Keep Us Strong WikiLeaks logo

Currently released so far... 97115 / 251,287

Articles

Browse latest releases

Browse by creation date

Browse by origin

A B C D F G H I J K L M N O P Q R S T U V W Y Z

Browse by tag

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
ETRD EAGR ETTC EAID ECON EFIN ECIN EINV ELAB EAIR ENRG EPET EWWT ECPS EIND EMIN ELTN EC ETMIN EUC EZ ET ELECTIONS ENVR EU EUN EG EINT ER ECONOMICS ES EMS ENIV EEB EN ECE ECOSOC EK ENVIRONMENT EFIS EI EWT ENGRD ECPSN EXIM EIAD ERIN ECPC EDEV ENGY ECTRD EPA ESTH ECCT EINVECON ENGR ERTD EUR EAP EWWC ELTD EL EXIMOPIC EXTERNAL ETRDEC ESCAP ECO EGAD ELNT ECONOMIC ENV ETRN EIAR EUMEM ENRGPARMOTRASENVKGHGPGOVECONTSPLEAID EREL ECOM ECONETRDEAGRJA ETCC ETRG ECONOMY EMED ETR ENERG EITC EFINOECD EURM EENG ERA EXPORT ENRD ECONEINVETRDEFINELABETRDKTDBPGOVOPIC EGEN EBRD EVIN ETRAD ECOWAS EFTA ECONETRDBESPAR EGOVSY EPIN EID ECONENRG EDRC ESENV ETT EB ENER ELTNSNAR ECHEVARRIA ETRC EPIT EDUC ESA EFI ENRGY ESCI EE EAIDXMXAXBXFFR EETC ECIP EIAID EIVN EBEXP ESTN EING EGOV ETRA EPETEIND ELAN ETRDGK EAIDRW ETRDEINVECINPGOVCS EPEC ENVI ELN EAG EPCS EPRT EPTED ETRB EUM EAIDS EFIC EFINECONEAIDUNGAGM EAIDAR ESF EIDN ELAM EDU EV EAIDAF ECN EDA EXBS EINTECPS ENRGTRGYETRDBEXPBTIOSZ EPREL EAC EINVEFIN ETA EAGER EINDIR ECA ECLAC ELAP EITI EUCOM ECONEFINETRDPGOVEAGRPTERKTFNKCRMEAID EARG ELDIN EINVKSCA ENNP EFINECONCS EFINTS ECCP ETC EAIRASECCASCID EINN ETRP EAIDNI EFQ ECOQKPKO EGPHUM EBUD ECONEINVEFINPGOVIZ ENERGY ELB EINDETRD EMI ECONEFIN EIB EURN ETRDEINVTINTCS EIN EFIM ETIO ELAINE EMN EATO EWTR EIPR EINVETC ETTD ETDR EIQ ECONCS EPPD ENRGIZ EISL ESPINOSA ELEC EAIG ESLCO EUREM ENTG ERD EINVECONSENVCSJA EEPET EUNCH ECINECONCS ETRO ETRDECONWTOCS ECUN EFND EPECO EAIRECONRP ERGR ETRDPGOV ECPN ENRGMO EPWR EET EAIS EAGRE EDUARDO EAGRRP EAIDPHUMPRELUG EICN ECONQH EVN EGHG ELBR EINF EAIDHO EENV ETEX ERNG ED
KMDR KPAO KPKO KJUS KCRM KGHG KFRD KWMN KDEM KTFN KHIV KGIC KIDE KSCA KNNP KHUM KIPR KSUM KISL KIRF KCOR KRCM KPAL KWBG KN KS KOMC KSEP KFLU KPWR KTIA KSEO KMPI KHLS KICC KSTH KMCA KVPR KPRM KE KU KZ KFLO KSAF KTIP KTEX KBCT KOCI KOLY KOR KAWC KACT KUNR KTDB KSTC KLIG KSKN KNN KCFE KCIP KGHA KHDP KPOW KUNC KDRL KV KPREL KCRS KPOL KRVC KRIM KGIT KWIR KT KIRC KOMO KRFD KUWAIT KG KFIN KSCI KTFIN KFTN KGOV KPRV KSAC KGIV KCRIM KPIR KSOC KBIO KW KGLB KMWN KPO KFSC KSEAO KSTCPL KSI KPRP KREC KFPC KUNH KCSA KMRS KNDP KR KICCPUR KPPAO KCSY KTBT KCIS KNEP KFRDCVISCMGTCASCKOCIASECPHUMSMIGEG KNNB KGCC KINR KPOP KMFO KENV KNAR KVIR KDRG KDMR KFCE KNAO KDEN KGCN KICA KIMMITT KMCC KLFU KMSG