Gerald Tighe: Final Debarment Order, 15790-15791 [2020-05714]
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Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices
TABLE 1—CDER MEETINGS POSTPONED OR CANCELLED
Meeting type
Meeting title
Original meeting
date
Docket No.
Federal Register
citation
Public Meeting ........
Patient-Focused Drug Development for Stimulant Use Disorder.
Patient-Focused Drug Development for Vitiligo
Mar. 10, 2020 ........
FDA–2020–N–0259 .....
Mar. 30, 2020 ........
FDA–2020–N–0255 .....
Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials.
Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.
Apr. 16, 2020 .........
FDA–2020–N–0001 .....
Apr. 22, 2020 .........
FDA–2018–N–4337 .....
85 FR 8877, Feb. 18,
2020.
85 FR 8004, Feb. 12,
2020.
85 FR 14207, Mar. 11,
2020.
85 FR 6547, Feb. 5,
2020.
Public Meeting ........
Public Meeting ........
Public Meeting ........
TABLE 2—CDER MEETING HELD REMOTELY
Meeting type
Meeting title
Original meeting
date
Docket No.
Public Meeting .........
United States Food and Drug
Administration and Health
Canada Joint Regional Consultation on the International
Council for Harmonisation of
Technical Requirements for
Pharmaceuticals for Human
Use.
Apr. 3, 2020 ...........
FDA–2020–N–
0256.
Dated: March 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–05743 Filed 3–18–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3591]
Gerald Tighe: Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) permanently debarring Gerald
Tighe 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 Mr. Tighe was convicted of
a felony under Federal law for conduct
that relates to the regulation of a drug
product under the FD&C Act. Mr. Tighe
was given notice of the proposed
permanent debarment and an
opportunity to request a hearing within
the timeframe prescribed by regulation.
Mr. Tighe failed to respond. Mr. Tighe’s
failure to request a hearing within the
prescribed timeframe constitutes a
waiver of his right to a hearing
concerning this action.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:05 Mar 18, 2020
Jkt 250001
This order is applicable March
19, 2020.
ADDRESSES: Submit applications for
special 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:
Jaime Espinosa, Division of
Enforcement, Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, debarments@
fda.hhs.gov, or 240–402–8743.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
Section 306(a)(2)(B) of the FD&C Act
(21 U.S.C. 335a(a)(2)(B)) 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 regulation of any
drug product under the FD&C Act. On
July 14, 2017, Mr. Tighe pleaded guilty
to one count of conspiracy to commit
wire fraud, a felony offense, in violation
of 18 U.S.C. 371. On December 19, 2017,
judgment was entered against Mr. Tighe
in the U. S. District Court for the Eastern
District of New York.
The factual basis for this conviction is
as follows: Mr. Tighe was the founder,
sole owner, and president of Med Prep
Consulting, Inc. (Med Prep), a medical
drug repackager located and
incorporated in New Jersey in 1994.
Med Prep manufactured, repackaged,
processed, packed, labeled, held,
PO 00000
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Fmt 4703
Sfmt 4703
Federal Register citation
Remote information
85 FR 13659,
https://www.fda.gov/drugs/
Mar. 9, 2020.
news-events-human-drugs/
health-canada-and-fda-jointpublic-consultation-international-councilharmonisation-technical-0.
compounded, and distributed various
drug products, including pain
management medications, anesthesia
and operating room drugs, and oncology
and dialysis drugs. As president of Med
Prep, Mr. Tighe was the highest-ranking
corporate official, and he was
responsible for and oversaw all aspects
of its business, including its
manufacturing and quality operations.
Between approximately January 2007
and April 2013, Mr. Tighe knowingly
and intentionally conspired with other
individuals to devise a scheme and
artifice to defraud healthcare providers
and to obtain money and property from
them by means of materially false and
fraudulent pretenses, representations,
and promises, and for the purpose of
executing such scheme and artifice, and
attempting to do so, to transmit and
cause to be transmitted, by means of
wire communication in interstate
commerce, writings, signs, signals,
pictures, and sounds.
Specifically, during this time period,
Mr. Tighe conspired with others to
introduce and introduced, or caused the
introduction of, adulterated and
misbranded drugs into interstate
commerce, all with the intent to defraud
and mislead healthcare providers. The
adulterated drugs Mr. Tighe introduced
or caused to be introduced into
interstate commerce were adulterated
because they were prepared, packed,
and held under insanitary conditions
and because the drugs consisted in
whole or in part of a filthy, putrid, and
decomposed substance. The misbranded
drugs Mr. Tighe introduced or caused to
E:\FR\FM\19MRN1.SGM
19MRN1
jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices
be introduced in interstate commerce
were misbranded because the drugs
were dangerous to health when used as
labeled and because the labeling on the
drugs regarding use by dates and the
strength of the ingredients were false
and misleading. Mr. Tighe assured
healthcare providers that they were
receiving drug products from Med Prep
that were produced in full compliance
with the law, were compounded and
packaged in compliance with chapter
797 of the United States Pharmacopeia
(USP 797) and would be safe for
patients. Mr. Tighe also told healthcare
providers that the beyond use dates that
Mr. Tighe assigned to sterile drug
products were supported by sterility
testing that satisfied the requirements of
USP 797. These representations were
made in, among other places, quarterly
reports that were sent by email to
healthcare providers and on Med Prep’s
website. Mr. Tighe did not inform
healthcare providers of failures to
comply with USP 797 and basic sterility
practices, and breaches of aseptic
technique in Med Prep’s cleanroom,
which occurred repeatedly at Med
Prep’s facility.
