83 FR 63657 - David J. Fishman: Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 237 (December 11, 2018)

Page Range		63657-63658
FR Document		2018-26722

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. David J. Fishman for a period of 3 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Fishman was convicted of a misdemeanor under the FD&C Act for causing the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded. In addition, FDA has determined that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Dr. Fishman was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Fishman failed to request a hearing. Dr. Fishman's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.

Federal Register, Volume 83 Issue 237 (Tuesday, December 11, 2018)

[Federal Register Volume 83, Number 237 (Tuesday, December 11, 2018)]
[Notices]
[Pages 63657-63658]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26722]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1994]


David J. Fishman: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. 
David J. Fishman for a period of 3 years from providing services in any 
capacity to a person that has an approved or pending drug product 
application. FDA bases this order on a finding that Dr. Fishman was 
convicted of a misdemeanor under the FD&C Act for causing the 
introduction or delivery for introduction into interstate commerce of 
prescription drugs that were misbranded. In addition, FDA has 
determined that the type of conduct that served as the basis for the 
conviction undermines the process for the regulation of drugs. Dr. 
Fishman was given notice of the proposed debarment and an opportunity 
to request a hearing within the timeframe prescribed by regulation. Dr. 
Fishman failed to request a hearing. Dr. Fishman's failure to

[[Page 63658]]

request a hearing constitutes a waiver of his right to a hearing 
concerning this action.

DATES: This order is applicable December 11, 2018.

ADDRESSES: Submit applications for termination of debarment to the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Enforcement, 
Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 
301-796-4640.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 
335a(b)(2)(B)(i)(I)) permits debarment of an individual if FDA finds 
that the individual has been convicted of a misdemeanor under Federal 
law for conduct relating to the regulation of drug products under the 
FD&C Act, and if FDA finds that the type of conduct that served as the 
basis for the conviction undermines the process for the regulation of 
drugs.
    On November 19, 2013, in the United States District Court for the 
Northern District of Ohio, judgment was entered against Dr. Fishman 
after he entered a plea of guilty to one count of misbranding, in 
violation of section 301(a) of the FD&C Act (21 U.S.C. 331(a)), which 
is a misdemeanor offense under section 303(a)(1) of the FD&C Act (21 
U.S.C. 333(a)(1)).
    FDA's finding that debarment is appropriate is based on the 
misdemeanor conviction referenced herein. The factual basis for this 
conviction is as follows: Between January 10, 2006, and March 12, 2009, 
Dr. Fishman was a physician (oncologist) in Ohio. During this time, Dr. 
Fishman purchased and received oncology drugs, including TAXOTERE 
(docetaxel) and NOVANTRONE (mitoxantrone), from a drug distributor 
located in Canada. These new drugs originated outside the United States 
and were not approved by FDA for introduction or delivery for 
introduction into interstate commerce in the United States. Thus, Dr. 
Fishman caused the introduction or delivery for introduction into 
interstate commerce of prescription drugs that were misbranded for 
lacking adequate directions for use in their labeling.
    As a result of this conviction, on July 27, 2018, FDA sent Dr. 
Fishman a notice by certified mail proposing to debar him for 3 years 
from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal was based on 
a finding under section 306(b)(2)(B)(i)(I) of the FD&C Act that Dr. 
Fishman was convicted of a misdemeanor under Federal law for conduct 
relating to the regulation of drug products under the FD&C Act, and 
that the type of conduct that served as the basis for the conviction 
undermines the process for the regulation of drugs.
    The proposal offered Dr. Fishman an opportunity to request a 
hearing, providing him 30 days from the date of receipt of the letter 
in which to file the request, and advised him that failure to request a 
hearing constituted a waiver of the opportunity for a hearing and of 
any contentions concerning this action. Dr. Fishman received the 
proposal on August 2, 2018. Dr. Fishman did not request a hearing 
within the timeframe prescribed by regulation and has, therefore, 
waived his opportunity for a hearing and has waived any contentions 
concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import 
Operations, Office of Regulatory Affairs, under section 
306(b)(2)(B)(i)(I) of the FD&C Act, under authority delegated to the 
Director (Staff Manual Guide 1410.35), finds that Dr. David J. Fishman 
has been convicted of a misdemeanor under Federal law for conduct 
relating to the regulation of drug products under the FD&C Act, and 
that the type of conduct that served as the basis for the conviction 
undermines the process for the regulation of drugs.
    As a result of the foregoing findings and in consideration of the 
factors described in section 306(c)(3) of the FD&C Act, Dr. David J. 
Fishman is debarred for 3 years from providing services in any capacity 
to a person with an approved or pending drug product application under 
sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 
382), or under section 351 of the Public Health Service Act (42 U.S.C. 
262), effective (see DATES) (see sections 306(c)(1)(B), (c)(3), and 
201(dd) (21 U.S.C. 321(dd)) of the FD&C Act). Any person with an 
approved or pending drug product application who knowingly employs or 
retains as a consultant or contractor, or otherwise uses the services 
of Dr. Fishman in any capacity during his debarment, will be subject to 
civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 
335b(a)(6)). If Dr. Fishman provides services in any capacity to a 
person with an approved or pending drug product application during his 
period of debarment, he will be subject to civil money penalties 
(section 307(a)(7) of the FD&C Act). In addition, FDA will not accept 
or review any abbreviated new drug applications submitted by or with 
the assistance of Dr. Fishman during his period of debarment (section 
306(c)(1)(B) of the FD&C Act).
    Any application by Dr. Fishman for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2018-N-1994 and sent to the Dockets Management Staff (see 
ADDRESSES). All such submissions are to be filed in four copies. The 
public availability of information in these submissions is governed by 
21 CFR 10.20(j).
    Publicly available submissions will be placed in the docket and 
will be viewable at https://www.regulations.gov or at the Dockets 
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: December 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26722 Filed 12-10-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 237 / Tuesday, December 11, 2018 / Notices 63657