KSEC KUM KCUL KMNP KSMT KCOM KOMCSG KSPR KPMI KRAD KIND KCRP KAUST KWAWC KTER KCHG KRDP KPAS KITA KTSC KPAOPREL KWGB KIRP KJUST KMIG KLAB KTFR KSEI KSTT KAPO KSTS KLSO KWNN KPOA KHSA KNPP KPAONZ KBTS KWWW KY KJRE KPAOKMDRKE KCRCM KSCS KWMNCI KESO KWUN KPLS KIIP KEDEM KPAOY KRIF KGICKS KREF KTRD KFRDSOCIRO KTAO KJU KWMNPHUMPRELKPAOZW KEN KO KNEI KEMR KKIV KEAI KWAC KRCIM KWCI KFIU KWIC KCORR KOMS KNNO KPAI KBWG KTTB KTBD KTIALG KILS KFEM KTDM KESS KNUC KPA KOMCCO KCEM KRCS KWBGSY KNPPIS KNNPMNUC KWN KERG KLTN KALM KCCP KSUMPHUM KREL KGH KLIP KTLA KAWK KWMM KVRP KVRC KAID KSLG KDEMK KX KIF KNPR KCFC KFTFN KTFM KPDD KCERS KMOC KDEMAF KMEPI KEMS KDRM KEPREL KBTR KEDU KNP KIRL KNNR KMPT KISLPINR KTPN KA KJUSTH KPIN KDEV KTDD KAKA KFRP KWNM KTSD KINL KJUSKUNR KWWMN KECF KWBC KPRO KVBL KOM KFRDKIRFCVISCMGTKOCIASECPHUMSMIGEG KEDM KFLD KLPM KRGY KNNF KICR KIFR KM KWMNCS KAWS KLAP KPAK KDDG KCGC KID KNSD KMPF KPFO KDP KCMR KRMS KNPT KNNNP KTIAPARM KDTB KNUP KPGOV KNAP KNNC KUK KSRE KREISLER KIVP KQ KTIAEUN KPALAOIS KRM KISLAO KWM KFLOA
PHUM PINR PTER PGOV PREL PREF PL PM PHSA PE PARM PINS PK PUNE PO PALESTINIAN PU PBTS PROP PTBS POL POLI PA PGOVZI POLMIL POLITICAL PARTIES POLM PD POLITICS POLICY PAS PMIL PINT PNAT PV PKO PPOL PERSONS PING PBIO PH PETR PARMS PRES PCON PETERS PRELBR PT PLAB PP PAK PDEM PKPA PSOCI PF PLO PTERM PJUS PSOE PELOSI PROPERTY PGOVPREL PARP PRL PNIR PHUMKPAL PG PREZ PGIC PBOV PAO PKK PROV PHSAK PHUMPREL PROTECTION PGOVBL PSI PRELPK PGOVENRG PUM PRELKPKO PATTY PSOC PRIVATIZATION PRELSP PGOVEAIDUKNOSWGMHUCANLLHFRSPITNZ PMIG PREC PAIGH PROG PSHA PARK PETER POG PHUS PPREL PS PTERPREL PRELPGOV POV PKPO PGOVECON POUS PGOVPRELPHUMPREFSMIGELABEAIDKCRMKWMN PWBG PMAR PREM PAR PNR PRELPGOVEAIDECONEINVBEXPSCULOIIPBTIO PARMIR PGOVGM PHUH PARTM PN PRE PTE PY POLUN PPEL PDOV PGOVSOCI PIRF PGOVPM PBST PRELEVU PGOR PBTSRU PRM PRELKPAOIZ PGVO PERL PGOC PAGR PMIN PHUMR PVIP PPD PGV PRAM PINL PKPAL PTERE PGOF PINO PHAS PODC PRHUM PHUMA PREO PPA PEPFAR PGO PRGOV PAC PRESL PORG PKFK PEPR PRELP PREFA PNG PGOVPHUMKPAO PRELECON PINOCHET PFOR PGOVLO PHUMBA PRELC PREK PHUME PHJM POLINT PGOVPZ PGOVKCRM PGOVE PHALANAGE PARTY PECON PEACE PROCESS PLN PRELSW PAHO PEDRO PRELA PASS PPAO PGPV PNUM PCUL PGGV PSA PGOVSMIGKCRMKWMNPHUMCVISKFRDCA PGIV PRFE POGOV PEL PBT PAMQ PINF PSEPC POSTS PHUMPGOV PVOV PHSAPREL PROLIFERATION PENA PRELTBIOBA PIN PRELL PGOVPTER PHAM PHYTRP PTEL PTERPGOV PHARM PROTESTS PRELAF PKBL PRELKPAO PKNP PARMP PHUML PFOV PERM PUOS PRELGOV PHUMPTER PARAGRAPH PERURENA PBTSEWWT PCI PETROL PINSO PINSCE PQL PEREZ PBS

