| 00:00:06 |
HOST, -
IS ANNA EDNEY, WHO REPORTS ON THE FDA AND OTHER ISSUES FOR BLOOMBERG NEWS. THIS ISSUE STEMMED FROM WHAT IS KNOWN AS A COMPOUND IN PHARMACY. CAN YOU...
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| 00:00:24 |
GUEST, -
TO SEE IF THIS COULD HAVE BEEN PREVENTED. THE PHARMACY HAS BEEN AROUND SINCE 1998, 1999, AND THERE HAVE BEEN COMPLAINTS FROM OTHER STATES, BASICALLY...
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| 00:02:27 |
HOST, -
BOUND PHARMACY OFTEN PROVIDES A CHEAPER ALTERNATIVE -- COMPOUND IN PHARMACY OFFER CHEAPER DRUGS. GUEST: THERE
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| 00:02:42 |
GUEST, -
ARE ABOUT 7500 THAT DO THIS COMPOUND IN, -- COMPOUNDING, AND THE PHARMACIES ARGUE THERE IS A NEED FOR IT BECAUSE THERE ARE PATIENTS THAT ARE ALLERGIC...
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| 00:03:47 |
HOST, -
WHAT HAPPENED AS A RESULT OF THE MENINGITIS OUTBREAK, THAT IS WHAT BROUGHT CONGRESS INTO THE HEARING. IF YOU WANT TO ASK ABOUT THE HEARING AND ISSUES...
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| 00:05:44 |
HOST, -
REPRESENTATIVE THAT WAS PART OF THE QUESTIONING, WITH A SPECIFIC QUESTION REGARDING THE ROLE IN COMPOUNDING PHARMACIES. [VIDEO CLIP] >> COMMISSIONER,
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| 00:05:58 |
Unidentified Speaker, -
TWO AGENCIES DROPPED THE BALL. THE MASSACHUSETTS AGENCY HAD TO FIRE TED BECAUSE HE COULD NOT DO HIS JOB, AND I DO NOT WANT YOU TO BE DEFENSIVE, BUT YOUR...
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| 00:06:41 |
Unidentified Speaker, -
DEFINES IF YOU ARE A MANUFACTURER OR A PHARMACY. >> YOU MAY DEFINED
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| 00:06:46 |
Unidentified Speaker, -
BOTH. YOU HAVE THE AUTHORITY AND YOU DID NOT DO IT. HOST: GOING
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| 00:06:53 |
HOST, -
TO THE LEGAL DEFINITIONS, DOES THAT MEAN CONGRESS? GUEST: THAT IS
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| 00:07:00 |
GUEST, -
SOME OF THE ARGUMENT, THAT ALL OF THE AUTHORITY THAT FDA NEEDS IS ALREADY THERE. FDA FEELS THERE ARE DEFINITIONS THAT NEED TO BE CHANGED, AND THE IDEA...
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| 00:08:58 |
HOST, -
NEW JERSEY. YOU ARE WITH ANNA EDNEY OF BLOOMBERG NEWS. CALLER: GOOD MORNING. CALLER: THIS IS STUFF THAT WE SHOULD HAVE KNOWN ABOUT A MUCH LARGER SCALE....
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| 00:10:53 |
CALLER, -
OF QUESTIONS FOR A ANNA. AND WHAT THE FDA HEARING YESTERDAY. WE HAVE A GOVERNMENT THAT REGULATES ALL OF THESE PARTS OF OUR LIVES. AND WE HAVE PINKS LIVE...
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| 00:12:06 |
GUEST, -
HAS SAID IS THAT THEY DID NOT KNOW THE VOLUME THAT WAS COMING OUT. DID NOT HAVE ACCESS TO THE RECORDS, IS PART OF THEIR ARGUMENT. BECAUSE THE SUPREME...