By engaging in this conduct, Mr.
Tighe violated Federal and State law
applicable to drug preparation and
created serious risks for patients who
were being treated for cancer and other
illnesses. Mr. Tighe misrepresented the
quality of Med Prep’s drug processing
and repackaging operations to increase
market share, and he engaged in
substandard practices to save money
and increase his profits. Relying on
these misrepresentations and omissions,
healthcare providers paid Med Prep
approximately $34,970,881 for its
services between approximately 2007
and 2012.
Based on his conviction, FDA sent
Mr. Tighe by certified mail on October
25, 2019, a notice proposing to
permanently debar him 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(a)(2)(B) of the FD&C Act, that Mr.
Tighe was convicted, as set forth in
section 306(l)(1) of the FD&C Act, of a
felony under Federal law for conduct
relating to the regulation of a drug
product under the FD&C Act. The
proposal also offered Mr. Tighe 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
file a timely request for a hearing
constituted a waiver of the opportunity
for a hearing and of any contentions
concerning this action. Mr. Tighe
VerDate Sep<11>2014
17:05 Mar 18, 2020
Jkt 250001
15791
received the proposal on October 31,
2019. Mr. Tighe did not request a
hearing and has, therefore, waived his
opportunity for a hearing and any
contentions concerning his debarment
(21 CFR part 12).
Dated: March 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
II. Findings and Order
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Gerald Tighe
has been convicted of a felony under
Federal law for conduct relating to the
regulation of a drug product under the
FD&C Act.
As a result of the foregoing finding,
Gerald Tighe is permanently debarred
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), applicable
(see DATES) (see sections 201(dd) and
306(c)(1)(B) and (c)(2)(A)(ii) of the FD&C
Act (21 U.S.C. 321(dd) and 335a(c)(1)(B)
and (c)(2)(A)(ii))). Any person with an
approved or pending drug product
application who knowingly employs or
retains as a consultant or contractor, or
otherwise uses in any capacity the
services of Gerald Tighe 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 Mr.
Tighe 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
from Mr. Tighe during his period of
debarment (section 306(c)(1)(B) of the
FD&C Act).
Any application by Mr. Tighe for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2019–N–3591 and sent to the
Dockets Management Staff (see
ADDRESSES). You can submit only one
copy for all such submissions. The
public availability of information in
these submissions is governed by 21
CFR 10.20.
Publicly available submissions may
be seen in the Dockets Management
Staff between 9 a.m. and 4 p.m.,
Monday through Friday.
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
[FR Doc. 2020–05714 Filed 3–18–20; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2019–N–4054]
Brenda Elise Edwards: Final
Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) permanently debarring Brenda
Elise Edwards 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 Mrs. Edwards was
convicted of a felony under Federal law
for conduct that relates to the regulation
of a drug product under the FD&C Act.
Mrs. Edwards was given notice of the
proposed permanent debarment and
was given an opportunity to request a
hearing to show why she should not be
debarred. As of January 2, 2020 (30 days
after receipt of the notice), Mrs.
Edwards had not responded. Mrs.
Edwards’s failure to respond and
request a hearing constitutes a waiver of
her right to a hearing concerning this
action.
SUMMARY:
This order is applicable March
19, 2020.
ADDRESSES: Submit applications for
special 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:
Jaime Espinosa, Division of
Enforcement, Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, debarments@
fda.hhs.gov, 240–402–8743.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
Section 306(a)(2)(B) of the FD&C Act
(21 U.S.C. 335a(a)(2)(B)) requires
debarment of an individual from
providing services in any capacity to a
person that has an approved or pending
E:\FR\FM\19MRN1.SGM
19MRN1
]]>Agencies
[Federal Register Volume 85, Number 54 (Thursday, March 19, 2020)]
[Notices]
[Pages 15790-15791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05714]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3591]
Gerald Tighe: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
permanently debarring Gerald Tighe 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 Mr. Tighe was
convicted of a felony under Federal law for conduct that relates to the
regulation of a drug product under the FD&C Act. Mr. Tighe was given
notice of the proposed permanent debarment and an opportunity to
request a hearing within the timeframe prescribed by regulation. Mr.
Tighe failed to respond. Mr. Tighe's failure to request a hearing
within the prescribed timeframe constitutes a waiver of his right to a
hearing concerning this action.
DATES: This order is applicable March 19, 2020.