Browse by classification

Community resources

courage is contagious

Viewing cable 08BEIJING2155, SFDA'S TREATMENT OF BAXTER IN CHINA

If you are new to these pages, please read an introduction on the structure of a cable as well as how to discuss them with others. See also the FAQs

Understanding cables
Every cable message consists of three parts:
  • The top box shows each cables unique reference number, when and by whom it originally was sent, and what its initial classification was.
  • The middle box contains the header information that is associated with the cable. It includes information about the receiver(s) as well as a general subject.
  • The bottom box presents the body of the cable. The opening can contain a more specific subject, references to other cables (browse by origin to find them) or additional comment. This is followed by the main contents of the cable: a summary, a collection of specific topics and a comment section.
To understand the justification used for the classification of each cable, please use this WikiSource article as reference.

Discussing cables
If you find meaningful or important information in a cable, please link directly to its unique reference number. Linking to a specific paragraph in the body of a cable is also possible by copying the appropriate link (to be found at theparagraph symbol). Please mark messages for social networking services like Twitter with the hash tags #cablegate and a hash containing the reference ID e.g. #08BEIJING2155.
Reference ID Created Released Classification Origin
08BEIJING2155 2008-06-04 08:49 2011-08-23 00:00 UNCLASSIFIED//FOR OFFICIAL USE ONLY Embassy Beijing
VZCZCXRO0749
PP RUEHCN RUEHGH RUEHVC
DE RUEHBJ #2155/01 1560849
ZNR UUUUU ZZH
P 040849Z JUN 08
FM AMEMBASSY BEIJING
TO RUEHC/SECSTATE WASHDC PRIORITY 7714
INFO RUEAUSA/DEPT OF HHS WASHINGTON DC
RUEHOO/CHINA POSTS COLLECTIVE
RUEATRS/DEPT OF TREASURY WASHDC
RUCPDOC/DEPT OF COMMERCE WASHDC
RHEHNSC/NSC WASHDC
UNCLAS SECTION 01 OF 03 BEIJING 002155 
 
HHS FOR OGHA/STEIGER AND PASS TO FDA/LUMPKIN 
STATE PASS USTR FOR STRATFORD/WINELAND/READE/WINTERS 
NSC FOR SHRIER/TONG 
 
SENSITIVE 
SIPDIS 
 
E.O. 12958: N/A 
TAGS: ECON EAGR ETRD HHS PREL CH
SUBJECT: SFDA'S TREATMENT OF BAXTER IN CHINA 
 
(U)THIS MESSAGE IS SENSITIVE BUT UNCLASSIFIED. 
PLEASE HANDLE ACCORDINGLY. NOT FOR INTERNET 
DISTRIBUTION 
 
 
1.  (SBU)  SUMMARY: Representatives of Baxter 
Healthcare (protect) visited the U.S. Embassy 
in Beijing to present their concerns about the 
deterioration of relations with China's State 
Food and Drug Administration (SFDA) amid 
concerns that the agency may try to shift 
responsibility for the heparin problem away 
from China, to the detriment of Baxter.  END 
SUMMARY 
 