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| 00:12:52 |
HOST, -
IS A HEADLINE FROM ABC NEWS. GUEST: HE WAS
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| 00:13:00 |
GUEST, -
SUBPOENAED. HE WAS NOT GOING TO SHOW UP ON HIS OWN. THE COMMITTEE SUBPOENAED HIM TO COME IN. HE PLEADED THE FIFTH. HE WAS ASKED A COUPLE TIMES A FEW...
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| 00:13:32 |
HOST, -
C-SPAN.ORG IS WHERE YOU CAN GO IF YOU WANT TO WATCH THE HEARING. GO TO OUR VIDEO LIBRARY AND TYPE IN THE FDA. THAT IS C-SPAN.ORG. SCOTT IS ON OUR REPUBLICAN...
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| 00:13:49 |
CALLER, -
CALLER: THANK YOU FOR TAKING MY CALL. DO YOU KNOW WHAT THE PER-CAPITA- OUTCOMES IS FOR COMPOUNDING PHARMACIES COMPARED TO GLOBAL PHARMACOMPANIES? IS THIS...
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| 00:14:27 |
GUEST, -
NOT HAVE THE ANSWER TO THE PER-CAPITA QUESTION. I DO NOT KNOW THE MOTIVES OF THE LARGER COMPANIES. HOST: AS FAR AS
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| 00:14:40 |
HOST, -
LARGER COMPANIES TO SMALLER COMPANIES, WHAT IS THE RATIO? GUEST: AS FAR AS HOW
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| 00:14:47 |
GUEST, -
MANY OF THEM ARE THERE. 66 -- SIX TO 500 MANUFACTURERS -- 6500 MANUFACTURUERS. -- MANUFACTURERS.
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| 00:15:08 |
HOST, -
HOST: 94 INDEPENDENTS. -- LINE FOR INDEPENDENTS. CALLER: THERE IS NOT
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| 00:15:26 |
CALLER, -
AS THE LOSS THANK YOU HAVE GOT TO GET VACCINATED. -- NO LAW SAYING YOU OF GOT TO GET VACCINATED. IF YOU TAKE THAT INTO CONSIDERATION, AND THE SIDE EFFECTS...
|
| 00:16:03 |
HOST, -
BUT WE WILL LEAVE THEM THERE. HAVE THEY SOURCED WHERE THE TAINTED VACCINES COME FROM? GUEST: THE
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| 00:16:13 |
GUEST, -
STEROIDS? NO. WERE THEY ACTUALLY GOT THE PRODUCT FROM BEYOND THE FOUR MISSING -- COMPANY PHARMACY. HOST: IS THERE A SENSE
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| 00:16:27 |
HOST, -
OF WHAT THESE MANUFACTURING CONDITIONS WERE LIKE? GUEST:
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| 00:16:32 |
GUEST, -
BEHALF RELEASED AN INSPECTION REPORT FOR WHEN THE FDA WENT VERY RECENTLY. IF FOUND MOLD AND BACTERIA. THERE WERE SOME LEAKS AND DIFFERENT THINGS. THE...
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| 00:17:20 |
HOST, -
THERE SOMEONE IDENTIFIED IN THE COMPANY THAT DEALS STRICTLY WITH QUALITY CONTROL?
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| 00:17:24 |
GUEST, -
GUEST: NO. ANYONE NAMED ON THE ACTUAL INSPECTION SHEETS WAS ACTUALLY [INDISCERNIBLE] CALLER: IF WE SAY THAT OUR
|
| 00:17:41 |
CALLER, -
PRESS IS FREE AND OUR OBJECTIVE, THEN WHY IS NOT OUR FREE AND OBJECTIVE PRESS RELATING THESE STORIES EARLIER? WE CANNOT BLAME ANYBODY FOR THIS. THIS...