ADDRESSES: Submit applications for special 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: Jaime Espinosa, Division of
Enforcement, Office of Strategic Planning and Operational Policy,
Office of Regulatory Affairs, Food and Drug Administration, 12420
Parklawn Dr., Rockville, MD 20857, [email protected], or 240-402-
8743.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
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 regulation of any drug product under the FD&C Act. On July 14,
2017, Mr. Tighe pleaded guilty to one count of conspiracy to commit
wire fraud, a felony offense, in violation of 18 U.S.C. 371. On
December 19, 2017, judgment was entered against Mr. Tighe in the U. S.
District Court for the Eastern District of New York.
The factual basis for this conviction is as follows: Mr. Tighe was
the founder, sole owner, and president of Med Prep Consulting, Inc.
(Med Prep), a medical drug repackager located and incorporated in New
Jersey in 1994. Med Prep manufactured, repackaged, processed, packed,
labeled, held, compounded, and distributed various drug products,
including pain management medications, anesthesia and operating room
drugs, and oncology and dialysis drugs. As president of Med Prep, Mr.
Tighe was the highest-ranking corporate official, and he was
responsible for and oversaw all aspects of its business, including its
manufacturing and quality operations. Between approximately January
2007 and April 2013, Mr. Tighe knowingly and intentionally conspired
with other individuals to devise a scheme and artifice to defraud
healthcare providers and to obtain money and property from them by
means of materially false and fraudulent pretenses, representations,
and promises, and for the purpose of executing such scheme and
artifice, and attempting to do so, to transmit and cause to be
transmitted, by means of wire communication in interstate commerce,
writings, signs, signals, pictures, and sounds.
Specifically, during this time period, Mr. Tighe conspired with
others to introduce and introduced, or caused the introduction of,
adulterated and misbranded drugs into interstate commerce, all with the
intent to defraud and mislead healthcare providers. The adulterated
drugs Mr. Tighe introduced or caused to be introduced into interstate
commerce were adulterated because they were prepared, packed, and held
under insanitary conditions and because the drugs consisted in whole or
in part of a filthy, putrid, and decomposed substance. The misbranded
drugs Mr. Tighe introduced or caused to
[[Page 15791]]
be introduced in interstate commerce were misbranded because the drugs
were dangerous to health when used as labeled and because the labeling
on the drugs regarding use by dates and the strength of the ingredients
were false and misleading. Mr. Tighe assured healthcare providers that
they were receiving drug products from Med Prep that were produced in
full compliance with the law, were compounded and packaged in
compliance with chapter 797 of the United States Pharmacopeia (USP 797)
and would be safe for patients. Mr. Tighe also told healthcare
providers that the beyond use dates that Mr. Tighe assigned to sterile
drug products were supported by sterility testing that satisfied the
requirements of USP 797. These representations were made in, among
other places, quarterly reports that were sent by email to healthcare
providers and on Med Prep's website. Mr. Tighe did not inform
healthcare providers of failures to comply with USP 797 and basic
sterility practices, and breaches of aseptic technique in Med Prep's
cleanroom, which occurred repeatedly at Med Prep's facility.
By engaging in this conduct, Mr. Tighe violated Federal and State
law applicable to drug preparation and created serious risks for
patients who were being treated for cancer and other illnesses. Mr.
Tighe misrepresented the quality of Med Prep's drug processing and
repackaging operations to increase market share, and he engaged in
substandard practices to save money and increase his profits. Relying
on these misrepresentations and omissions, healthcare providers paid
Med Prep approximately $34,970,881 for its services between
approximately 2007 and 2012.
Based on his conviction, FDA sent Mr. Tighe by certified mail on
October 25, 2019, a notice proposing to permanently debar him 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(a)(2)(B) of the FD&C Act, that Mr. Tighe was
convicted, as set forth in section 306(l)(1) of the FD&C Act, of a
felony under Federal law for conduct relating to the regulation of a
drug product under the FD&C Act. The proposal also offered Mr. Tighe 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 file a timely request for a hearing constituted a
waiver of the opportunity for a hearing and of any contentions
concerning this action. Mr. Tighe received the proposal on October 31,
2019. Mr. Tighe did not request a hearing and has, therefore, waived
his opportunity for a hearing and any contentions concerning his
debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Gerald
Tighe has been convicted of a felony under Federal law for conduct
relating to the regulation of a drug product under the FD&C Act.
As a result of the foregoing finding, Gerald Tighe is permanently
debarred 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), applicable (see
DATES) (see sections 201(dd) and 306(c)(1)(B) and (c)(2)(A)(ii) of the
FD&C Act (21 U.S.C. 321(dd) and 335a(c)(1)(B) and (c)(2)(A)(ii))). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses in any capacity the services of Gerald Tighe 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 Mr. Tighe 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 from
Mr. Tighe during his period of debarment (section 306(c)(1)(B) of the
FD&C Act).
Any application by Mr. Tighe for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2019-N-3591 and sent to the Dockets Management Staff
(see ADDRESSES). You can submit only one copy for all such submissions.
The public availability of information in these submissions is governed
by 21 CFR 10.20.
Publicly available submissions may be seen in the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Dated: March 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05714 Filed 3-18-20; 8:45 am]
BILLING CODE 4164-01-P
