Académique Documents
Professionnel Documents
Culture Documents
30,2010
You have no reasonable expectation of privacy regarding any communications or data transiting or
stored on this information system. At any time, and for any lawful goverment purpose, the
government may monitor, intercept, and search and seize any communication or data transiting or
stored on this information system.
Appendix I: Relevant Documents
Page 6 The Honorable Darrelllssa
6. State the purpose of the agency's surveillance of the FDA Nine.
FDA initiated monitoring of the government-owned computers of the fve individuals identified
above for two principal purposes: I) to identify the source of the unauthorized disclosures, if
possible; and 2) to identif any further such unauthorized disclosues so as to better enable FDA
to facilitate their cessation.
Your letter states that "it appears that FDA targeted these employees for surveillance because
they talked to Congress." Beginning as early as October 2008, FDA had begun receiving letters
and other inquires from multiple Congressional offces regarding concerns brought to them hy
various members of the group of individuals you reference. These inquiries made clear that
CDRH personnel were seeking the intervention of Congress. Nonetheless, it was not until
approximately 18 months aer FDA began to receive such inquiries that the montoring of Dr.
Smith's government-owned computer activity was initiated. The impetus for the monitoring was
not any communication to Congress. Rather, the impetus for monitoring was the March 2010
Times article and the receipt of the GE Healthcare letter just prior to the initiation of monitoring,
which indicated that the preceding pattern of similar unauthorized disclosures of confidential
information from other pending medical device applications and submissions was continuing
unabated. It should also be noted that, in conducting the computer monitoring, data were
collected without regard to the identity of the individuals with whom the user may have been
corresponding.
7. Explain the legal justification relied on by FDA to Initiate surveillance of the FDA Nine.
As explained above, this matter is the subject of current litigation. It should be noted, however,
as described above, that since 2009 all users of the FDA computer network have received notice
upon logging in that they should have no reasonable expectation of privacy when utilizing the
FDA computer system. Please see footnote I for the text of the infOlmation that all users
receive.
You have also requested documents, and we have restated below your requests, followed by our
responses.
1. Documents referring or relating to the FDA Nine collectively or individually, including,
but not limited to, all communications to or from Gregory Campbell, Dr. Jefrey
Shuren, Ruth McKee, Ralph Tyler, or Dr. Joshua Sharfstein.
Any communications or data transiting or stored on this information system may be disclosed or used
for any lawfl government purpose.
The above warning has been in continuous use since at least September 20 10, and a similar warning was in lise at
the time the monitoring, as described herein, was initiated. Additionally, all FDA personnel are required to receive
Computer Security Awareness Training annually, during which they are reminded, among other things, that all
network activity may be monitored. The employees abollt whom you have inquired reLeiNed such annual training.
Appendix I: Relevant Documents
Page 7 The Honorable Darrell Issa
FDA is continuing to gather responsive documents, which will be provided in a rolling
production.
2. Documents created or obtained as a result of e-mail monitoring since January 1,2009,
including but not limited to all documents in the file named "FDA 9."
As noted above, FDA did not commence the computer monitoring discussed above until various
dates in 2010. The Agency is continuing to gather responsive documents, which will be
provided in a roling production.
3. Guidance from the Office of the General Counsel referring or relating to monitoring
employee e-mail accounts.
We are working to identify any documents that may be responsive to this request.
4. Guidance from the Office of the Inspector General referring or relating to monitoring
employee e-mail accounts.
We are not aware of documents provided to FDA by oro that provide general guidance, with
respect to the monitoring of employee e-mail accounts.
Thank you, again, for contacting us concerning this matter. rf you have further questions, please
let us know.
cc: The Honorable Elijah E. Cummings
Ranking Member
Sincerely,
Jeanne Ireland
Assistant Commissioner
for Legislation
Committee on Oversight and Government Reform
Appendix I: Relevant Documents
To:
CC:
From:
ntcrmRe_ortotnvcstgaton
Lr Davis, Chief Inforaton Offcer
Joe Albaugb, Chief Inforaton Security Offcer
Joe HooEagle, Incident Response and Forensic Lead; Christopber Newsom,
Incident Response and Forensic Investgator
Date:
June 3, 2010
Subject:
Inte Report of Investtons * Robert C. SMITH
In Ma
y
of 2010 specifc allegatons were presented to the FDA Securty Deparunent regarding
Robert C. SMITH, Medical Offcer - CDRH/ODE/DRAR. Tese aletons
p
ertaied to the
following:
SMITH comunicatg with exteral news souces (press) rearding H1S concers over the
FDA s approval process of patcu medcal devices suuounding C1' scans and
colonograpby. 1 allegaton partculy related to Gardier Hats, reporter for the New
York Times.
The Security Departent bas itated a revew of FDA data sources associated witi1 SMITH to
determe the validity of the allegatons. The anaytc fdg to chte .ppear to sJppor the
allegatons, however the review is ongoing and s\bstanta volumes of ct are currently being culled.
The subordnate informaton that lollows contains:
Communicatons with exteral press souces, including Gardiner Harris, reporter for <e
New York Tie,
Mr. M McCor:acK,
Special Agent in Charge
MAY 1 8 2010
U.S. Department ofHeaHh and Hu.'11an Serices
Food and Drug AdmisLton
Ofce of Crimnal Investigations
Ofce of Interal Afairs
1 Church Street, @
Rockille, : 20850
R: Case :-;a:e: Cnauborzd Disclosure of Information
or File #: Hl 00001413
SAC McCom1ack:
Ofce oflpecor Genera
Ofc ofInvetigtons
Speial Investgatons Brnch
. Wahon, D.C. 20201
TIle U.S. Depaent of Heat ad Ha Services (HS), Ofce of Inspector Genera (OIG), Ofce
of Investgations (01), Special Investigations Branch (SIB), i i receipt of your referra (OI File #:
201 0-01A-970-073). A ts tme, based on te information provided, O1GIOUSI wi be takng no
aotoI Tne referT lci:> my cibnee of criminal conduct on te a of ay HS employee.
Additonally, 5 US.C. :21 idetes that disclosures, such a te ones ege . wnen they rlte
ms of public safety may be mde to the medi and Congess as long as the material release is not
speciiiclly prhbited by law and protected by Executve Order or Naton Secli-ity Classifcaton:
The OIG is appreoiativ of your suppor in its overall mission. Ta yon for cntacting the OIG on this
a:Y questions, or ned ay additonal iormation. please fel fee .e:ert::t
-
Scott A. Vantease
Assistant Spcial Agent i Charge
Special Investigations Branch
= _ ,
!
i
i
ncereIY,
fhuren, M. D. , J. D.
Director, Center for Devices
and Radiological Health
Food and Drug Administration
Appendix I: Relevant Documents
.
Mr. avid Mehring
Special Agent
Ofce of the Inspector General
Department of Health and Human Serices
Avenue SW
Washington, DC 2020 I
Re: Dr. Robert Smith
Dear Mr. Mehring:
U.S. Department of Justic.
Criminal Division
lVa.fllilglCH, DC l0j(
NOV 3 2010
Tle Public Integrity Section has revewed the above-referenced mate in which
there were alleged violations of Title 1 8, United States Code, Section 1905, peretrated by Dr.
Robert Smith and other employees oflhe Food a Drug Administation's Center for Devices
and Radiological Health. Afer reviewing this matter, we have decided to decline prosecuton .
We understand that your ofice concurs with this decision.
I you have any questions regarding this matter, please contact me
Tank you for your coo
p
eration in tis matter.
Sincerely,
Jack SmIth
P2
Pl
Chief
Public Integrity Section
I
Appendix I: Relevant Documents
Y`
DEPARTMENT OF HEALTH Al'HUAN SERVICES
Knowingly allow her subordinates to issue written threats of disciplinary action if physicians
and scientists failed to change their scientific opinions and recommendations to confolm to
those of management;
Issue illegal inte1'l1al documents that do not conform to the requirements of Good Guidance
Practices,
6
are not publicly available, and, iffollowed, would circumvent science and legal
regulatory requirements;
Fail to properly document signifcant decisions in the administrative fles;
7
Allow manufacturers t market devices that have never been approved by FDA;
Remove Black Box wa1'ings recommended by FDA experts;
Bypass FDA experts and fail to properly label devices; and
See http://change.gov/agendal
See letter to Dr. Andrew von Eschenbach dated September 29, 200S.