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| 00:18:23 |
HOST, -
THE COMMISSIONER OF THE FDA,. [VIDEO CLIP] TO >> THE WITHIN THE FDA IS RESPONSIBLE FOR DEFINING THAT? >> IS NOT JUST THE
|
| 00:18:43 |
Unidentified Speaker, -
FDA, IT IS CONGRESS. >> BUT WHO IS THE -- >> ARE CHIEF COUNSEL -- >> HAVE YOU REVIEWED
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| 00:18:55 |
Unidentified Speaker, -
WITH CHIEF COUNSEL THE DEFINITION OF MANUFACTURING VERSUS COMPOUNDING? >> I THINK EVERYONE
|
| 00:19:02 |
Unidentified Speaker, -
AGREES THAT THE PRESENT TIME -- BUT I DID NOT ASK YOU THAT. >> HAVE YOU
|
| 00:19:09 |
Unidentified Speaker, -
REVIEWED THE DEFINITION OF COMPOUNDING VERSUS MANUFACTURING? HAVE YOU REVIEWED THAT WAS SOMEONE? >> WE'VE HAD MANY DISCUSSIONS. >> HAS SOMEONE GIVING...
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| 00:19:20 |
Unidentified Speaker, -
A DEFINITION OF MANUFACTURING VERSUS COMPOUNDING? >> I THINK THAT THERE IS NOT A CLEAR -- >>
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| 00:19:32 |
Unidentified Speaker, -
YES, THERE IS. IF YOU'RE TELLING ME THE CRUX OF YOUR TESTIMONY IS IT NOT HAVE AUTHORITY ON THE MANUFACTURING, YOU MUST HAVE MET WITH SOMEBODY WHO TOLD...
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| 00:19:50 |
Unidentified Speaker, -
THAT YOU ARE FRUSTRATED BY MY ANSWERS. I'M SORRY, BUT I CANNOT GIVE A YES OR NO. THE COURSE OF OUR COUNTRY ARE SPLIT -- THAT IS NOT COMPLEX. COMPLEX...
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| 00:20:12 |
HOST, -
PERCEPTION OF WHAT WAS GOING ON. GUEST: THIS SEEMED
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| 00:20:17 |
GUEST, -
TO BE AN EXCHANGE THAT SHE WAS HAVING WITH EVERY MEMBER. THEY WANTED TO KNOW, WAS NECC MANUFACTURING OR COMPOUNDING. SHE SAID EVERY TIME IT IS A COMPLEX...
|
| 00:20:52 |
HOST, -
STATUTE THAT LAYS THINGS OUT WORD FOR WORD? GUEST:
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| 00:20:57 |
GUEST, -
NO. IT HAS BEEN TO THE COURTS ENOUGH TIMES THAT IT HAS BEEN MODELED UP. THERE WAS A STATUTE, AND THAT IT HAS BEEN TO THE SUPREME COURT. THE RAPID A...
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| 00:21:52 |
HOST, -
ANY OF THESE COMPOUNDS PHARMACIES HAVE A DRUG REPRESENTATIVE THAT GOES TO DOCTORS' OFFICES TO SELL WARE, SO TO SPEAK?
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| 00:22:01 |
GUEST, -
GUEST: YES. THE NECC, THAT IS WHAT SOME OF THE COMPLAINTS WERE ABOUT. THEY WERE SENDING PEOPLE TO THE MARKET TO DO THINGS THAT A DRUG MANUFACTURER WOULD...
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| 00:22:24 |
HOST, -
FOR INDEPENDENTS, ERIC. CALLER:
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| 00:22:28 |
CALLER, -
GOOD MORNING. I THINK THAT IF YOU GET THE PRODUCT FROM THE MANUFACTURER AND YOU CHANGE THE PRODUCT, YOU ARE ALSO MANUFACTURING. HOW CAN THAT NOT BE CLEAR...
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| 00:22:49 |
GUEST, -
THE PHARMACIES SOMETIMES ARE ALLOWED TO EXTRACT -- IF SOMEONE IS ALLERGIC TO A PRESERVATIVE OR A COLOR, THEY ARE ALLOWED TO EXTRACT THAT. IT IS THE...