UNANNOUNCED INSPECTIONS 
------------------------ 
2.  (SBU)  On May 27, three representatives of 
Baxter Healthcare, including Stanley Lau 
(protect), the General Manager for Baxter in 
China, Marie Kissel (protect), the Regional 
Director for Government Affairs, and Charles 
Chen (protect), an Assistant General Counsel, 
visited the U.S. Embassy in Beijing to brief 
HHS Health Attache and Econoff.  The company 
presented concerns about the deterioration of 
relations with China's State Food and Drug 
Administration (SFDA) and the possibility that 
the SFDA may be looking to retaliate for 
perceived uncooperative behavior when SFDA 
staff visited the company's Cherry Hill 
facility in April. COMMENT: This SFDA visit, to 
the facility where Baxter's recalled heparin 
sodium U.S.P. was manufactured, followed the 
April 17-18 International Regulators Meeting on 
Heparin in Washington DC sponsored by the U.S. 
Food and Drug Administration (FDA) which 
gathered heparin experts and representatives 
from 12 different drug-regulating authorities 
to discuss the ongoing heparin investigation 
and its methodology. END COMMENT. 
 
3.  (SBU) General Manager Stanley Lau stated 
that Baxter's plant in Guangzhou has been 
investigated twice in recent weeks by two 
separate SFDA ''flying-squad'' teams.  Unlike 
previous visits, when the local FDA had been 
notified and informed of a pending inspection, 
the SFDA inspectors arrived unannounced and 
without informing the local FDA about the 
inspection.  The manner and tone of the 
investigators was aggressive and the inspectors 
seemed not to listen to any of the explanations 
offered by the facility managers.  The first 
investigation yielded a laundry list of 20 
problems at the facility and the second cited 
five problems (3 as being critical and 2 listed 
as major). 
 
SFDA APPEARS TO CUT OFF COMMUNICATION 
--------------------------------------- 
4.  (SBU) Stanley Lau stated that relations 
with SFDA were positive until a small SFDA 
group traveled to the Baxter plant in Cherry 
Hill, New Jersey in April 2008.  In traveling 
to the U.S. to attend the International 
Regulators Meeting on Heparin, the SFDA team 
had hoped to gain some insight into downstream 
segments of the heparin market.  The SFDA 
requested the Cherry Hill plant visit in an 
informal late night call placed to Baxter, and 
the FDA learned a few days in advance of the 
proposed visit when Baxter called to discuss it 
with them.  SFDA officials attending the FDA- 
sponsored International Regulators meeting on 
heparin were informed by the FDA in advance 
that they would not have the legal right to 
demand drug production samples (as the product 
was neither sold in China nor regulated by 
SFDA).  During the SFDA visit, Baxter expressed 
its preference to provide samples through 
official USG channels.  When SFDA was not able 
to obtain heparin samples on site, relations 
appeared to sour.  NOTE: During the recent 
 
BEIJING 00002155  002 OF 003 
 
 
February FDA inspection at Baxter's affiliated 
plant, Changzhou SPL, where SFDA was an 
observer, FDA investigators asked and received 
samples of specifically requested production 
lots held at the plant.  The SFDA similarly 
requested and later received samples from these 
same lots. END NOTE.  SFDA officials told 
Baxter privately at the Cherry Hill facility 
that they could not "get to" Baxter through the 
U.S. but they have total authority in China. 
 
5.  (SBU) Baxter employees said that through 
some miscommunication, the SFDA team also came 
away from the meeting at Cherry Hill with the 
mistaken impression that records related to the 
incident had been destroyed (as reported by the 
Chinese side).  Baxter tried to provide related 
documents to SFDA and was told to use official 
channels in all future contact with the 
government agency. 
 