See http://energycommerce.house.govlimageslstories/DocumentsIPDF !Newsroom/IIOltr-
1 1 1708.vonEschenbach.CDRH.pdf
'
See http://www.fda.gov/ohrms/dockets/ac/08Ibriefng20084349b 1-
01 %20FDA %20Radiological%20Devices%20Panel%20Meeting%20Introd.pdf at pages 52-56.
0
See rd. at pages 42 and 52-56.
'
See 21 CFR S60.7.
18
See http://www.fda.gov/CDRHAlL\10GRAPH/scorecard.statistics.html
See htlp:llwww.accessdata.fda.gov/scripts/cdrhicfdocslcfAdvisor/details.cfn?mtg-694
' See http://www. whistleblowers.orgindex.php?optioncom cOJltent&taskview&id695&Itemid 1 00
'
See the December 200S Report fm the Union of Concered Scientists, Federal Science and the Public Good
Securing the Integrita/Science ill Palicymaking, available at
ht://www .ucsusa.orglassets/documentslscientific integritlFederal-Science-and-the-PublicGood-12-0S-Update. pdf.
See http://www.fda.gov/cdrh/strategic/tplc.html
__ J
RE: Possi bl e Di scl osure of Confidenti al iCAD, Inc., PMI Appl ication Informati on
Dear Mr. Weinstein,
I am writiilg to bring to the Food and Drug Admi ni strati on's attention a
possi bl e serio LIS breach of confi denti al ity concerni ng the Company's premarket
approval appHcations on the part of an unknown indivi dual or individuals at the
agency. It was our i ntention to bri ng this matter to the attenti on of the
agency's Integrity Offi cer but it is our understandi ng that the positi on is vacant
at this ti me.
8, 2009, I was contacted the
for Fujifi l m l "1 edical Systems . , a company
.
oartnered i n regard to iCAD's seondLoo Di gital
Computer-aided Detecti on for Mammography device In our
discussi on, @related that Fuji had received a te ephone call earlier that
day from Gardi ner aivi dual representi ng himself as a reporer from
the New York Times. _noted that Mr. HarriS was under the
misimpression that "iCAD" was a Fuji device and was seeki ng Fuji's opinion
concerni ng very speCific questions on certai n documents related to the approval
of this "device" that had come into the possession of the New York Times
i ndi cated that Mr. Harri s further impl ieo that a member of Congress had
i ntervened i n this pmauct's revi e"" proces. and had pressured an PDA offi ci al to
support approval of , Duri ng the course of the conversation, it
became apparent to that Mr. Harris was referri ng to the aproval of
iCAD's SecondLool Fuji 's computed radiographic
mammography system . Accordi ngly, Mr. Harris was i nformed
that iCAD was a sepa en I 4 l"1 r. Harris i n tum i ndicated that he
woul d contact leAD regardi ng these documents and the SecondLook.
Appendix I: Relevant Documents
!
i `
On Friday, ' 2nuary 9, I personal l y spoke with Mr. Harris by phone with
Ms. Darl ene D=ptu! a- Hi clzs, our EVP and CFO, also present i n the room duri ng
the conve,sati on. In CUr discussion,Mr. Harri s stated that he was in receipt of
"i nternal FDi. :ocuinents" that were sent to hi m by "Scientific Officers of the
FDA, " Duri ng :rH = course of our conversation, Mr. Harris asked a number of
questi ons that dearl y refl ected a depth of detail and knowledge that onl y woul d
be known to either the Company or the FDA, and not generally avai l abl e to the
publ i c. I can assU,e you that the Company has not disclosed thi s sensitive
i nformati on to the New York Times, or to any other indi viduals or organizations
outside of its busi ness partners or attorneys, a nd only then with the appropriate
confidentiality rotections in place.
.
As you -? :wre, und?r 21 C. F, R, 814. 9, confidential iriformati on
submi tted to the agency as part of a premarket approval appli cation or a
supplement to that aJpl ication cannot be released by FDA with9ut the explicit
permissi on of c plp. sponsorv From the Mr. Harris, I am deeply
concerned that infc-rmtion concerning and potential l y other
Company subrn' s'on:, have been shared with the New York Times. Further,
aricles that ha'!e cor!temporaneously appeared i n other media outlets suggest
that the discl osure of this information may' have i'rvolved organizations beyond
the New York T;-e:. I have Ettached a sampl e of th,ese articles for your
reference.
We apDno;ci2t,;; y,Jur attention to this seri ous matter. Shoul d you requi re
any addition21 'nrcrrati on, pi e3se do not hesitate to contact me.
S.i ncerely,
. Ken Ferry
President and Ci >i ef icutive Officer
Cc:
Appendix I: Relevant Documents
1C cCl!11bOLLP
Kin, & Splding LLP
1 10Fr"lva,i A\'CUI. N.W.
Edwd M. Ic
April 1 6, 201 0
V HD DELIVERY
D. Jefery E. Shuren, Director
Center for Devices and Radiol ogical Health
U.S. Food and Administrtion
_!shire Avenue
Da Dr. Shuren:
[ a writing on behalf ofGE Healthcare, unit of Generl Electric Compay ("OE
Hcalthcare"), to express its disappointment in the Center for Dvices a Radiological Helth
("CDRH") for disclosing to te press confdential infor.tion in GE Healthcare's preret
noti fcalion C'5I 0k)") submission dated November 26, 208 and receive by CDR on
Decembr I , 20(8. On M-h 28, 2010, a Nel York Times article by Gardiner Haris entitle,
SLientists Say F.D.A. Ignored Radiation Wangs," revealed that "scors ofintemal agency
documentsrgading GE Healtbcare' s submission Wer provided to the New York Times. See
Appendix I. GE Healthc" is extremely concered abut this violation of confdentiality a
rsptflly reqests th.t you conduct a intera investigation into how this inforation was
leaked to the press. GE Healthcare als requests a meeting wit you to discuss steps you pla to
take going for"ar to ensure that breaches of confdentiality such a this one do not happen
again.
While the Food a'Drug Administration's ("FDA") general policy is to llow dislosure
orinfonnation, specific conditions onstrin =a-:FDA, ad Iherefore, CDR, may disclose te
eKistence a cntents of 51 O(k) submissions. None of these conditions wer present when
CDR disclosed information to Ihe Nell' York Tmes. CDRH wa not pennined to publicly
disclose either te existene or the contents ofGE Healthcare's 5 1 OC) submission,s in
disclosing ths inronation, CDRH breached the cnfidentiality ofGE Hclhc= s submission
in violation of bth federal regulations ad intemal agency policy.
\'l_IMANE14.1
Appendix I: Relevant Documents
April 1 6, 201 0
Page 2
!. Con ditions Under Which FA Can Disclos. the Existence of. SrOCk) Submi<ion
Under 21 C.F.R. 807.95(b), FDA cnnot publici) disclose the existence ofa 5 1 O(k)
submission for a device tha is not on the maket and whe the intent to market the device has
not ben Gisclod if three requirements ae met:
, the submin.r mut ruest in the subission that FDA hold a confdential commerial
infonnation t!e intent to market the device;
FDA agrees that te intent to market the device is confidential commerial information; a
the subminer must cerif a to th confidenliality ofth: inforation sd that nither he nr
anyone else h' disclosed the intent to market the device, that h will imdiately notif
FDA iehe discloses his intent to anyone who is not a employee, paid consultat, or mebr
ofa hired adverising or law fr, ad that he undersds that te submission offalse
inforation (0 the goverment is i llegal.
