Gabriel J. Letizia, Jr.: Final Debarment Order, 2935-2937 [2023-00791]
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Federal Register / Vol. 88, No. 11 / Wednesday, January 18, 2023 / Notices
has determined that OFIRMEV
(acetaminophen) injection, 1,000
milligrams (mg)/100 milliliters (mL) (10
mg/mL), was not withdrawn from sale
for reasons of safety or effectiveness.
This determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for
acetaminophen injection, 1,000 mg/100
mL (10 mg/mL), if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Kaetochi Okemgbo, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6224,
Silver Spring, MD 20993–0002, 301–
796–1546, Kaetochi.Okemgbo@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
OFIRMEV (acetaminophen) injection,
1,000 mg/100 mL (10 mg/mL), is the
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subject of NDA 022450, held by
Mallinckrodt Hospital Products IP Ltd.
(Mallinckrodt), and initially approved
on November 2, 2010. OFIRMEV is
indicated for management of mild to
moderate pain in adult and pediatric
patients 2 years and older, management
of moderate to severe pain with
adjunctive opioid analgesics in adult
and pediatric patients 2 years and older,
and reduction of fever in adult and
pediatric patients.
In a letter dated June 24, 2021,
Mallinckrodt notified FDA that
OFIRMEV (acetaminophen) injection,
1,000 mg/100 mL (10 mg/mL), was
being discontinued, and FDA moved the
drug product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Nines Consult Pharma, LLC,
submitted a citizen petition dated
August 22, 2022 (Docket No. FDA–
2022–P–1982), under 21 CFR 10.30,
requesting that the Agency determine
whether OFIRMEV (acetaminophen)
injection, 1,000 mg/100 mL (10 mg/mL),
was withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that OFIRMEV
(acetaminophen) injection, 1,000 mg/
100 mL (10 mg/mL), was not withdrawn
for reasons of safety or effectiveness.
The petitioner has identified no data or
other information suggesting that this
drug product was withdrawn for reasons
of safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of OFIRMEV
(acetaminophen) injection, 1,000 mg/
100 mL (10 mg/mL), from sale. We have
also independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list OFIRMEV
(acetaminophen) injection, 1,000 mg/
100 mL (10 mg/mL), in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to OFIRMEV (acetaminophen) injection,
1,000 mg/100 mL (10 mg/mL), may be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
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2935
for this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: January 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–00792 Filed 1–17–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–1600]
Gabriel J. Letizia, Jr.: Final Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) permanently
debarring Gabriel J. Letizia, Jr. 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. Letizia
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. Letizia was given notice
of the proposed permanent debarment
and was given an opportunity to request
a hearing to show why he should not be
debarred within the timeframe
prescribed by regulation. Mr. Letizia has
not responded to the notice. Mr.
Letizia’s failure to respond and request
a hearing within the prescribed
timeframe constitutes a waiver of his
right to a hearing concerning this action.
DATES: This order is applicable January
18, 2023.
ADDRESSES: Submit applications for
special termination of debarment to the
Dockets Management Staff, Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
240–402–7500, or at https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of Compliance
and Enforcement, Office of Policy,
Compliance, and Enforcement, Office of
Regulatory Affairs, Food and Drug
Administration, 240–402–8743, or at
debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Section 306(a)(2)(B) of the FD&C Act
(21 U.S.C. 335a(a)(2)(B)) requires
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Federal Register / Vol. 88, No. 11 / Wednesday, January 18, 2023 / Notices
debarment of an individual from
providing services in any capacity to a
person that has an approved or pending
drug product application 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
May 18, 2022, Mr. Letizia was convicted
in the U.S. District Court for the
Southern District of New York, of one
felony count of conspiracy to commit
wire fraud in violation of 18 U.S.C. 371,
and two misdemeanor counts of
misbranding in violation of 21 U.S.C.
331(a) and 333(a)(1). FDA’s finding that
debarment is appropriate is based on the
felony conviction referenced herein.
The factual basis for this conviction is
as follows: As contained in the
Superseding Information in Mr. Letizia’s
case, filed May 4, 2021, and from the
transcript of his guilty plea hearing,
filed on May 26, 2021, Mr. Letizia was
the owner and executive director of
AMA Laboratories (AMA), a consumer
product testing company in Rockland
County, New York. Mr. Letizia began
operating AMA in the early 1980s and
became its sole owner in approximately
2003. Mr. Letizia falsely used the title
‘‘Dr.’’ in correspondence, falsely
representing to customers that he held
a Ph.D. AMA purported to test the safety
and efficacy of cosmetics, sunscreens,
and other products on specified
numbers of volunteer panelists for
consumer products companies. AMA’s
customers would use the test results to
support their claims that their products
were safe, effective, hypoallergenic, or
provided a certain sun protection factor
(SPF), including after exposure to water.