debarment and an opportunity to 3 years from providing services in any application during her period of
request a hearing within the timeframe capacity to a person that has an debarment, she will be subject to civil
prescribed by regulation. Dr. Kuo failed approved or pending drug product money penalties (section 307(a)(7) of the
to request a hearing. Dr. Kuo’s failure to application. The proposal was based on FD&C Act). In addition, FDA will not
request a hearing constitutes a waiver of a finding under section 306(b)(2)(B)(i)(I) accept or review any abbreviated new
her right to a hearing concerning this of the FD&C Act that Dr. Kuo was drug applications submitted by or with
action. convicted of a misdemeanor under the assistance of Dr. Kuo during her
DATES: This order is applicable Federal law for conduct relating to the period of debarment (section
December 11, 2018. regulation of drug products under the 306(c)(1)(B) of the FD&C Act).
FD&C Act, and that the type of conduct Any application by Dr. Kuo for
ADDRESSES: Submit applications for
that served as the basis for the termination of debarment under section
termination of debarment to the Dockets
conviction undermines the process for 306(d)(1) of the FD&C Act should be
Management Staff (HFA–305), Food and
the regulation of drugs. identified with Docket No. FDA–2018–
Drug Administration, 5630 Fishers The proposal offered Dr. Kuo an
Lane, Rm. 1061, Rockville, MD 20852. N–1990 and sent to the Dockets
opportunity to request a hearing, Management Staff (see ADDRESSES). All
FOR FURTHER INFORMATION CONTACT: provided her 30 days from the date of such submissions are to be filed in four
Kenny Shade, Division of Enforcement, receipt of the letter in which to file the copies. The public availability of
Food and Drug Administration, 12420 request, and advised her that failure to information in these submissions is
Parklawn Dr., Rockville, MD 20857, request a hearing constituted a waiver of governed by 21 CFR 10.20(j).
301–796–4640. the opportunity for a hearing and of any Publicly available submissions will be
SUPPLEMENTARY INFORMATION: contentions concerning this action. Dr. placed in the docket and will be
I. Background Kuo received the proposal on July 23, viewable at https://www.regulations.gov
2018. Dr. Kuo did not request a hearing or at the Dockets Management Staff (see
Section 306(b)(2)(B)(i)(I) of the FD&C within the timeframe prescribed by ADDRESSES) between 9 a.m. and 4 p.m.,
Act (21 U.S.C. 335a(b)(2)(B)(i)(I)) regulation and has, therefore, waived
permits debarment of an individual if Monday through Friday.
her opportunity for a hearing and has
FDA finds that the individual has been waived any contentions concerning her Dated: December 4, 2018.
convicted of a misdemeanor under debarment (21 CFR part 12). Leslie Kux,
Federal law for conduct relating to the Associate Commissioner for Policy.
regulation of drug products under the II. Findings and Order
[FR Doc. 2018–26778 Filed 12–10–18; 8:45 am]
FD&C Act, and if FDA finds that the Therefore, the Director, Office of BILLING CODE 4164–01–P
