |
| 03:13:55 |
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WE FOUND IT TO BE SAFE AND EFFICACIOUS. |
| 03:13:58 |
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WE'RE ALSO ABLE TO PRODUCE MF59 IN THE HOLLY SPRINGS FACILITY IN NORTH CAROLINA TO BE OPERATIONAL... |
| 03:14:03 |
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ALL RIGHT. MY TIME HAS EXPIRED, I KNOW WE HAVE OTHER MEMBERS HERE WHO WANT TO ASK QUESTIONS. THANK... |
| 03:14:12 |
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THANK YOU. I WAS GOING TO ASK, USE MY TIME WITH DR. LAKE KEY HERE BECAUSE YOU'RE THE STATE GUY, AND... |
| 03:15:32 |
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SURE. LET ME PROVIDE SOME BACKGROUND RELATED TO HOW WE DO THIS. WE HAVE THE ACIP GUIDELINES, THE ... |
| 03:16:35 |
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AND JUST TO INTERRUPT YOU, I'VE HAD THAT PHENOMENA, TOO, WHERE ONE OF MY SCHOOL DISTRICTS HAS THE... |
| 03:17:08 |
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SO YOU USE EMPLOYERS AS WELL THE WAY NEW YORK DOES? |
| 03:17:10 |
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WE'RE NOT -- WELL, WE'RE PROVIDING IT TO THE PHYSICIANS, THE HEALTH CARE SYSTEMS -- |
| 03:17:16 |
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SO YOU DON'T ACTUALLY, I KNOW I'M INTERRUPTING YOU, BUT I'M GOING TO RUN OUT OF TIME. YOU DON'T ACTUALLY... |
| 03:17:31 |
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I HAVE 13,000 REGISTERED PROVIDERS ON OUR SYSTEM, AND IT'S A COMBINATION OFMANY OF THOSE. THERE MAY... |
| 03:17:48 |
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DO YOU THINK THAT -- I MEAN, I'M ASKING YOU TO CRITICIZE ANOTHER STATE, BUT WOULD YOU -- NEW YORK,... |
| 03:17:58 |
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WELL, I DON'T KNOW THE DETAILS. |
| 03:17:59 |
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I UNDERSTAND. |
| 03:18:00 |
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OF NEW YORK. FROM WHAT I HAVE GATHERED IS THAT THEY'VE BEEN TRYING TO MEET THE PRIORITY GROUPS AND... |
| 03:18:15 |
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LET ME ASK CROW THIS, YOU DID MENTION THE CHALLENGES OF INTERMITTENT PUBLIC HEALTH FUNDING AND DR.... |
| 03:18:40 |
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SURE. I THINK THERE'S A COUPLE OF ISSUES HERE. ONE IS THE FEDERAL FUNDS THAT HAS BEEN MADE AVAILABLE,... |
| 03:19:21 |
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BUT YOU OBVIOUSLY FEEL THAT IT MAKES SENSE FOR THE STATES TO HAVE A LOT OF DISCRETION HERE. IN OTHER... |
| 03:19:41 |
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I GUESS CLARIFICATION, THAT'S FOR THE FOLKS THAT ARE BEING VACCINATED RIGHT NOW? |
| 03:19:46 |
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IN TERMS OF THE DISTRIBUTION. |
| 03:19:47 |
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THE DISTRIBUTION SYSTEM? I THINK WHERE WE ARE RIGHT NOW FOLKS ARE TIGHTENING UP THOSE GROUPS. I THINK... |