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| 00:23:46 |
CALLER, -
WE HOLD PEOPLE RESPONSIBLE. WE NEVER HOLD COMPANIES AND CORPORATIONS RESPONSIBLE. I WOULD LIKE TO SEE THEM CRIMINALLY CHARGED. WE CHARGED A 14-YEAR-OLD...
|
| 00:24:50 |
GUEST, -
JUSTICE AND FDA HAVE SAID THE THERE IS A CRIMINAL INVESTIGATION INTO NECC, INTO THE COMPANY. HOST: JASON SAYS,
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| 00:25:00 |
HOST, -
IN THIS INDUSTRY, WOULD NOT COMPOUNDING FALL UNDER FABRICATING REGULATIONS VS MANUFACTURING REGULATIONS? GUEST: THIS IS NOT A QUESTION I AM CLEAR ON....
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| 00:25:23 |
HOST, -
TENNESSEE, REPUBLICANS LINE. CALLER: I'M
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| 00:25:27 |
CALLER, -
GRATEFUL TO TALK TO YOU TODAY. THANK YOU FOR YOUR REPORTING. DO YOU KNOW IF NECC OR OTHER COMPOUND IN COMPANIES LIKE THAT HAVE OWNERSHIP IN OTHER COUNTRIES...
|
| 00:25:48 |
GUEST, -
A QUESTION I DO NOT KNOW ABOUT. HOST: ANDREW, ON OUR DEMOCRATS LINE.
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| 00:25:57 |
CALLER, -
CALLER: GOOD MORNING. MANUFACTURING FOR CONSUMPTION, PROFIT MOTIVE TO THE EXTREME. THEY WILL GO TO SUCH AN EXTENT THAT THE GOVERNMENT ALLOWS THEM TO....
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| 00:26:30 |
HOST, -
A BIT. I DO NOT KNOW IF YOU GRAB ANYTHING FROM THAT. A STORY IN "THE NEW YORK TIMES" THIS WEEK, INITIAL ACTIONS OF CONGRESS LED TO THE CURRENT SITUATION....
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| 00:26:48 |
GUEST, -
COMPOUNDING PHARMACIES DO NOT HAVE A HUGE LOBBYING GROUP. THEY DID HAVE SOME LOBBYING. IT SEEMS TO HAVE BEEN EFFECTIVE. THERE WERE SOME NUMBERS. I DO...
|
| 00:27:27 |
HOST, -
HIGHLIGHTS TWO PICTURES. THIS ONE IS SENATOR TED KENNEDY, AND THAT IT WAS TOM DELAY FROM TEXAS. UNDER THESE PICTURES, SAYING IT WAS SENATOR KENNEDY WHO...
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| 00:27:53 |
GUEST, -
UNDER STATE CONTROL. THAT IS THE WAY IT HAS BEEN FOR A LONG TIME. IT IS BEEN AN EFFECTIVE ARGUMENT. THEY'RE LOBBYING GROUP HAS MADE THAT ARGUMENT FOR...
|
| 00:28:19 |
CALLER, -
A PERSON'S SHOES OR HAVE THE POWER TO CHOOSE WHETHER THEY ARE PURCHASING FROM MANUFACTURING OR COMPOUNDING, IN SUCH CASES AS GARDASIL? LITERATURE'S I...
|
| 00:28:48 |
GUEST, -
ONE OF THE THINGS THAT MARGARET HAMBURG ASKED FOR WHEN SHE WENT BEFORE CONGRESS THIS WEEK WAS, THE COMPOUNDERS HAVE TO LABEL THEIR MEDICATION THAT IS...
|
| 00:29:41 |
HOST, -
THIS QUESTION FROM TWITTER, ARE THERE ENOUGH INSPECTORS TO ENFORCE AT THE FDA, WHETHER COMPOUNDER OR MANUFACTURER? GUEST: THE FDA HAS ALWAYS BEEN
|
| 00:29:54 |
GUEST, -
A RESOURCES RUT. THE HAVE ALWAYS SAID THEY NEEDED MORE. THERE HAS BEEN THE BUDGET BATTLE ON CAPITOL HILL. THEY HAVE SAID THEY MIGHT BE FACING AN 8%...