type of conduct that served as the basis Enforcement and Import Operations,
for the conviction undermines the Office of Regulatory Affairs, under
process for the regulation of drugs. section 306(b)(2)(B)(i)(I) of the FD&C DEPARTMENT OF HEALTH AND
On January 14, 2014, in the United Act, under authority delegated to the HUMAN SERVICES
States District Court for the Northern Director (Staff Manual Guide 1410.35),
District of Ohio, judgment was entered finds that Dr. Su-Chiao Kuo has been Food and Drug Administration
against Dr. Kuo after she entered a plea convicted of a misdemeanor under
[Docket No. FDA–2018–N–1994]
of guilty to one count of misbranding, in Federal law for conduct relating to the
violation of section 301(a) of the FD&C regulation of drug products under the David J. Fishman: Debarment Order
Act (21 U.S.C. 331(a)), which is a FD&C Act and that the type of conduct
misdemeanor offense under section that served as the basis for the AGENCY: Food and Drug Administration,
303(a)(1) of the FD&C Act (21 U.S.C. conviction undermines the process for HHS.
333(a)(1)). the regulation of drugs. ACTION: Notice.
FDA’s finding that debarment is As a result of the foregoing findings
appropriate is based on the and in consideration of the factors SUMMARY: The Food and Drug
misdemeanor conviction referenced described in section 306(c)(3) of the Administration (FDA) is issuing an
herein. The factual basis for this FD&C Act, Dr. Su-Chiao Kuo is debarred order under the Federal Food, Drug, and
conviction is as follows: Between June for 3 years from providing services in Cosmetic Act (FD&C Act) debarring Dr.
22, 2005, and November 18, 2008, Dr. any capacity to a person with an David J. Fishman for a period of 3 years
Kuo was a physician (oncologist) in approved or pending drug product from providing services in any capacity
Ohio. During this time, Dr. Kuo application under sections 505, 512, or to a person that has an approved or
purchased and received oncology drugs, 802 of the FD&C Act (21 U.S.C. 355, pending drug product application. FDA
including TAXOTERE (docetaxel) and 360b, or 382), or under section 351 of bases this order on a finding that Dr.
ZOMETA (zoledronic acid), from a drug the Public Health Service Act (42 U.S.C. Fishman was convicted of a
distributor located in Canada. These 262), effective (see DATES) (see sections misdemeanor under the FD&C Act for
new drugs originated outside the United 306(c)(1)(B), (c)(3), and 201(dd) (21 causing the introduction or delivery for
States and were not approved by FDA U.S.C. 321(dd)) of the FD&C Act). Any introduction into interstate commerce of
for introduction or delivery for person with an approved or pending prescription drugs that were
introduction into interstate commerce in drug product application who misbranded. In addition, FDA has
the United States. Thus, Dr. Kuo caused knowingly employs or retains as a determined that the type of conduct that
the introduction or delivery for consultant or contractor, or otherwise served as the basis for the conviction
amozie on DSK3GDR082PROD with NOTICES1

