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~ DEPARTMENTQF HEALTH AND HUMAN SERVICES
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""'=1nrI1.....D 20167
BY CERTIFIED MAIL
RElVRN RECEIPT REQUESTED
Paul H. Karnak
0701()..()67
Fel Schuylkill
Federal Correctionallnslitution
P,O. 80x 759
Minersville. PA 17954
PROPOSAL TO DEBAR
NOTICE OF OPPORnJNITY FOR HEARING
Doc:ket No. FDA-2007-N-oSOI 1
Dear Mr. Komak:
This letter is to inform you that the Food and Drog Administration (FDA) is proposing 10 issue an
order permanently debarring you from providing services in any capacity to a person that has an
approved or pending drug product application. FDA bases this proposal on a finding that you
were convicted of three felonies under federal law for condUCt relating to the development or
approval of a drug produa and otherwise rehlling to the regulalion of a dlUg product tmder the
Federal Food. Drug, and Cosmelic Act (the Act). This lena also offers you an opportunity 10
request a hearing on the proposal.
CondUd Related IQ Conviction
On January 18,2005. the Unite(! States District Court for the Northern District of New York
accepted your plea of guilty (plea agreement) and entered judgment against you for one count of
making and using a materially false statement in violation of 18 U.S .C. § 100I(a)(3), one count of
mail fraud in violation of 18 U.S.C. §§ 1341 and 1346, and one count of criminally negligent
homicide in violation of 18 U.S.C. § 13 and New York Penal Law § 125.10. The underlying facts
supporting these felony convictions are AS follows:
Beginning in October 2000, you were employed by the Department of Veterans Affairs as •
program specialist II the Suauoo Veterans Affairs Medical Center (Stratton) in Albany, New
Voli. At Stratton, you were the site coordinator for several pharmaceutical study prooxols.
I Lepcy Doctct No. 200'7N..c)4S2.
Paul H. Kornak
Docket No. FDA-W01-N..Q501
specifically the FeAST.! Tax 325.) Tax 327.· and DFMO' studies. These clinical Studies were
c:ondlJCted 10 evaluale Ihe safely and efficacy of drug products. Dall from such siudies are
cons)dered by FDA in detennining whether to gran! or withhold approvil of a drog product. Your
duties included coordinating pharmaceutical research proIocols. and )'OIl were responsible for
adhering 10 system SIaIldards and complying with research requiremenlS.
From about May 14. 1999.' through July 10. 2002. in oonnecIlon with conducting and
coon:Iinating clinical sllKlies al SlratlOll. including the FeAST. Tax 325. Tn 327. and DFMO
studies. you panicipated in I scheme to defraud the sponsors of these studies. by repeatedly
submilling fabc documentation and enrolling and causing to be enrolled persons as study subjcClS
who did DOl qualify under panicular study protocols. In addition to oIher specific acts died in the
plea Igreement. you admined to:
• Submilling a case report form with regard 10 I study subject knowing the doroment
contained materially false labonllOl)' entries and altered infonnation from I radiology
display report. whidl were critical facton in determining whether the individual was
eligible to panicipate in the Tax 325 study (violalion of 18 U.S.C. § 1001(1)(3».
• Knowingly and willfully misrepresenling the resullS of a blood chemistry analysis related
10 the panicipation of a Tax 325 study subjea who would 00l: ocherwise have met the
crileria for that study. The subjea. was adminislered the dlemolherapeulk drugs
doc:etaxel. cisplalin. and 5-ru in connccIlon with Tn 325 and died IS I result thereof.
Your failure to pcn.:eive a substanlialand Wljuslifiable risk thlt dealh would oocur when
)'01,1 knowingly and willfully made and used such false documenlS constituted a gross
deviation from the standard of care that a reasonable person would observe in the siluation
(violation of ,g U.S.C. §§ 1001(IX3)and 13. and New York Penal Law § 125.10».
• Knowing and willfully using interslatemail for lhe purpose of ueculing the aforesaid
scbeme and anifice to defraud. deprive. and obtain money and propeny (violation of 18
U.S.C. §§ 1341 and 1346).
On November 21, 2005. as a result of your guilty pleas. you were sentenced to 60 months in
prison on Count 1 (making and using false statements). 71 months in prison on Count 15 (mail
fraud) and 48 months in prison on Count 48 (criminally negligent homicide). all terms imposed
concurrently. You were also ordered to make restitulion to the sponsors of thc clinical studies: to
Aventis Phannaceuticals in the amounl of $488.907.58; to ILEX Oncology, Inc.• in the amount of
$14,017.47; and to the U.S. Depanmcnt of the Treasury for losses inculTed to the U.S.
Depanment of Veterans Affairs in the amounl of $135,850.
~ VA Coopentive Study 1410. the Iron (Fe) IIld Atherosclerotis (AST) Study known at "r-eAST." wu. c1iniCllllr;al
lh.il.llellled. new procedure for controlling atberosclerotis.