21 C.F.R. 807S5(b). If the requirements of section 807.9S(b) ae met, FDA cannot dislose
the existence orlhe 51 0(k) submi sion for 90 days ae FDA receives a complete S I OCk)
submision. See 21 C.F.R. 807.95(c)( I ). IrFDA rqut additiona information regarding the
sbmision the existence oflh. device wil not b disclosed Wltil 90 da)'s afe FA rceives the
complete submission. Preamble to Establishment Registrtion and Premarket Notifcation
Proedures, Final Rule, 42 Fed. Reg. 42520, 42524 (Aug 23, 1977) ("if the Comisioner
reuests additional information regading the device under 807.87(b), the existence of t
device wil! nol b disclosed until 90 days afer the agenc) s reeipt ofa cmplete premaket
notification submission.")
On November 26, 2008, OS Healthca submitte a 51 0(k) rueting CDRH cleaance
of a new CT colonogrphy screning indication for its C Clonography fl image salysis
sfware visuliztion device, a computerized toographic calonogaphy device for virtual
colonoscopies. In this Sr oCk) submission, GE Heltnca requested CDRH cleaance to perit
promolion of GE CT sca4'ing devices for C c10nograph), screening. CDR reived the
submission on Decmber 1 , 2008, and asigned it :~:
When GE Hethce submite its 5 1 0(1), C colonogaph)' scening w not bing
maketed. The us is stil! not on tle market today. OE He.lhcare did not disclose t existene
of ils 5 1 O(k) submission to ay individuals who were not employees, paid consultats. or
members of adverising or law lims hird under arngements safeguarding confidentiality. GE
Healthcare stil l 1ms nOI 'vesle il submission for CT col onogaph) srening. I n its
submission, GE Eeallhcare requeslod tht CDR hold a confidenlial commercial inforation
it intent to mae\ CT co]onography scening and made all certifcations rquired uner section
807.95(b). CDR did nOI object to GE Healthcare's request. Because GE Healthcar met all te
requirement of seion &07.95(b), CDR was nol peritted to reveal the existence of GE
Healthcare' s ; I O() submission for 90 days. OE Healthcare requeste this confidentiality
because it did not wat is comptitors to know that it wa s ing this clence, orcreate
Appendix I: Relevant Documents
April 16, 2010
Page 3
confsion in te marl:;t?lace a to the cleared indications for the curently marketed device.
Those goals are oow lost.
GE Health.are ha "sponded to numerou foral and informal requests for additional
reuired infortion fm CDRH since GE Healthcare submitted its 5 1 O(k) submission in
November 2008. CDR infored GE Healthcare in Decembr 2009 that it wil l b issuing
another request for eddilional inforation, which GE Healthcar is cu"ntly anticipating. In
asking for addition inforation, FDA is effectively stating that GE Healthcare's prmaet
submi ssion is not complete. According to section 807.95(c)(I) , requests for addi tional
inforation resel th 90 day period in which FDA is required to keep the existenc ofa 5 I O(k)
submission confdential b:cause the period does not begin until FDA receives a complete
premarket nOli lication submission. CDRH is not penitled to rve the exi stence of GE
Healthcare's stbm;ssi: until the submission is complete, so in revealing the existence ofOE
Healthcare's subission while still aking for additional information, CDRH has breach the
confidentiality reuirements of21 C.F.R. 807.95.
II. CooditiODs lnG., Which FDA Can Disclose the Contents of. SlO{k) Submision
Dat. or infora;ion submitted ",th or i ncorrated by reference in a submission a not
publicly eiselo,,,ie until the intent to market th device is no longer confdential. 21 C.f.R.
807.9(e); see aiSO Preable to Etabl ishment Reistration ad Prmaket Notification
Proedures, fins, Rui", 42 fed. Reg. at 42525 ("Once FDA ca dislose the fact that a
pmarket nOlification t>ists, me contents of the submission (other than inforation poteted
under 807.95(IJ} w! be available for public disclosure. "). FDA thus cannot disclose th
contents ofa S IO(k) submtssion untl it c dislose te fact that the submission exists. Cerain
inforation is ex!mpt !m dislosur even afer the intent to maket t device is revc such
a confdential cO!mercia inforation or safety and efetivenss data tht he not already
been disclosed to h . oubEc. See id; Trde Secr and Commercial or Finacial Inforation
Which Is ?rivilee: a Conice;ial, 21 C. F.R. 20.61(c) (2009). Once FDA makes a final
clasification dec'suw, snfety wd effectiveness inforation in the submission a available to th
public upon reue,t, uruess the device is Class III device. See 21 C.F.R. &07.95(e).
Becau CP'wa not authorized to disi 0' te existence ofGE Healthca' s S I O(k)
submission, it ws not amhor;o disclose the contents ofOE Heathce's submission either.
CDR has not Y me f clasification deision regaing C colonogaphy screening,
ad OE Heallhc2e stili nas not revealed it intent 10 maket t us, s inforation in t
submission is n' waH,'. for public disclosur and should not hve bee releae to th New
l'ork Times.
HI. Freom (f rclarmari"" Act Procedures for FA Disclolure of Inforation
Rei2ting "{ 51 t{h) Submissinns
\Vh FDA, is JruQri?P ildisclose the existence ad/or cntents of a S IOk) submission
to the gel PC;'''C, .. may ao so only in respons to a spifc witten ruest for dislosure
under the F,"om oiinfmm8.ion Act ("F01AU). See Policy on the Disclosur of Food a
Drg ACminisr,in :e-orcs. 2 i C.F.R. 20.20(c) (2009); Establishment Registrtion ad
Appendix I: Relevant Documents
April 1 6, 201 0
Page 4
Premaet Norii:stion Procedures, Final Rule, 42 Fed Reg. at 42524, 42525; FOD AND DRUG
ADMINISTR TlO". FD.k. STAFF MANUAL GUIDES 3297. 17 A (2007). We a uawar that any
such rquest wa receivd and processed th regard to OE Heal thcare's 5 1 O().
FOIA r""ueSiS fr information in 5 lOCk) submi ssions that met the requireents of
section s::(,fai i within 8 FOIA exemption ior reords containing trde secrets and
confdential co:rerciai information ("Exemptio 4"). Confdential commeia infonnation is
any '\aluable, nnpubj:c deta or information relating to busineses, commerce, trdeg
employment, p"cfitt, or fnaces." FDA STAfF MANUAL GUIDES 3297. 1 -70(4). Records
contning cnf(er.llg! commercial information a subject to preisclosure notification
(" PDN") ad ftst b wtheld or racted before releae. See id at 3297.1 70.
Under PuN procedures, fDA is supposd t make reasonable efors to notif a submitter
of FOIA ruet for information in th submitters 5 1 0(1) if te submitter has designated that
the submission be prctected a confidential commerial information, or if FDA ! ron to
bolieve that dislosure could r=nably b expected to cuse substantial competitive han to the
submitter. See Exec. Ore, No. 12,600 8(d), 52 Fed, Reg- 23781 (June 25. J 987); 21 C,F,R:
20.61(e)( I ); Con:ldent:e!!ty of Inforation, Final Rule, 59 Fe. Reg, 64287, 64289, 64290 (De.
14, 1 994); FDA STAFf I,'ANLAL GUIDE 3297.1 -8L. FDA prctice is to provide the submitter
with a copy oft!, reuest ad 5 J Ok) submission prior to release so tht the submitter c object
to dislosure b)' ldacling ;ny trde screts or confdential commeria inforation from te
submision. See 21 C.F.?. 9 10. 61 (e)(I); FDA STAFF MANUAL GUIDE 3297.2-7B(6)(A), T
submitter h fve &'s t cnecl to the reuesled disclosure- 21 C.F.R. 20.61 (e)(2). If FDA
decides to ciisclo,: Lne ,,,foraton despite a submitter's objections, it must infor the submitter
of why it did no' suswn his ibjetions. See 2 1 C.F.R. 20.61(e)(3). No such eforts wer mae
in this cas, athogl. it b OUf experience that FA always follows thee procedures.
T,ere 'S ,0 f:'';ahce ,hal Ihe New York Times me any FOlA requests for information
relating to GE Heatc", e's submission. Even if it had, it is unlikely tht the infontion
requested woule ;Ye b"n :'rshe s quickly bcaus FOIA requess generally ll e several
months to ye f:r !Di m rocess. See Eric P. Rcili ad Jaes D. Clements, A T for Ihe
Wary: How Cmnv!iI1cc WI/O FDA Medical Dt:ice Reglation Can Jeoprdize Palenl Rights,
46 IDEA 371 . 3'9 (2006). even ;fthe New York Tme had made a ForA rus, GE
Healthcare shout" hve been noified of the reuest and given 8 chance t object to the dilosue
bause the req""" involve confdential commercial infonnation. However. at no lime wa OE
Hethc8l infore.e' OfL1 reques or disclosre until it wa conlacte by New York Times
reporter G!iner He, on Mah 25. 2010, By not waiting for a FOIA request before
disclosing infom" lio" i 05 Healthcare' s submision ad not allowing GE Healthcare a chace
to Objet even if 'e ,,\'ew Yr. Tes ha me a fOIA rqul, CDR ated in violation of both
federal rguh.ic--5 :: inie 3:ncy procedures when disclosing information in GE
Hetca's 5 1 :'<} "i":1 isi'm.
wbile F:A ge:6:iiy fvors pubHc disclosure of infonnation, sp!ific conditions
constrin when ";" ;e. (.)o;"fo,", CDR, ca disclose information relating 10 51 O(k)
Appendix I: Relevant Documents
April 1 6, 201 0
Page 5
submissions. FDA may oniy disclose the existene ofa SlO(k) submision for a device that i s
not on the make: and where ihe i ntent t o mar;et the device i s not public if the submitter has not
designated the sumissbn a confdential or made the ppr ceri fcationsg or FDA disgrees
with the designa:ion. Olerise, FDA must wait 90 days to disclose the existence of the 51 O().
I f FDA ak te submiter f additional required information@ it cnot rveal te existence of
the 51 O) even zrr 90 days have elapse, because the confdential period dos not star until
FDA receives a cDmplele submission. FDA canot reveal the contents of a 5 1 0(k) until it can
disclose the exisenc of te submission, such a when the intent to market is no longer
confidentia or dter FDA !ae. a fnal non-Class II classification deision. Even when the
existence or co:o::nts of a submission ae disclosable, FDA will not dislose infonnation until it
has received a ";ecif,e ,.Tlten ruest and given a Submitter notic of the request and a chance 1
object ,to Lhe cisdcsu.
None of te w!ditions pnitting FDA ad CDR to reveal the existenc or contt of
GE Healthca, -e's 510(k) submission w present when CDR dislosd inforation to the Ne
York Times. EVfn i fLley were, GE Healtcare was not given a chance 10 objecl to (h rlease of
confdential inforonaticn in its submissions, in violation of federal regulations and interal
agency procedure.
Te con;,;.eta.;,y or 5 1 O(k) subisions is proteted by federal regulations tht rsulte
from extensive puo!ic discussion and comment In creating these regulations, FDA's goal w to
blac the need for L"iullest pssible goverment disclosu with the prprights of
pron in contici!nttal ':ort.mercisl inforation and the agency's need for fra intrl policy
deliberalio!ls. See 21 C.F.R 20.20(a). A breach in the confdentiality of 5 1 0(k) submissions
upnds the balan, e FDA h stcken beteen t ned of companies (0 pro teet inforation that
could cause competitive ha ad the need of the public for goverent transparncy. CDR's
releae of interal docu "ems such a emails and minutes of meeting also jeopaizs FDA's
slated goal of p.",eCIing 'te need for the agency to promote frinterl policy delibrtions
and to pursue itr egda'cr Betivities without disption 21 C.F.R. 20,20(a). By disloing
information in G3 H,'ti.care's submission in violation of these regUlations, CDR ha
disr!ted ,-is fn-n, bs:!,e of interests and sacrifced pressing private ad goverental
needs in the na of ..n'/arrate public disclosure.
You prcmpl ".tf: [0 :'11s maer would b greatly appreciated. I will be contting
your office 10 s:;dule metng 10 discuss this matter.
Sincely
Edwd M. Basile
cc: De Me' :0r, CkfQua!it)' Ofcer, GE Healthcare
Paticia Aaeding, C1iefReguiatory Counsel, GE Healtcare
Appendix I: Relevant Documents
DEPARTMENT OF HEALTH & HUMAN SERVICES
The Honorable Charles E. Grassley
Ranking Member
Committee on the Judiciary
United States Senate
Washington, DC 20515
Dear Senator Grassley:
OFFICE OF THE SECRETARY
Assistant Secretary for Legislation
Washington. DC 20201
March 13,2013
Thank you for your letter of July 24,2012, concerning the unauthorized disclosure of
Food and Drug Administration (FDA) documents through a publicly accessible server
operated by Quality Associates, Inc. (QAI). FDA and Department of Health and Human
Services (Department) staff provided your staff, and staff of the House Committee on
Oversight and Government Reform, a briefing on this matter on September 14,2012. For
purposes of this written response, Dr. Hamburg asked that I respond on her behalf
because the business arrangement with QAI involved the Department of Health and
Human Services (Department).
As we have previously advised, both the Department and FDA take seriously the
unauthorized disclosure of sensitive personal information, confidential commercial
information, and trade secrets entrusted to us. The Department is required to investigate
security breaches in order to minimize the risk to the Department and individuals
affected, and conducted such an inquiry in this case. The results of our internal review
are included in the attached written responses to your specific questions. We apologize
for the delay in providing you this follow-up written response, and appreciate your
patience in this regard.
It is important to note that the FDA and the Department of Health and Human Services
Program Support Center (PSC), which handled the Government Printing Office (GPO)
contracting vehicle for the QAI task order, went to great lengths in attempting to protect
the material in question from improper disclosure. At all times while the data was in the
custody of the FDA and the PSC, it was securely maintained on an encrypted, 12-digit
passcode-protected external hard drive. Data stored on the hard drive included, among
other things, confidential commercial information, which the FDA is obligated to protect
under federal law .
FDA requested the PSC's assistance in arranging for the conversion of the securely
stored data to readable and printable format. FDA indicated to the PSC that the materials
Appendix I: Relevant Documents
The Honorable Charles E. Grassley
Page Two
were highly sensitive and requested that the copying job be assigned a contractor that had
prior experience with large copying jobs of sensitive and confidential documents. The
PSC designated QAI under a Simplified Purchase Agreement (SPA), a streamlined
printing procurement vehicle used by the GPO's customer agencies in the Executive
Branch.
The PSC advised QAI that the documents were sensitive and that access to them should
be limited. The PSC further requested that QAI delete all files on its computers after
completing the job, and shred any printed documents in its possession. Regrettably,
despite these instructions, QAI's unauthorized use of an unsecure website caused QAI to
lose control of the confidential material. Although the PSC reviewed this matter with the
GPO's Contracting Officer, unfortunately, the GPO's formal complaint process is limited
to reports of poor printing quality, and is not designed to address security breaches.
Again, we share your concern about the data breach that occurred here. Any
unauthorized use, disclosure, or loss of confidential information, such as the breach that
occurred here, has the potential to undermine the public's trust and confidence in the
Department's ability to properly protect such material, a matter we take quite seriously.
We would be happy to answer any further questions you may have.
Sincerely,
P ~ ; ( 1 . T
Jim R. Esquea
Assistant Secretary for Legislation
Enclosure
Appendix I: Relevant Documents
RESPONSES TO SENATOR GRASSLEY'S QUESTIONS REGARDING
QUALITY ASSOCIATES, INC. WORK ORDER 69308
1. Please provide and describe all communications to Quality Associates regarding the
file converting contract, DHHS\FDA work order 69308.
The first direct contact between personnel of the Food and Drug Administration (FDA or
Agency) and Quality Associates, Inc. (QAI) regarding the work perfonned under this
contract occurred on July 13,2012, when FDA learned from a reporter that confidential
Agency records appeared to have been released to the public.
In late April, 2012, individuals in FDA's Office of Infonnation Management contacted
the Program Support Center (PSC) of the Department of Health and Human Services
(HHS), to request its assistance in arranging for certain FDA records to be organized and
produced, in portable document fonnat (PDFs), and printed. FDA personnel hand-
delivered these records to the PSC on April 30, 2012, on an encrypted, 12-digit passcode-
protected external hard drive. FDA requested that PSC utilize a contractor with proven
experience handling sensitive infonnation, and with whom PSC had a strong
confidentiality agreement. The PSC later arranged for the data to be delivered to QAI via
the same secure hard drive. For added security, FDA separately conveyed the 12-digit
passcode to the PSC by telephone.
The PSC initially engaged a different finn, Ideal Scanners and Systems Inc. (Ideal), to
organize and produce material from files stored on the FDA's encrypted hard drive in
PDFs. On May I, 2012, Ideal personnel picked up the hard drive and took it to Ideal's
facilities. However, after Ideal obtained the 12-digit passcode from the PSC, Ideal
detennined that it lacked the technical capability to convert all of the hard drive data to
PDFs. The next day, Ideal contacted the PSC Printing Specialist, who was on-site at QAI
at the time for unrelated reasons. After the Printing Specialist and QAI conferred by
phone with Ideal, QAI indicated that it could meet the technical and expedited time
requirements for the job.
The FDA had requested that the job be completed within 72 hours, by Friday, May 4,
2012. The Printing Specialist verbally infonned QAI that this was a "sensitive job"
involving litigation and was to be treated as such, including by ensuring the files were
handled by as few staff as possible and removed from computers when the job had been
completed. QAI sent a courier specifically cleared to handle sensitive data to pick up the
hard drive from Ideal. Moreover, Ideal gave QAI the passcode verbally.
The PSC did not authorize QAI to load the files on a publicly accessible file transfer
protocol (FTP) site. Although QAI shared with the PSC a link to its FTP site with the
first set ofPDFs it generated, FTP sites may be shielded from public view through at
least two techniques: (1) password protection and (2) "locking down." Thus, QAI's
reference to its use of an FTP site failed to alert the PSC that documents would be
publicly available. Indeed, neither the PSC nor FDA were aware that the material was
available on a publicly accessible network until a reporter for the New York Times
infonned the FDA of this fact on July 13,2012.
Appendix I: Relevant Documents
QAI completed the job on May 9,2012. The PSC documented the work done by QAI,
which included organizing, bates-stamping, and converting data to PDFs, as part of Work
Order 69308 on May 23,2012.
Unfortunately, the GPO's required Work Order forms do not reflect the variety of
confidential material frequently handled by Executive Branch agencies, including
material as to which Congress has imposed specific statutory protections. The forms
provide only three document category options: a) Classified; b) SBU (sensitive but
unclassified); and c) PII (personally identifiable information). Other options for
identifying protected information, such as confidential commercial information, are not
available on GPO's Work Order form.
Although the FDA hard drive in fact contained PII (one ofthe designated options on the
form), the Work Order that the PSC later submitted to document the job order
inadvertently indicated that the material did not contain PII. Notably, however, this
erroneous documentation occurred after QAI had completed its work, and, therefore,
could not have contributed to QAI's unauthorized disclosure of FDA's sensitive and
confidential data.
2. Prior to May 23, 2012, did FDA represent to Quality Associates that the files
submittedfor conversion contained no information that was classified, SBU, or PIl?
Please describe all communications with Quality Associates regarding the nature of
the documents to be converted and provide all records relating to those
communications.
As noted above, FDA had no direct contact with QAI prior to the completion ofQAI's
work in this matter. The PSC verbally informed QAI on May 2,2012, the same day work
on the job commenced, that this was a "sensitive job" involving litigation and was to be
treated as such, including by ensuring the files were handled by as few staff as possible
and removed from computers when the job had been completed. The fact the data was
delivered on an encrypted, 12-digit passcode-protected external hard drive reinforced the
extra security precautions that the PSC expected QAI to take. The PSC's Printing
Specialist also asked QAI to shred any documents they had in their possession derived
from the work.
3. Why was Quality Associates allowed to begin work without an authorizing work
order? Was the work completed on a rush basis, and ifso why?
The PSC and the vendor were attempting to accommodate the FDA's request for
expedited delivery; i.e., to have the job completed and delivered to FDA within 72 hours.
4. Please explain the timeline as to when Quality Associates actually performed
services for the federal government. More specifically, please clarifY how Quality
Associates claims that the files were uploaded on May 3, archived on May 9, the
order was placed on May 21, and the work order was approved May 23.
2
Appendix I: Relevant Documents
QAI received the job from PSC on May 2,2012, and completed it on May 9, 2012. The
final print order was generated afterward. While the initial request was for approximately
10,000 files of various sizes in approximately 1,000 folders on a hard drive to be
converted to PDFs for purposes of printing, the number of PDF pages requested to be
converted, and the formatting of the job, changed several times during the process,
thereby delaying delivery on the initially requested date of May 4,2012.
5. Who was responsible for initiating the work order eventually received by Quality
Associates? Please provide the originating document(s}.
The Printing Specialist for the PSC was responsible for initiating the print order. The
originating document is Work Order 69308 (attached to your letter).
6. Were there any additional employees, either within FDA, the Government Printing
Office (GPO), or any other federal agency responsible for passing along the details
of the Quality Associates work order? Please provide the information about the
documents related to all of the steps required from the originating document until
the purchase agreement is considered complete.
a. No additional employees within FDA, or any other executive branch agency, or
GPO, were responsible for passing along details of the QAI work order.
b. A completed HHS-26 Form is the originating document for a print order. If an
HHS-26 is not accessible, a customer may email its job requirements and method
of payment to initiate work on the part of the Program Support Center. On May
2, 2012, the Program Support Center received the final set of requirements from
FDA, including the funding information.
c. We note that the work order and invoices were included with your letter.
Attached hereto are the terms and conditions and instructions for completing the
4044.
7. Who was responsiblefor preparing the "Simplified Purchase Agreement Work
Order Form 4044" for Quality Associates' DHHSIFDA work order no. 69308?
Where did that person obtain the information contained within the document?
a. For Work Order 69308, the PSC Printing Specialist was responsible for filling
out the Simplified Purchase Agreement Work Order Form 4044.
b. FDA provided information to PSC regarding the nature of the documents.
Although this information was not fully reflected on the completed form, the
form was not prepared until after the work was done. Nonetheless, PSC did
convey the sensitive nature of the information to QAI orally, before it undertook
the work.
8. Does the FDA still maintain that the documents provided to Quality Associates
contain no information that is classified, SBU, or defined as PI! under the Privacy
Act?
3
Appendix I: Relevant Documents
The FDA and HHS have never maintained that the hard drive contained no personally
identifiable information. The absence of such a notation on the later-completed work
order was the result of a clerical error at the PSC.
9. What litigation was this document conversion being prepared for? Were the
documents being prepared for production or merely for review in order to determine
what would and would not be produced?
At the time QAI was engaged to convert the FDA data into a readily printable form,
concerns related to the computer monitoring of certain current and former FDA personnel
were already the subject of Congressional and Office of the Special Counsel (OSC)
investigations, as well as litigation. The printing was principally intended to enable
review of these records to facilitate understanding facts thought to be potentially relevant
to these matters, and not for production in response to a specific request.
10. Quality Associates asserts that the original files were initially supplied on physical
media to another contractor. What is the name of the other contractor?
The original contractor requested to perform this work was Ideal Scanners and Systems
Inc. Ideal was unable to perform the work.
11. How many files were contained on the physical media?
The PSC did not open the files on the media provided; however it is estimated to be
10,000 files per emailed requirements.
12. What was the total number of pages provided from Quality Associates to FDA
following the conversion?
The total number of pages provided from QAI following the conversion to PDF was
83,187. Three copies were printed and delivered to FDA.
4
Appendix I: Relevant Documents
QUALITY
ASSOCIATES
,!Ii< x)RPORATED
, '
United States Senate
Committee on the Judiciary
Attn: Senator Grassley
Washington, DC 20510-6275
RE: Letter received on July 16
th
(attached)
July 17,2012
Quality Associates, Inc. is extremely concerned by your letter and would like to address your
questions. We have also contacted your staff in the interest of providing information and
clearing any misunderstandings that we have done anything other than follow our Clients
directions.
Please see the following answers to your questions:
1) With how many government agencies does Quality Associates have contracts?
Please provide the total dollar amount for each agency.
Response - QAI has hundreds of government Clients and the dollar values for each range from
hundreds of dollars (for product purchases) to millions of dollars for multi-year support
contracts.
2) Which ofthese other agencies' internal information, if any, was accessible through
the Internet prior to Friday afternoon?
Response - The FTP site is used to make available conversion tools (script files, custom coding,
etc.) and DLL files for our engineers to download and implement at client sites. Occasionally,
we have Clients that request files and, with their approval, we use the FTP site for the transfer.
3) Why were these internal documents publicly available and searchable on search
engines, such as Google?
Response - The files were put on our FTP site at the direction of our Client. During the time that
they were there the files were "crawled" by the Google engines.
4) What services, specifically, do you provide for each of these agencies?
Response - Quality Associates Inc. (QAI), a Maryland based Small Business, was established in
1986 as a Quality Assurance (QA) Good Laboratory Practice (GLP) consulting company to
1
QualityAssociateslnc.com I 8161 Maple lawn Blvd. I I Fulton, MD 20759 I Phone I Fax
Appendix I: Relevant Documents
QUALITY
ASSOCIATES
IN(. 'ORPORATED
proy ide services to the pharmaceutical, pesticide, and other appropriate chemical and biotech
industries. In the late 1990's, QAI started to focus more on the Federal marketplace, primarily
with the regulatory/research agency's who required day-to-day business solutions for turning
paper-based information into usable electronic data. In recent years, QAI has expanded its client
relationships to include educational, healthcare and banking customers and is now providing full
document/content management solutions based on the Microsoft SharePoint ECM platform.
5) Has Quality Associates ever discovered a similar leak as the one identified in The
New York Times article? If yes, please provide a detailed explanation of each
instance.
Response - Never.
6) How long were the FDA documents publicly available on Quality Associates Internet
site?
Response - The files were first uploaded to the site, at the direction of our Client, late in the
evening on May 3
rd
There were several iterations of file revision and reloading to help our
Client with their printing of the files. The last day that we worked with our Client and these files
was on May 9
th
. Our records show that the files were archived on May 9
th
.
7) What steps have you taken to ensure that such internal information is not
inappropriately available online in the future?
Response - We have removed the FTP site and will handle all future receipt and delivery of
Client information, regardless of Client direction, via physical pick-up/delivery and/or
secure/encrypted transfer.
Paul Swidersky
President, CEO
2
QualityAssociateslnc.com I 8161 Maple Lawn Blvd, I I Fulton, MD 20759 I Phone I Fax
Appendix I: Relevant Documents
.::Tj\lb
Simplified Purchase Agreement
Work Order Fonn 4044
QUOTES DUIi BY
372-628
1IT1.E
LITTIGATION FILE ORGINAZATION
CONl1tAC1OR
Quallty AssOciates Inc
BlWNGADDRESS CODE AGENCY LOCATION COR (ALCI
PURCHASE ORDER 1'0.
96645
t
4164-01 75060099 legggg,1fIrr.
NAIliE AS IT APPEARS ON
c
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...
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o
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01:
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PHON. NO. OF CARDHOLDER EMAL OF PURCHASE CARDHOLDER
TREASWlY ACCOUNT SYII8Ot. (TAil
l-
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LlNI! OF ACCOUN11NG REFERENCE NUMBER (Il'1O WII Appear an IPAC EnteNd)
2000061
PROOFS
o Cont.nt
o PIlar to ProductIon .......... __ _
OFTEXTINK lEXT COAliNG TYPE
to JAMES HELTON. MIlO FIIII_ ..... P ....... Bldll. Raml , RockvIIe.IIID 20117.
forlht ParNa .... BuIlding .... :00 I",'" 12:00 pm -1:00 pm 10 4:00 pm. nat be"'- It 1 ..... lIIIdoc .....
1 __ to M _ to: U.S. CJoI/Im_ PllnllIII 0IIIce. OllIe. of .... ConIphIIw.I'IOP FMcs, WuIIlngton. DC _,
to 2OU Include _run end __ Oft .. be .. to _ .. .,...,...r,.,....,
SUPT. DOCS. NDTFIED SUPT. DOCS.
DVM /ilNo
CONTRAClOR TOTAL
$4.000.00
DOCS. COST
CONTACT:
AUlHORIZINIJ SIGNATURE (must be on fII. willi Gpo)
TlfISFOIUI
lEXTPAGES
o
PRINT
DOnI SldeOIlead to 0 IIud to
Only Head Fool
D SuppIImentaI __
PDF
o
Appendix I: Relevant Documents
Ipl'ClVldlHl To:
Quality Aaoctltel. Inc.
8181 lIaple Lawn Blvd,
Maple Lawn. MD 20759
F x
Tel:
PI'Inting 8peel,lIIt. Pub IIgmt Bl'IIIICh
DIY of Support 8ervk:el
Program Support Center
5800 FllhenI Lane. Room
Rockville. MD 20857
PSC Contact:
project:
Agenr:;J:
PSc Conlact Phone:
Email:
Preper.d By Name:
Payment ta""S are net 30 days.
C_lon8eMcH
PSC DIY of Support Servicel
301-
Appendix I: Relevant Documents
Laptop Name - DRL0 0 9 8 6 8 6
Spector Client : installed and active since 4 /22/10
SUBJECT : Robert C. Smith ( RCS )
Medical Officer
W06 6 RM0 3 1 9G HFZ-470
CDRH - ODE/DRARD
Search Terms :
Colonography - SUBJECT feels the FDA is not handling this issue well .
Allegations :
Sending proprietary documents and information out of the FDA. Some
documents are may have the letter "K" followed by a string of six ( 6 )
numbers . Check to see i f SUBJECT i s sending these outside the FDA.
Probably using Gmail to send out .
SUBJECT sent proprietary documents to pres s , possibly NY Times ( Gartner
Harris - sp? ) - ( Gardiner Harris - Corrected) for article alledging the
FDA was mis-handling the Colonography topic .
His superiors believe HE is " ghost writing" his subordinates FDA reports .
Check all possible avenues for possible occurances .
SUBJECT ' S subordinates or co-horts :
Nancy
Lakshmi Vishnuvaj j ala
DRL0 0 9 1 4 9 4
DRL0 1 02315
DRL0 1 0 1 0 4 6 DRL5125 4 4 9
DRL0 1 0 1 6 0 0
DRL5 1 1 4 9 24
DRL5125617 DRL0 0 9 6322
Check all for possible POP3 or enternal , non-FDA email conversations ,
either via Websense, Encase, Mandiant, or Spector .
l0/lI
0001854 Appendix I: Relevant Documents
Actors List:
PrimalYActors
1. Robert C. Smith Medical Ofcer, CPR, ODE/DRARD
W066, 10903 New Hampshire Ave, Silver Spring, M
2. Paul T Hady (also referred to as "PJ") - Regulator Review Oftlcer, CDR,
OIVD
W066,_ 1 0903 New Hampshire Ave, Silver Spring, M
3. Julian J. Nicholas - Fonner CDR Physician
Summary - The above listed actors appear to be the point men. All communications
amongst all the actors filter through one or all of these three primay actors. These actors
appear to perfOlm the majority of any review, editing, compilaton, production or
distribuion of verbiage, documentation and info1llation. Actors 1 and 3 appear to have
the greatest involvement with media outlets and exterl orgazations.
Secondar Actors
.OlOI18!. CDR, OPB/PRARO
470, [0903 New Hampshire Ave, Silver Spring, MP
5.
6.
Visiting Scientist, CDR, OSELlDlM
0903 New Hampshire Ave, Silver Spring, M
Biomedical Engineer, CDR, ODE/POS/IB
10903 New Hampshire Ave, Silver Spring, MP
7. Nancy Wersto Biologist, CDR, ODE/DRD
W066, _, 10903 New Hampshire Ave, Silver Spring, MD
8. Lakshmi Vishnuvajjala - SUPV. Mathematical Statistician, CPR,
OSB/PBSIPB
W066, _ - 550, 10903 New Hampshire Ave, Silver Spring, MP
9. PJo;i<+ CPR, OPE/PRR
470, 10903 New Hampshire Ave, Silver Spring, MP
Suary - The secondary actors listed above are in constant communication amongst
themselves and the primary actors va FPA email, Yahoo Mail and Gmail.
Communications involve review, editing, compilation, production Or distibution of
verbiage, documentation and informaton pertaining to medical reviews, CUlet
investigations, claims against HHSIPA, release of infomlation to the press and extemal
organizations.
Ancillar Actors
10. Ned Feder Staff Scientist ! Writer
Oversight)
POGO (Project On Govemment
11ol\
It In
: 7
0001023
j v
Appendix I: Relevant Documents
1 1 00 G Steet, N, Suite. Washington, D.C
1 1 . - Associate of Ned Feder
Nuclear Engineering, Texas A&M University
12. Jack Mitchell - United States Senate, Special Committee on Agig
G31 Dirksen or 628 Ha Senate Office Buildings, Washington, D.C.
1 3. Joan Kleinman District Director, Congressma Chris Van Hollen (D-Md)
Ofce of Representative, 51 Monroe Street #507, Rockville, Md.
14. Congressma Clis Van Hollen (D-Md)
House of Representatives
1707 Longorth RO.K, Washngton, D.C.
Distict Ofice - 51 Monroe Street #507, Rookille, Md.
Summary - The acillary actors above ae actively participating with primary and
secondary actors with regard to complaints ad claims filed against HHSff'OA
referencing FDA review / approval process, discrimination and hostility within the
workplace. The above actors (with the excetion of Congressman Chris Van Hollen and
directly) have received a substantial number of documents primarily
fom Actors 1 and 3. There has also been numerous comunications wit many of the
secondary actors either directly or though the primary actors. References to one or more
of the above ancillary actors providing a condlit to release information to the press has
been identified.
Media Outlet Actors
15. Gadiner Harris - Reporter, New York Times
16. Mathew Perrone - Reporter, Associated Press
17. Alya Kha- Reporter, Inside Washington Publishers news organization
18. Joe Bergantino - Reporter, RCN Cable Washington based Direct Cable provider
1 9. Rochelle ( last name unkown) Assooiate of Joe Bergantino
20. Lainey Moseley-Jouralist, Unknown Philadelphia news organization - looking
for a "Bigger Story" on CT scans, patient safety and FDA recommendations
21 . Joe (last name unown) - Doclentaries, Frontline PBS (Public Broadcasting
Service)
Sununary - The media outlet actors listed above have actively and recently
communicated primarily wit Actor 1 . Actor 1 has been in constat contact with Actors
15, 16, 17, & 1 8 via email, phone COllUl1unications adlor in-person meetings regarding
"issues with in the FDA". Actor 20 was refcned to Actor 1 hy Actor 3. Aotor 21 has
been referenced to Actor 1 by Actor 2.
0001024
Appendix I: Relevant Documents
Scott A, Vate
U.S. Departent of HeaLo a"ld Hua Services
Ofice of Inspetor General
Ofce of Investigations
Special Investigations Unit
330 Independence Avenue, S.W.
Washington, DC 20201
R: GE Healtbcare Complaint
Dear ASAIC Vantease:
'l ' ' ""Y
J ~Y + ? 4 &
Foo ad D Adnisaton
Ofce oferal
&
n . ,,,',
Oe Chuh
Rob'le M
May 14, 2010
the Ofce of Ita ls wagiven a copy of a complaint fom King and Spading, a law
fr esenting GE Heatcae. Ts complaint alleges disclosure of condental informaton by
unown individuas at te FDA's Center for Devcs ad Raologcal Healt (CDR.
A these allegations ae ver serous and t avoid any appearace of impropriety, I respetfully request that
HS/OIG/SIU inveigat GE Heatcae's al egaton4 Becuse te ora is entirely independent of te
programs and ofcials being investigat, any potental allegatons of confict of interest by any Pa, Or
membrs of congress would be eliminate. Please contact me at (240l@ifyou wsh t discuss ts
matter.
Encl osuC
Cc:
Case File
ChrOIl
Sincerely,
-
Mark S. McCormck
Special Agent in Charge
Appendix I: Relevant Documents
Food and Drug Administration
Ofce of Iteral -iTa is
Cae Initiaion and Fact Sheet
Case Numbr: 201 0-0LA-9iO-073 Case Title: GE Hea\thcare
Cae Type: Unauthorized Disclosure of Iformation Case Assigment:
COMLAIT:
Date Received: 4i23ilO Person Receiving Allegation: S.A.C McCorack
Complaint'received by: Telephone: Letter: Oer: X (email)
Nae of Complainant: King and Spaulding, LLP
Address: 1 700 @ WC 20006
Telephone NUlmler:
Allegaton ado Issues: GE Healthcare alleges unauthorized disclosure ofinfonnation by
uown FDACDR employees, Ts allegation is being referred to HS/OIG/Sr to remove
any potential allegations of impartiality,
SUBJCT(S):
Grade:
Title:
Component:
Regon:
Address:
Telephone Numer:
Other Agency Invol\ement:
OlG Notifcaton: Telephone:
Date Notifed: 5'/1 7/ 1 D
Peron Notified:
5<'- Vcfo 4 S<
COlENS:
SAle .., . + ~
--
Memorandum:
Date: 5 / /-/0
Fa:
Appendix I: Relevant Documents
DEPARTMElT OF HEALTH ANO HMAN SERVICES Oce ofln.peetor Genera
Ofice of Investigations
.Si!estig.i!s BT8
Washington, DC 20024
M. Mark McConnack,
Special Agent in Charge
U.S. Deparent of Helth and Human Services
Food and Drug Administrtion
Ofce of Criminal Investigations
Ofce of Ite Af a
I Chuch Stret, @
Rockville. M 20850
R: Cae Name: Unauthorzed Disclosure of Inforaton
O File #: H-IO-<-OI41-3
Dea SAC McConack:
JUL 2 6 2012
I witg to clarf our May 1 8, 2010, letto you regning your rferral (OIA File #: 2010-
OIA-970-073). First, the Ofce of Inspector General (OIO) does not delermine the legality of
disclosures of condenta govemet-held informaton. Itead, an OIG conducts
investigaOis and refers maters to the Deparent of Justce when the orG determines there a
" onable gounds to believe" tere ha been a violation of Federl criminal law. (lG Act,
4(d)). O 20lO lelter should not be read to refec a detmrnation by orG about te rh of
Federal criminal law. Again, t deterination rests with the Depament of Justice and te
cur. OlGs May 2010 decision to tae no fer aton on youreferral was base on ou
assessment of the evidence available at that time under the standard set forth in the IG Act
If you have any
free to contact me
Enclosure
additional information regarding tills matter,
p
Jease feel
Sincerely,
~
Elton Malone
Specinl Agent in Charge
Specia Investgations Branch
Pl
Appendix I: Relevant Documents
M. Mark McConnack,
Special Agent in Charge
MAY 1 8 2010
U.S. Depaent of Health and Hu Serices
Food ad Drg Administtion
Ofce of Criminal Investigatons
Ofce ofIntemal Af airs
l Chillch S1
Rockville, M 20850
R: Cae Name: Unauthorized Disclosure of Infonnation
01 File #: HI00001413
SAC McConack:
Ofce of Ipectr General
Ofce oflnvestigations
Special Invetigations Branch
Washington, D.C. 20201
The U.S. Dearent ofHeaJth and Huma Services (HHS), Ofce ofInspector General (OIG), Ofce
oflnvestigations (01), Special Investgatons Branch (SIB), is i receipt of yo ilreferral (OIA File #:
20 1 0-OIA-970-073). At this time, based on the infonnation provided, OIG/Ol/SI will b taking no
acton. Te referral lacks any evidence of criminal conduct on the par of any HHS employee.