introduction into interstate commerce of uses the services of Dr. Kuo in any undermines the process for the
prescription drugs that were capacity during her debarment, will be regulation of drugs. Dr. Fishman was
misbranded for lacking adequate subject to civil money penalties (section given notice of the proposed debarment
directions for use in their labeling. 307(a)(6) of the FD&C Act (21 U.S.C. and an opportunity to request a hearing
As a result of this conviction, on July 335b(a)(6)). If Dr. Kuo provides services within the timeframe prescribed by
13, 2018, FDA sent Dr. Kuo a notice by in any capacity to a person with an regulation. Dr. Fishman failed to request
certified mail proposing to debar her for approved or pending drug product a hearing. Dr. Fishman’s failure to

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63658 Federal Register / Vol. 83, No. 237 / Tuesday, December 11, 2018 / Notices

request a hearing constitutes a waiver of application. The proposal was based on money penalties (section 307(a)(7) of the
his right to a hearing concerning this a finding under section 306(b)(2)(B)(i)(I) FD&C Act). In addition, FDA will not
action. of the FD&C Act that Dr. Fishman was accept or review any abbreviated new
DATES: This order is applicable convicted of a misdemeanor under drug applications submitted by or with
December 11, 2018. Federal law for conduct relating to the the assistance of Dr. Fishman during his
regulation of drug products under the period of debarment (section
ADDRESSES: Submit applications for
FD&C Act, and that the type of conduct 306(c)(1)(B) of the FD&C Act).
termination of debarment to the Dockets
that served as the basis for the Any application by Dr. Fishman for
Management Staff (HFA–305), Food and
conviction undermines the process for termination of debarment under section
Drug Administration, 5630 Fishers
the regulation of drugs. 306(d)(1) of the FD&C Act should be
Lane, Rm. 1061, Rockville, MD 20852. The proposal offered Dr. Fishman an identified with Docket No. FDA–2018–
FOR FURTHER INFORMATION CONTACT: opportunity to request a hearing, N–1994 and sent to the Dockets
Kenny Shade, Division of Enforcement, providing him 30 days from the date of Management Staff (see ADDRESSES). All
Food and Drug Administration, 12420 receipt of the letter in which to file the such submissions are to be filed in four
Parklawn Dr., Rockville, MD 20857, request, and advised him that failure to copies. The public availability of
301–796–4640. request a hearing constituted a waiver of information in these submissions is
SUPPLEMENTARY INFORMATION: the opportunity for a hearing and of any governed by 21 CFR 10.20(j).
I. Background contentions concerning this action. Dr. Publicly available submissions will be
Fishman received the proposal on placed in the docket and will be
Section 306(b)(2)(B)(i)(I) of the FD&C August 2, 2018. Dr. Fishman did not viewable at https://www.regulations.gov
Act (21 U.S.C. 335a(b)(2)(B)(i)(I)) request a hearing within the timeframe or at the Dockets Management Staff (see
permits debarment of an individual if prescribed by regulation and has, ADDRESSES) between 9 a.m. and 4 p.m.,
FDA finds that the individual has been therefore, waived his opportunity for a Monday through Friday.
convicted of a misdemeanor under hearing and has waived any contentions
Federal law for conduct relating to the Dated: December 4, 2018.
concerning his debarment (21 CFR part
regulation of drug products under the 12). Leslie Kux,
FD&C Act, and if FDA finds that the Associate Commissioner for Policy.
type of conduct that served as the basis II. Findings and Order [FR Doc. 2018–26722 Filed 12–10–18; 8:45 am]
for the conviction undermines the Therefore, the Director, Office of BILLING CODE 4164–01–P
process for the regulation of drugs. Enforcement and Import Operations,
On November 19, 2013, in the United Office of Regulatory Affairs, under
States District Court for the Northern section 306(b)(2)(B)(i)(I) of the FD&C DEPARTMENT OF HEALTH AND
District of Ohio, judgment was entered Act, under authority delegated to the HUMAN SERVICES
against Dr. Fishman after he entered a Director (Staff Manual Guide 1410.35),