I This wu • randomized $Iudy of patients with Il\eIlSUllic or Iocilly recurreot Cll'ICeI" prevjou$ly uotte.ated will!
cbelll(llbenpy for ~VlJIC»d disease.
'11U$ wu • randomixod trial for patienu with metastatic 1lormoJle ~&ae1Ol"y prostale cancet.
I TllisUlldy eo~ the \1M! of difluorometJtyloraithine (DFMO) 10 the \1M! ofpllcebo in trealinc low. cr..x
I~ btlllkler cancet.
• Allhal time. until 0ctJber 21:00.)'00 W«e employed by Albany Research ln$tiIute.lnc.. at SlrllUlD.
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Paul H. Komak
Docket No. FDA·2007·N-0501
IDA's Finding
Section 306(a)(2)(A) of the Ac! (21 U.s.c. § 335a(a)(2)(A)) requires debarment of an individual
if FDA finds that the individual has been convicted of a felony under federal law for conduct
relating to the development or approval, including the process for development or approval. of
any drug product. Because the FeAST, Tax 315. Tax 327. and DFMO studies were conducted to
evaluate the safety and efflcacy of drug products. and FDA detennines whether to grant or
withhold approval of a drug product based. in pan, on the data from such studies. FDA finds that
the actions described in the plea agreement relate to both the development and approvil of drug
prodocu.
Seaion 306(1)(2)(B) of the Act (21 U.S.C. I 3353(1)(2)(B» requires debarment of an individual
if FDA fmds that the indivM1ual has been cooviaed of a felony under federal law for condlJCt
Olherwi.sc relating to the regulatKln of any dnlg product under the Act. FDA fmds that the
felonies referred to in the plea agreement were also for condUCl Olherwise relating to the
regulation of I drog product under the Act because it related to your conduct of drug studies
regulated by FDA.
Section 306(c)(2)(A)(ii) of the Act (21 U.S.C.1335a(c)(2)(A)(ii» requires that your debarment
be pennanen!.
Proposed belion and Notice ofOnooaunjty for Hearing
Based on the findings discussed above. FDA proposes to issue an order under section
306(a)(2)(A) and (B) of the Act pennantntly debarring you from providing services in any
capacity to 1 person having an approved or pending drug product application.
In accordaooe with section 306 of the Act and 21 CfR part 12. you are hereby given an
opportUnity to request 1 bearing to show why you should not be debancd.
If you decide to sed: a bearing, you must file the following: (I) on O£ befQtt 30 days from the
date of receipt of this letter, I wriuen OOl:ice of appearanoe and request for hearing; and (2) on Q£
before 60 days from the date of receipl of this letter, the information on which you rely to justify
a hearing. The procedures and requirements go,'erning this notice of opponunity for hearing, a
notice of appearance and request for a hearing, information and analyses to justify I hearing, and
a grant or dcnial of a hearing are contained in 21 CFR pan 12 and ~ion 306(i) of the Act (21
U.S.C. § 335a(i)).
Your failure to file a timely written notice of appearance and request for hearing constitutes an
election by you not to use the opportunity f()£ a bearing concerning your debannent and a waiver
of any contenlions concerning this action. If you do not request a hearing in the manner
prescribed by the regulations, the Agency will not bold a hearing and will issue a fmal debarment
order as proposed in this letter.
A request for. hearing rnay not rest upon mere allegations or denials but must present specifIC
faw showing that there is a genuine and substantial issue of fact that requires a bearing. A
bearing will be denied if !be data and information you submit, even if accuIate, are insufficient to
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Paul H. Komak
Docket No. FDA-2001-N-Q501
juslify!he factllal determination urged. If il conclllSively appears from the face of !he informalion
and factual analyses in yoor request for a heuing that there is no genuine and substantial issue of
fact that precludes the order of debannenl. the Commissioner of Food and Drugs will deny your
requesl for a hearing and mer a final order of debument.
You should understand lhat the facts underlying your conviction are not al iswe in this
proceeding. The only material issue is whe!her you were convicted IS alleged in this notice and,
if so, whether. 15 a malter of law, this conviction mandates your debumenl.
Your requesl for a hearing. including any infonnalion Of factual analyses relied on to justify a
hearing, must be Kienlified with Docket No. FDA-2OO1·N-Q501 and sent to the Division of
Dockets Management. Food and Drug Administration. 5630 Fishers lane, rm. 1061, Rockville.
~m :zo&j2. You must file four copies of all submissions pursuant 10 chis notice of opportunilY
for hearing. The public availability of information in these submissions is governed by 21 CFR
, 10.200). Publicly available submissions may be seen in the Diviston of Dockets Management
between 9 a.m. and 4 p.m., Monday lhroogh Friday.
This notice is issued under section 306 of the Feder1Il Food, Drug. and Cosmetic Act (21 U.S.C.
')35a) and under authority delegated to the Director, Office of Enforcement. Office of
Regulatory Affairs (FDA Staff Manual Guide 1410.35).
Sincerely,
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Alyson L. Saben
Acting Director
Office of Enforcement
Office of Regulatory Affairs
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