| 03:20:29 |
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ALL RIGHT. THANK YOU. THANK YOU, MR. CHAIRMAN. |
| 03:20:34 |
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MR. SHIMKUS FOR QUESTIONS, PLEASE. |
| 03:20:37 |
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THANK YOU, MR. CHAIRMAN, AND THANK YOU FOR THE PANELISTS FOR BEING HERE. YOU KNOW, WE'VE SPENT A LOT... |
| 03:21:22 |
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YEAH. I CAN EXPLAIN IT. I THINK THERE ARE TWO REASONS FOR THAT. AT MEDIMMUNE WE DEVELOP OUR OWN ... |
| 03:22:43 |
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I CAN TELL YOU WE HAVE MANUFACTURED OVER 100 MILLION DOSES, AND WE COULD EASILY HAVE GONE UP TO 200... |
| 03:22:56 |
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WHAT PIQUED MY INTEREST IS ALSO SOME OF THE COMMENTS WHEN CHAIRMAN BLOWN GOT INTO THE DISCUSSION A... |
| 03:23:20 |
|
THAT'S CORRECT. |
| 03:23:22 |
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I THINK HE MENTIONED SCHOOLS, DIDN'T WANT TO DO A NASAL SPRAY. |
| 03:23:28 |
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I THINK WE ARE NOT, UNIT, WE DO NOT HAVE REGNANT WOMEN IN OUR LABEL AND WE CANNOT ADMINISTER THE INTERNASAL... |
| 03:24:24 |
|
THANK YOU, DR. LAKEY. THE TITLE OF THE HEARING IS AN UPDATE ON VACCINE PRODUCTION AND DISTRIBUTION,... |
| 03:25:05 |
|
THAT IN THE PRIVATE SECTOR, MANUFACTURED, WE ORDER IT AND IT IS SHIPPED. THAT SYSTEM SEEMS TO WORK... |
| 03:25:18 |
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WHAT ELSE DO YOU THINK WE NEED TO DO, BECAUSE YOU PROBABLY LISTEN TO THE OPENING STATEMENT. MY CONCERN... |
| 03:25:37 |
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I GUESS I'VE LEARNED THROUGH OTHER EVENTS SUCH AS HURRICANES, ETC., BUT YOU HAVE TO TAKE TIME AFTERWARDS... |
| 03:26:08 |
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AND I AGREE. MY TIME HAS EXPIRED. THANK YOU, MR. CHAIRMAN. THANK YOU, PALE. |
| 03:26:19 |
|
MR. GREEN, QUESTIONS, PLEASE. |
| 03:26:20 |
|
THANK YOU, MR. CHAIRMAN, AND DR. LAKEY, I APPRECIATE YOU BEING HERE AND GLAD WE GET TO MEET EARLIER.... |
| 03:27:10 |
|
I THINK WHAT YOU SEE OR HAVE SEEN IN TEXAS IS A MOSAIC OF DIFFERENT STRATEGIES WORKING TOGETHER TO... |
| 03:28:13 |
|
CAN YOU TELL US HOW PUBLIC HEALTH EMERGENCY FUNDS HELP YOU AND OTHER STATE PUBLIC HEALTH DEPARTMENT... |
| 03:28:24 |
|
EXCUSE ME, GINTHER? |
| 03:28:27 |
|
HOW THE PUBLIC HEALTH EMERGENCY FUNDS HELP WITH THAT? |
| 03:28:32 |
|
THEY CAME INTO THREE COMPONENTS AND THEY BEEN CRIPPLED TO OUR ABILITY TO RESPOND. THE FIRST PART HAD... |
| 03:29:38 |
|
DR. LEE, I KNOW YOU RELEASED A REPORT ON THE AUTHOR STATES SCHOOL-AGE CHILDREN ARE THE POPULATION... |
| 03:30:27 |
|
ABSOLUTELY. CERTAINLY USING THE SCHOOL-BASED THE SULLEYS FOR BOTH IMMUNIZATIONS AND OTHER TYPES OF... |
| 03:31:04 |
|
MR. CHAIRMAN, I APPRECIATE, MY LAST QUESTION ASKED FOR THE REASON WE'RE HERE TODAY, AND IT IS TO ASK... |
| 03:31:39 |
|
I THINK CELL CULTURE IS NOT AGAIN CHANGE. I WILL STEAL THAT PHRASE. THE GAME CHANGER PROBABLY ALONG... |
| 03:33:10 |
|
SO THE CAPACITIES HERE WHAT IS PRODUCTION IN THE UNITED STATES AND I KNOW WE HAVE ONE PRODUCTION IN... |
| 03:33:21 |
|
I THINK THERE IS AN IMPORTANT DYNAMIC HERE, FOR THE SEXY. BUT WHAT WE SAW WITH THE AVIAN INFLUENZA... |
| 03:34:43 |
|
QUICKLY HERE. |
| 03:34:45 |
|
FOR US, YOU KNOW, THE EGGS ARE WORKING WELL. I THINK IF YOU HAD THE SELF CULTURE TECHNOLOGY ALSO ... |
| 03:35:41 |
|
THANK YOU. MR. BURGESS, FOR QUESTIONS, MENTION YOU'RE ONE OF THE MEMBERS FOR BRITAIN TO MYSELF AND... |
| 03:35:55 |
|
YOUR KIND TO POINT OUT THAT I DIDN'T WIND. YOU JUST FINISH UP ON AN EXCELLENT POINT, DOCTOR LEVITT... |
| 03:36:32 |
|
I WILL RESPOND FIRST. I THINK THAT WE DID NOT, BECAUSE WE DID NOT PARTICIPATE IN THE PANDEMIC RFP... |
| 03:37:40 |
|
SO YOU DID COMMUNICATE THEIR CONFERENCE CALLS? AND THAT WOULD BE IN JUNE. |
| 03:37:43 |
|
YES, SIR. DID. WE COMMUNICATE IN JUNE AND PUT A NEW SCHEDULE TOGETHER IN JULY BASED ON OUR ASSUMPTIONS.... |
| 03:37:50 |
|
WHAT WAS BARTERS EXPERIENCED? |
| 03:37:52 |
|
WITH NOVARTIS, I JUST WANT TO POINT OUT FOR CLOUDY SAKE WE CAN'T CONFIRM DEALS UNTIL WE HAVE RECEIVED... |
| 03:38:12 |
|
MEDIMMUNE IS DIFFERENT, BUT WHAT ABOUT -- |
| 03:38:16 |
|
ACTUALLY THE SAME FOR US IN TERMS OF REALIZING THAT WE FIRST STARTED OUT ON A VERY CONSERVATIVE ESTIMATE... |
| 03:38:37 |
|
I'M A LITTLE CONCERNED BECAUSE I HAD CONVERSATIONS IN AUGUST WITH THE CDC AND NIH AND WAS GIVEN ASSURANCES... |
| 03:39:23 |
|
AT CSO, WHAT WE DID WAS, WHEN WE DID RECEIVE A CALL, WE TOOK ANOTHER LOOK AT OUR ABILITY TO FILL AND... |
| 03:39:57 |
|
AND HE DID THAT AS A RESULT OF THE CALL ON OCTOBER 2019? |
| 03:40:01 |
|
WE WERE EVALUATING ALL ALONG THE WAY, BUT THAT WAS ALSO A CALL TO REINFORCE WHAT WE'VE BEEN DISCUSSING... |
| 03:40:08 |
|
LET ME ASK, WAS A PROBLEMATIC FOR YOU THAT YOU ARE AT THE POINT WHERE YOU WERE GEARING UP FOR THE... |
| 03:40:19 |
|
I THINK IT WAS JUST A COMPRESSION OF THE TIMELINES. WE HAD TO COMPLETE OUR SEASONAL FLU, AT LEAST... |
| 03:40:39 |
|
BUT THERE'S BEEN DIFFICULTY GETTING SEASONAL FLU VACCINE, I KNOW OUR TEAM UNITY HAS BEEN LACKING FOR... |
| 03:40:51 |
|
IN OUR CASE, WE COMPLETED OUR SEASONAL DELIVERY IN EARLY OCTOBER AND. |
| 03:40:58 |
|
MY WAL-MART BACK HOME IS NOT. I KNOW I CAN GET DOMINION, AND I SHOULDN'T DO THAT. BUT OF THE OTHER... |
| 03:41:26 |
|
WE DON'T USE ANY ADJUVANTS. |
| 03:41:27 |
|
BECAUSE YOUR YIELD AND THE METHOD OF IT SUCH THAT THE EULA SO I? |
| 03:41:34 |
|
IT IS BY FAR THE HIGHEST AND IT IS REPLICATING THE NASAL CAP, THAT YOU DON'T NEED AN ADJUVANT. |
| 03:41:40 |
|
DR. LAKEY'S LET ME -- |
| 03:41:43 |
|
THAT WE BE COMPLETED OUR SEASONAL MANUFACTURING ALSO ON TIME. AND EVEN ABLE TO ACCELERATE FOR H1N1.... |
| 03:41:58 |
|
DR. LAKEY, LET ME JUST ASK YOU, BECAUSE TEXAS HAS HAD SOME PROBLEMS WITH SOME OF THEM MADE THEIR WAY... |