|
| 00:30:14 |
HOST, -
VIRGINIA, DEMOCRATS' LINE. CALLER: I
|
| 00:30:19 |
CALLER, -
WOULD LIKE TO ASK IF THE YOUNG LADY FEELS THAT OVER THE LAST YEARS, WHEN THE REPUBLICANS HAVE BEEN IN CHARGE, AND THEY HAVE BEEN DEREGULATING ALL BUSINESSES,...
|
| 00:31:32 |
GUEST, -
TO SEPARATE MANUFACTURING AND COMPOUNDING. THE FDA DOES NOT HAVE THE ABILITY TO INSPECT THE COMPOUNDING PHARMACIES. IT IS NOT PART OF THEIR ROUTINE....
|
| 00:32:34 |
HOST, -
THE GENERAL REACTING -- REACTION FROM THE COMPOUNDING MESSY INDUSTRY AS A WHOLE? GUEST: --
|
| 00:32:43 |
GUEST, -
COMPOUNDING INDUSTRY AS A WHOLE? GUEST: THEY HAVE
|
| 00:32:48 |
GUEST, -
PUSHED BACK AGAINST REGULATION. THE HAVE SAID THE FDA HAS HAD THE POWER THAT THEY HAVE NEEDED, BECAUSE NECC WAS INVESTED IN MANUFACTURING. BISHOP OF BEEN...
|
| 00:33:58 |
HOST, -
GO TO CONGRESS TO GET A CLEARER DEFINITIONS?
|
| 00:34:02 |
GUEST, -
GUEST: THERE DOES NOT SEEM TO BE ANOTHER WAY TO GET THOSE DEFINITIONS. RIGHT NOW, THERE IS A POSSIBILITY -- CONGRESS, THE REPUBLICANS PARTICULARLY LOOKING...
|
| 00:34:57 |
HOST, -
INDICATIONS OF PRIVATE LOSSES COMING OUT OF THIS? GUEST: THERE
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| 00:35:01 |
GUEST, -
HAVE BEEN LAWSUITS THAT HAVE BEEN FILED. THEY'RE LOOKING INTO WHETHER THEY MIGHT CONSOLIDATE THEM. HOST: STRENGTHENING
|
| 00:35:09 |
HOST, -
WHAT GOES ON AS FAR AS THEIR INSPECTOR PROCESS IS CONCERNED? GUEST: THEY
|
| 00:35:16 |
GUEST, -
HAVE DONE SOME TEMPORARY THINGS. ONCE THIS STARTED HAPPENING, THEY DECIDED THEY NEEDED TO GO TO THE PHARMACY IN THEIR STATE. THEY HAVE SHUT DOWN OR TEMPORARILY...
|
| 00:35:51 |
HOST, -
HEARING AS WELL. ANYTHING DIFFERENT THAT CAME FROM THAT HEARING THAT COULD EXPAND AND WHAT HAPPENED IN THE HOUSE? GUEST:
|
| 00:35:59 |
GUEST, -
THE SENATE MEETING WAS MORE OPEN TO LEGISLATION. THEY MAY BE MORE WILLING TO HELP PEOPLE. SENATOR ALEXANDER IS FROM TENNESSEE, AND HE IS A REPUBLICAN....
|
| 00:36:45 |
HOST, -
CLIQUE YOU FOR YOUR TIME. TOMORROW WILL BE JOINED BY CARLOS GUTIERREZ, COMMERCE SECRETARY FOR THE BUDGET MINISTRATION, FORMER. -- BUDGET ADMINISTRATION,...
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NOTE: The transcript for this program was compiled from uncorrected Closed Captioning.