Additionally, 5 U.S.C. 1213, identfies that disclosus, such as the ones alleged, when they relate to
maters of public safety may be made to the media ad Congess as long as the material released is not
speifcally prohibited by law and prteced by Executive Orde or National Seurity Classifiction.
The OIG is appreciatve of yo ill support in it overal mission. Thank you for contacting te oro on this
me at
any.questions, or need any additional infonnaton, please fel fee t contact
Scott A. Vatese
Assist Special Agent in Charge
Specia Investigaions Branch
Appendix I: Relevant Documents
McKee, Ruth E
From:
Sent:
To:
Mary, Kenneth L (01
Friday, June 1 0, 201 1 1 :37 PM
McKee_ Ruth E
'ubJect: Complaint RE: Hardy et.al.
A:achment: H1 00024830016a2449 20101 1 1 5 Closing Memo to CDRH.pdt, H1 00024830015a2449 20101 1 05
Declination Letter from DOJ PI N. pdf
Ruth,
The ref!rral you made to our ofice in March of this year regarding the .wav files was subsumed into case
H100002483 since it pertained to the same category of conduct.
Attached are previous documents our office transmitted to your office regarding that case. As in that instanceg we
are deferring to FDA for any appropriate administrative action.
If you need a more official letter from us, please let me know.
Sincerely,
Kenneth Mart, Inspec/or
Special investigations Branch
Ofce ofInspector Genera, Offce 'ofInvestigations
U.S. Department ofHealth & Hllman Services
330 Independence Ave., S r@
Cohen Bldg.,
This ;maiI may contain l'ellsitive /aw enforcement muorpril'ileged iJjorltion. Ifyou are not 'le illtended reCipient (or
IImle received tilis E-mail in error) please noti Ihe sender immediatel)' and destroy this E-maiL Any unauthorized copying.
di
lo
s
.I!.or ii slrbu.tio
r
!.9/lie , eria!l!.!J!lis E-mq}s sl !lE(
lorbidlle':
&&+
From: Mehring, Davi d 5 (OlGjOl)
Sent: Frida, June 10, 2011 10:27 AM
To: Mart, Kenneth L (OIGjOI)
Subjec: Complaint from Ruth McKee
Kent
Here's the a dditional complaint sent to us by Ruth McKee after we closed our investigation (H10002483), and my
email response. I've also i ncluded DOl/PIN'S declination letter, and our cse closing memo to CDRH.
Let me know if I can provide any further info, or assist with the response to CDRH.
Dave
David Mehring, Special Agent
U.S. Department of Health and Human Services
Office of Inspector General
Special Investigations Branch
1/3 1 /201 2
P I
Appendix I: Relevant Documents
DEPARTMENT OF HEALTH & HUMAN SERVICES
. ... . ,.
Qjiel R. Levinson, Inspector General
U.sDepartment of Health and Human serices
Offce ofInspector General
Washington, DC 20201
Re: Potential Unlawfl Wiretapping By FDA Employee
Dear Mr. Levinson:
Food and Drug Administration
1 0903 New Hapshre Avenue
Silver Spring, MD 20993-0002
We have obtained evidence that at least two FDA employees appear to have engaged in
widespread recording of telehone calls and meetings regarding FDA business without the
consent of all other parties. We are concered that these actions violated state andor feea
criminal laws. I have enclosed with this letter a draf summary of some of the recordings we
have obtained, and I a sending all the recordings to you via your secw:e IT portal. Please
review this infor1ation to determine whether the Ofice of Inspector General (OG) will open an
investigation.
In the course of network monitoring, we discovered 96 .wav fe containing recordings of
conversations the employees had with other FDA employees and with representatives of
companies with matter pending before FDA. These . wav fles were located on a thumb drive
connected to an FDA computer in "tmallocated spae" indicating they had been "deleted" but not
yet overwritten. The recordings themselves suggest that they were made by two diferent
employees, and the recordings also suggest that many of the participants were not aware tat
they were being recorded. The subject matters of these recorded calls and meetings include the
review of pending medical device submissions, FDA persOimel matters, and efforts of the
employees to use the press and Congress to force the removal of specified FDA managers.
These recordings include non-public information, some of which appear to constitute
conidential commercial information. For instance, Files 1 6 and 1 7 are recordings of
conversations with a manufacturer regarding a device submission. Although the files we have
obtained do not specify the dates or times of the calls themsel ves, we expect, based on the
context and subject matter of the recordings, that the calls generally took place between 2008 and
201 0.
.
The employees seem to have been in several different physical locations, all of which were likely
in the State of Maryland, when they made the recordings. In particular, the recordings suggest
that they were variously recording te calls and meetings from their FDA ofces (in White Oa,
Maryland or Rockville, Maryland), and from coffee shops near the FDA ofices.
Pl
Appendix I: Relevant Documents
There is no FDA policy or practice that supports the unauthorized taping of phone calls or
meetings by employees, or the use of FDA equipment or resources for such pwposes. 1
Moreover, the creation and storage of these recordings might run afoul of the requirements
relating to the secure storage and destuction of sensitive information and prohibitions against
the concealment of such information for personal use; these requirements are contained in the
Department of Health and Human Services Rules of Behavior For Use of Technology Resources
and Information, which all employees must read and sign.
More signifcantly, these nonconsensual recordings potentially violate state or federal criminal
wiretapping laws. For example, Maryland law prohibits the interception of oral or electronic
communicatons unless ao]thecctesto the communication have given rior consent to the
intercepton . . ,,2 Violations are felonies subject to imprisonment and fnes. Federal law
appears to require the consent of only one party to the interception of a phone call,4 but the
unauthorized taping of calls by federal employees involving confidential information may
constitute prohibited conduct.
If you have any questions, or if you need any additional inforation, please let me know.
Enclosure
Sincerly,
Jefey Shuren, M.D., J.D.
Director
Center for Devices and
Radiological Health
FDA regulations generlly allow the recording of public administtive proceedings, with advance notifcation to
the agency. See21 C.F.R. 1 0.204. None of the caUs at issue here appear to constitute public administative
groceedings.
Md. COURTS & JDICIAL PROCEEDINGS Code Ann. 10-402(c)(3) (emphasis added). Other exceplions
apply, which do not appear to be relevant here.
, Id 1O-402(b).
See 1 8 U.S.C. 251 1 .
P2
Appendix I: Relevant Documents
" ""
/:-'
DEPARTMENT OF HEALTH & HUMAN SERVICES
.
..
WI
Office of the General Counsel
Offce of the 'Chief Counsel
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
TO: Walter Harris, Chief Operating Ofcer
Eric Perakslis, Chief Infonnation Ofcer
FROM: Elizabeth H. Dickinson, Chief Counsel .
Applies to all individuals (including, but not limited to current and former civilian
govemment employees, contractors, local or foreign govemment exchange program
participants, Commissioned Corps personnel, guest researchers, visiting scientists,
fellows and intems), provided access to HHSIFDA IT systems and resources;
Does not apply to computer incident response monitoring of systems relating to national
secUlity or the Federal Infonnation Security Management Act of ZZ (FISMA) that
perfonn general system and network monitOling, or examinations of computers for
mal ware;
Does not apply to any review and analysis requested or consented to by the individual(s)
being monitored;
Does not apply to retrospective searches for documents in response to valid infomlation
requests in the context ofiitigation, Congressional oversight, Freedom of Infonnation Act
Appendix I: Relevant Documents
Page 2
(FOIA) requests, and investigations by the Goverment Accountability Ofice (GAO)
and the Ofice of Special Counsel;
This interim policy does not supersede any other applicable law or higher level agency
directive, or existing labor management agreement in place as of this interim policy' s
effective date; and