6.  (SBU) Since then, on April 22 and April 29, 
the company tried to follow up with SFDA to 
provide the requested additional paperwork 
(redacted medical records of those patients 
suffering from the adverse allergic drug- 
reactions).  These documents were sent by 
Baxter to SFDA via courier, and the first 
shipment seemed to have been received; the 
second shipment was refused and returned. 
Baxter also indicated that it asked SFDA for a 
specific address to ship the requested samples, 
but SFDA has not answered Baxter on where the 
samples should be sent.  To date, no production 
samples have been shared by Baxter due to this 
lack of a specific recipient and address 
provided by SFDA.  In the subject meeting, 
Baxter indicated its preference to provide the 
sample to the FDA, which might retain a portion 
as a control sample and then have FDA ship it 
directly to SFDA. 
 
7.  (SBU) Baxter believes SFDA  working level 
authorities are taking out their frustrations 
over miscommunication and the visit to the 
Cherry Hill plant.  Those officials who visited 
the Cherry Hill facility are affiliated with 
SFDA's National Institute for the Control of 
Pharmaceutical and Biological Products (NICPBP) 
and were responsible for performing the tests 
on heparin samples to determine whether there 
was, or was not contaminant present in the 
samples tested in China. 
 
8.  (SBU) Baxter requested in the subject 
meeting whether the Health and Human Services 
Attache could personally deliver requested 
production samples to the appropriate SFDA 
office.  The HHS Attache agreed to check with 
FDA about this, and expressed concern over the 
chain of custody in doing so, but promised to 
get back to Baxter.  Baxter hopes to maintain 
constructive ties with SFDA authorities on both 
sides and to get through the current impasse. 
 
 
DRUG SAFETY LOOPHOLES STILL APPARENT 
------------------------------------- 
9.  (SBU)  Under current regulations, 
pharmaceutical companies in China that 
manufacture only for the export market are not 
subject to the authorities and regulations of 
SFDA, since the product would not be used in 
the domestic China market.  Moreover, certain 
pharmaceutical ingredients that are declared or 
classified as chemicals are not subject to SFDA 
regulations and authorities either, even if 
their only real applications are in 
pharmaceuticals. This issue, regulation of 
active pharmaceutical ingredients (API), and 
the apparent black-hole this represents in the 
normally tightly-controlled regulatory 
environment for pharmaceuticals, was discussed 
during the negotiations that occurred between 
 
BEIJING 00002155  003 OF 003 
 
 
SFDA and HHS/FDA last fall leading up to the 
signing of the Memorandum of Agreement for Drug 
and Medical Product Safety at December 2007's 
SED.  Vice Premier Wu Yi in her closing remarks 
at the December 2007 JCCT even noted this lack 
of control and regulation of APIs as a concern 
that needed to be addressed by China and 
indicating that the State Council would likely 
begin to address this in the coming year. 
 
A SHIELDING STRATEGY AT SFDA? 
------------------------------ 
10.  (SBU) COMMENT: The heparin incident and 
the aforementioned loopholes have created a 
liability and public opinion problem for which 
the SFDA is reluctant to take responsibility. 
In its press statements, the SFDA has 
continually indicated that the heparin-issue is 
an American problem, as the plant in question 
(Changzhou SPL) is an American joint-venture 
manufacturing its heparin sodium U.S.P. solely 
for export to its parent American firm, for use 
by Baxter.  SFDA has reiterated that the China- 
based plant was neither under SFDA 
responsibility nor regulation. The aftermath of 
the 2007 food and product scare, as well as the 
internal shakeup of SFDA in 2006-7 and the 
execution of the SFDA Commissioner last year 
have weakened the SFDA to the point that it has 
little political capital to expend.  Further 
deterioration of the SFDA's credibility would 
have a major impact for consumer confidence in 
China as a safe source of pharmaceuticals.  It 
appears possible that concerned officials may 
try to shift or spread blame in order to shield 
the agency from further criticism and in order 
to protect China's image among consumers.  A 
recent decision to bring SFDA back under the 
Ministry of Health (MOH) is part of a 
government-wide plan to streamline and 
coordinate authorities while intensifying 
regulation of drug products.  This change, an 
outcome of the March 2007 National Party 
Congress (NPC), will likely enhance SFDA's 
ability to enforce drug regulations and to 
develop a stronger regulatory framework with 
the MOH. END COMMENT. 
 
PICCUTA