plea of guilty to one count of finds that Dr. David J. Fishman has been Food and Drug Administration
misbranding, in violation of section convicted of a misdemeanor under [Docket No. FDA–2018–N–4162]
301(a) of the FD&C Act (21 U.S.C. Federal law for conduct relating to the
331(a)), which is a misdemeanor offense regulation of drug products under the The Tobacco Products Scientific
under section 303(a)(1) of the FD&C Act FD&C Act, and that the type of conduct Advisory Committee; Notice of Meeting
(21 U.S.C. 333(a)(1)). that served as the basis for the
FDA’s finding that debarment is conviction undermines the process for AGENCY: Food and Drug Administration,
appropriate is based on the the regulation of drugs. HHS.
misdemeanor conviction referenced As a result of the foregoing findings ACTION: Notice.
herein. The factual basis for this and in consideration of the factors
conviction is as follows: Between described in section 306(c)(3) of the SUMMARY: The Food and Drug
January 10, 2006, and March 12, 2009, FD&C Act, Dr. David J. Fishman is Administration (FDA) announces a
Dr. Fishman was a physician debarred for 3 years from providing forthcoming public advisory committee
(oncologist) in Ohio. During this time, services in any capacity to a person with meeting of the Tobacco Products
Dr. Fishman purchased and received an approved or pending drug product Scientific Advisory Committee (the
oncology drugs, including TAXOTERE application under sections 505, 512, or Committee). The general function of the
(docetaxel) and NOVANTRONE 802 of the FD&C Act (21 U.S.C. 355, Committee is to provide advice and
(mitoxantrone), from a drug distributor 360b, or 382), or under section 351 of recommendations to the Agency on
located in Canada. These new drugs the Public Health Service Act (42 U.S.C. FDA’s regulatory issues. The meeting
originated outside the United States and 262), effective (see DATES) (see sections will be open to the public.
were not approved by FDA for 306(c)(1)(B), (c)(3), and 201(dd) (21 DATES: The meeting will be held on
introduction or delivery for introduction U.S.C. 321(dd)) of the FD&C Act). Any February 6, 2019, from 8:30 a.m. to 5
into interstate commerce in the United person with an approved or pending p.m. and on February 7, 2019 from 8
States. Thus, Dr. Fishman caused the drug product application who a.m. to 1 p.m.
introduction or delivery for introduction knowingly employs or retains as a ADDRESSES: FDA White Oak Conference
into interstate commerce of prescription consultant or contractor, or otherwise Center, Bldg. 31, Rm. 1503 (the Great
drugs that were misbranded for lacking uses the services of Dr. Fishman in any Room), 10903 New Hampshire Ave.,
adequate directions for use in their capacity during his debarment, will be Silver Spring, MD 20993–0002. Answers
amozie on DSK3GDR082PROD with NOTICES1

labeling. subject to civil money penalties (section to commonly asked questions including
As a result of this conviction, on July 307(a)(6) of the FD&C Act (21 U.S.C. information regarding special
27, 2018, FDA sent Dr. Fishman a notice 335b(a)(6)). If Dr. Fishman provides accommodations due to a disability,
by certified mail proposing to debar him services in any capacity to a person with visitor parking, and transportation may
for 3 years from providing services in an approved or pending drug product be accessed at: https://www.fda.gov/
any capacity to a person that has an application during his period of AdvisoryCommittees/AboutAdvisory
approved or pending drug product debarment, he will be subject to civil Committees/ucm408555.htm.

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Document Created: 2018-12-11 01:07:20
Document Modified: 2018-12-11 01:07:20

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		This order is applicable December 11, 2018.
Contact		Kenny Shade, Division of Enforcement, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 301-796-4640.
FR Citation		83 FR 63657

83 FR 63657 - David J. Fishman: Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 237 (December 11, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration