| 00:00:04 | THANK YOU, EVERYONE. |
| 00:00:06 | WE -- IT WAS AN EXCELLENT PANEL, A GREAT DISCUSSION, AND WE ACTUALLY REALLY APPRECIATE SO MANY FOLKS, ACTUALLY GERALD HEDDELL AND I WERE TALKING ON HIS WAY OUT OF HERE, I THINK HE WAS MISINTERPRETING TRAFFIC IN WASHINGTON, D. |
| 00:00:18 | C., SO HE STARTED TO RUN A LITTLE BIT. |
| 00:00:20 | I ACTUALLY DO WANT TO THANK COLLECTIVELY ALL THE PANELISTS FOR TODAY. |
| 00:00:25 | THIS WAS FANTASTIC. |
| 00:00:26 | IT'S GOOD TO SEE IT KEEPS GETTING BIGGER. |
| 00:00:29 | IT'S GROWING IN THE RIGHT DIRECTION. |
| 00:00:31 | GETTING A LITTLE NERVOUS ABOUT ROOM SIZE FOR NEXT YEAR. |
| 00:00:34 | BUT, YOU KNOW, AS YOU'VE HEARD THROUGHOUT THE DAY, THE DANGERS OF THE COUNTERFEIT DRUG ISSUE ARE PROMINENT, AND ALTHOUGH WE'VE SEEN STATISTICS AND HEARD THE STORY ABOUT THE MOVEMENT OF COUNTERFEITS WITH THE ONSET OF THE INTERNET AND IT'S INTEREST TO NOTE THESE GRAY MARKETERS AND THE CRIMINAL OPPORTUNITIES HAVE BEEN AROUND FOR QUITE SOME TIME. |
| 00:00:52 | WE HAVE GRATEFUL THE FDA HAS ACTUALLY BEEN THERE TO HELP FIGHT US WITH IT. |
| 00:00:57 | AND SO YOU'RE PROBABLY QUITE FAMILIAR WITH THE FDA'S MEDICINE ALERTS SYSTEM AND THEIR E-MAIL ALERT PROGRAM. |
| 00:01:04 | MANY OF YOU ARE ON IT. |
| 00:01:05 | MANY OF YOU ARE ON OUR SAFE MEDS SYSTEM AS WELL AND WE WORK COLLABORATIVELY WITH FDA AND OTHER REGULATORY AGENCIES. |
| 00:01:13 | THROUGH THE PROGRAM WHICH PSM IS PARTNERED THE USES YOUTUBE, AND VARIOUS SOCIAL MEDIA PANELS FOR WHAT THE PUBLIC NEEDS TO KNOW. |
| 00:01:27 | YOU CAN SEE WITH THIS NOTE, MAKE SURE, IN THIS CASE YOU SEE A VERY PROMINENT NOTICE ABOUT THOSE TYPES OF ISSUES. |
| 00:01:33 | BUT DID YOU KNOW THEY'VE BEEN ON TOP OF THIS SINCE BEFORE THE INTRANET AND THE INTERNET? |
| 00:01:38 | IT'S BEEN QUITE SOME TIME. |
| 00:01:39 | IN 1957, THIS ALERT WAS ISSUED BY THE FDA WITHOUT AN UNDOCUMENTED CANCER TREATMENT THAT ENDANGERED PATIENTS. |
| 00:01:48 | THEY HAD IT POSTED IN POST OFFICES AROUND THE COUNTRY. |
| 00:01:53 | IT'S SLIGHTLY DIFFERENT THAN WHAT WE KEELDEAL WITH TODAY, WE'RE FLOODED WITH INFORMATION. |
| 00:02:00 | THEY TRIED TO GET IT BANNED AND FAILED. |
| 00:02:03 | OBVIOUSLY THESE THREATS PROLIFERATE TODAY IN A GLOBAL ECONOMY WHERE ALMOST ANYTHING INCLUDING COUNTERFEIT MEDICINES CAN BE PURCHASED WITH A FEW CLICKS AND THAT CREATES A SIGNIFICANT AMOUNT OF CHALLENGES. |
| 00:02:13 | I CAN ACTUALLY MENTION IN MY OWN CASE, MY OWN MOTHER -- I ACTUALLY LEFT IT SOMEWHERE -- HAS RECENTLY ACTUALLY RECEIVED IN THE MAIL HER OWN NOTICE. |
| 00:02:22 | THIS WAS PROBABLY THE WORSE THING THAT COULD HAVE HAPPENED BECAUSE HER SON IS GOING TO BE A PART OF A CONFERENCE AND SHOW IT ALL OVER THE INTERNET AS TIME COMES. |
| 00:02:29 | BUT IT'S THESE TYPES OF AWARENESS WHERE IT'S JUST WIDESPREAD, ANY OPPORTUNITY POSSIBLE, FOR, YOU KNOW, A GLOBAL PHARMACY, BY THE WAY, THAT SAYS IT'S REPRESENTING CANADA BUT HAS BEEN NOTIFIED BY HEALTH CANADA FOR MULTIPLE YEARS THAT IT IS NOT PRESENT AND ACTUALLY SHOULD BE SHUT DOWN. |
| 00:02:45 | AND YET THEY'RE STILL ACTUALLY PROVIDING THAT OPPORTUNITY TO EVEN MY OWN MOTHER. |
| 00:02:49 | AND SO THIS BECOMES MUCH MORE PERSONAL AS WE'VE ALWAYS TALKED ABOUT. |
| 00:02:52 | THIS IS NOT ABOUT SORT OF BOTTOM LINES. |
| 00:02:54 | THIS WAS TALKED ABOUT IN THE INDUSTRY PANEL. |
| 00:02:56 | IT'S ABOUT A PERSONAL IMPACT ON PATIENTS AND WHAT THAT MEANS. |
| 00:03:02 | SO TODAY WHAT THE PARTNERSHIP HAS BROUGHT TOGETHER ALL THESE FOLKS MAKING SURE THE DIALOGUE CONTINUES. |
| 00:03:07 | 100 YEARS SINCE THE FDA'S BIRTH, THE QUESTION REMAINS, HOW DO WE KEEP PEOPLE SAFE FROM UNSAFE PRODUCTS? |
| 00:03:14 | TO ANSWER THE COMPLICATED QUESTIONS, I'D LIKE TO TURN TO THE PREMIERE ORGANIZATION OF THE UNITED STATES AND FRANKLY THE WORLD WORKING TO COMBAT ILLEGAL MEDICINE MEDICINES. |
| 00:03:27 | WE'VE HEARD FROM A NUMBER OF COLLEAGUES SUCH AS JOHN ROTH. |
| 00:03:29 | TO ANSWER, FOR THE LAST THREE YEARS, COMMISSIONER MARGARET HAMBURG LED THE AGENCY'S TRANSFORMATION AND GROWTH FOR PROTECTING AMERICANS AGAINST DOMESTIC THREATS TO A GLOBAL REGULATORY AGENTCY WITH A FOCUS OF HOW TO EXTEND BEYOND OUR BORDERS AND NEVER-ENDING STRUGGLE TO COMBAT UNSAFE AND COUNTERFEIT PRODUCTS. |
| 00:03:51 | IN JUST A FEW SHORT YEARS THE COMMISSIONER HAS PROVEN TO BE A VISIONARY LEADER AND DEDICATION AND FOCUS HELPED THE FDA MAKE GREAT STRIDES IN THE BATTLE. |
| 00:03:59 | WELCOME ME IN JOINING A TRUE PARTNER WITH THE GREATEST ALLY IN THE FIGHT AGAINST COUNTERFEIT |
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