| 03:42:13 |
|
I THINK WE LEARNED AS VACCINE WAS COMING OUT THAT IT WASN'T WHAT WE HAD ANTICIPATED, SO EARLY OCTOBER.... |
| 03:42:29 |
|
DO YOU FEEL THAT CDC AND HHS TO SHARE INFORMATION WITH YOU IN A TIMELY FASHION? |
| 03:42:36 |
|
WE'VE HAD MULTIPLE CALLS WITH THE CDC AND THE OFFICES OF THE SECRETARY FOR PREPAREDNESS AND RESPONSE,... |
| 03:42:47 |
|
HAVE THEY BEEN HELPFUL IN HELPING YOU ADAPT TO THE CHANGE IN THE VACCINE AVAILABILITY? |
| 03:42:56 |
|
THE CDC HAS BEEN VERY HELPFUL TO US IN THE STATE OF TEXAS WHEN THERE HAVE BEEN ISSUES THAT HAVE AROSE... |
| 03:43:22 |
|
HOW ABOUT THE MANUFACTURES AND SELLS? SIMILAR RESPONDED WITH INFORMATION WHEN YOU NEEDED IT, OR DIGITAL... |
| 03:43:31 |
|
MY COMMUNICATION GOES THROUGH THE CDC, AND MANUFACTURES WOULD DISCUSS THAT INFORMATION WITH CDC'S.... |
| 03:43:43 |
|
AND UN MR. PALLONE TALKED A LITTLE BIT ABOUT FUNDING. DO YOU HAVE, I GET THE FEELING THAT THE LEVEL... |
| 03:43:58 |
|
THIS IS FOR FIRST FUNDING RIGHT NOW. THEY TALKED TO STATE HEALTH OFFICERS TO FIGURE OUT WHAT THEY... |
| 03:44:47 |
|
YOU'VE INDICATED TO ME THAT YOU SEE A NUMBER OF CASES IS ACTUALLY DIMINISH OVER WHAT IT WAS EVEN JUST... |
| 03:45:20 |
|
THAT IS CORRECT. WE MONITOR THE PERCENTAGE OF BUSINESS TO PHYSICIANS FLOOR INFLUENZA LIKE ILLNESS.... |
| 03:45:50 |
|
MY, I HAVE TO WRAP THIS UP. |
| 03:45:51 |
|
JUST AS A FINAL THOUGHT. WE ARE RIGHT NEXT DOOR TO MEXICO WHICH IS WHERE THIS BEGAN A YEAR AGO, IS... |
| 03:46:10 |
|
I DON'T KNOW IF I CAN INTELLIGENTLY ANSWER THAT. I THINK WE PREDICT THAT THEY WILL HAVE, YOU KNOW,... |
| 03:46:36 |
|
BUT IT DEFINITELY BACK AT US LAST YEAR WHEN THEY BECAME ILL, WE DEVELOP SYMPTOMS VERY QUICKLY IN OUR... |
| 03:46:43 |
|
INFECTIOUS DISEASE DO NOT RESPECT BORDERS, AND IT CAME ACROSS OUR BORDER VERY RAPIDLY. AND THROUGHOUT... |
| 03:47:05 |
|
THANK YOU, DOCTOR. I YIELD BACK, MR. CHAIRMAN. |
| 03:47:09 |
|
WE WILL HAVE VOTES HERE IN A FEW MINUTES, AND WILL FINISH UP WITH SPAM AND FINISH UP IS A. DR. LAKEY,... |
| 03:47:30 |
|
I'M NOT SURE IF, THERE'S PROBABLY SEVERAL FACTORS INTERACTING. THE HISTORY OF PANDEMICS COMING IN... |
| 03:48:05 |
|
SO AS MR. BURGESS SAID, AS WE MOVE ABOUT DURING THIS HOLIDAY SEASON, THAT COULD VERY WELL SPREAD INTO... |
| 03:48:15 |
|
AS WE GET INTO THE COLDER SEASON, AS PEOPLE ARE MORE INSIGHT, AS THE HUMIDITY CHANGES, THE ENVIRONMENT... |
| 03:48:26 |
|
AND WE COULD VERY WELL HAVE |
| 03:48:28 |
|
EXACTLY. |
| 03:48:30 |
|
LET ME ASK YOU ALL THIS QUESTION AND THEN SUMMARIZE. IS MY UNDERSTANDING FROM LISTENING THROUGHOUT... |
| 03:48:57 |
|
YOU ARE ALL NODDING HER HEAD YES REX OKAY. MIKE, ANY OTHER QUESTIONS BEFORE WE CLOSE IT DOWN? |
| 03:49:05 |
|
I AM DISTURBED AT THE SECRETARY SEBELIUS DID INDICATE TO US THAT WE WOULD HAVE TO DO IS THAT WE NEEDED,... |
| 03:50:03 |
|
YES, SIR. THAT WE HAD A ROSY FORECAST OF THE SECRETARY, THAT HAS NOT HELD TO. I THINK BETWEEN THE... |
NOTE: The transcript for this program was compiled from uncorrected Closed Captioning.