AMA customers that manufactured
sunscreens used the test results to
comply with FDA regulations requiring
sunscreen manufacturers to have their
products tested and to maintain the test
results for possible review by the FDA.
From 1987 to April 2017, Mr. Letizia
and AMA personnel operating at Mr.
Letizia’s direction, defrauded AMA’s
customers of more than $46 million by
testing products on materially lower
numbers of panelists than the numbers
specified and paid for by AMA’s
customers. At Mr. Letizia’s direction,
AMA personnel rarely tested products
on the number of panelists requested by
AMA’s customers and for which they
had paid. AMA’s fees for tests were
based, in part, on the number of
panelists that were to participate in the
study. However, at Mr. Letizia’s
direction AMA sent its customers
fraudulent test results, via interstate
email and facsimile communications, in
which AMA personnel included
fictitious data for ‘‘phantom’’ panelists
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who had not actually participated in the
tests. At Mr. Letizia’s direction, AMA
employees had panelists who agreed to
partake in studies at AMA fill out
consent forms and other paperwork as if
they would be participating in all of the
studies that were being performed at
AMA at that time. These panelists were
then used as ‘‘phantom’’ panelists in
other studies, and their consent forms
for those studies would falsely make it
appear to those who might audit AMA’s
files, including FDA investigators and
AMA’s customers, that the panelists had
participated in studies when, in fact,
they had not. In addition, AMA
customers who paid for AMA to test
their sunscreen products relied on the
reliability of AMA’s test results for
purposes of accurately and lawfully
labeling the SPF level of the sunscreen
products those customers intended to
sell. Mr. Letizia knowingly caused AMA
employees to send false reports to
AMA’s customers in that testing had not
been performed on the whole panel as
requested and paid for by AMA’s
customers. In so doing, Mr. Letizia
knowingly caused AMA’s customers to
market and sell to consumers in the
United States and elsewhere, sunscreen,
with labels that failed to reveal material
facts in that the labels on these products
stated that the SPF level of the
sunscreen was 50 with no indication on
that label that the laboratory testing of
the panel paid for by AMA customers
had not been performed.
In addition, at Mr. Letizia’s direction,
AMA personnel routinely falsified test
results relating to AMA’s customers’
products, which included suppressing
reports of adverse reactions and
deviating from testing protocols. AMA
personnel reported adverse reactions to
customers only in extreme cases and
often offered to retest the product and,
in some cases, change the test procedure
with the hope of reducing the number
of reported negative reactions. AMA
personnel also falsified data to accord
with prior results from smaller
‘‘screener’’ study results or customer
expectations.
Based on this conviction, FDA sent
Mr. Letizia by certified mail on
September 12, 2022, 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.
Letizia 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. Letizia an
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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 would
constitute an election not to use the
opportunity for a hearing and a waiver
of any contentions concerning this
action. Mr. Letizia received the proposal
on September 16, 2022. He did not
request a hearing within the timeframe
prescribed by regulation 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 Mr. Letizia 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,
Mr. Letizia is permanently debarred
from providing services in any capacity
to a person with an approved or
pending drug product application,
effective (see DATES) (see sections
306(a)(2)(B) and (c)(2)(A)(ii) 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 in any capacity the services of Mr.
Letizia 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. Letizia 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 application from Mr. Letizia during
his period of debarment, other than in
connection with an audit under section
306 of the FD&C Act (section
306(c)(1)(B) of the FD&C Act). Note that,
for purposes of sections 306 and 307 of
the FD&C Act, a ‘‘drug product’’ is
defined as a ‘‘drug subject to regulation
under section 505, 512, or 802 of this
Act [(21 U.S.C. 355, 360b, 382)] or under
section 351 of the Public Health Service
Act [(42 U.S.C. 262)]’’ (section 201(dd)
of the FD&C Act (21 U.S.C. 321(dd))).
Any application by Mr. Letizia for
special termination of debarment under
section 306(d)(4) of the FD&C Act)
should be identified with Docket No.
FDA–2022–N–1600 and sent to the
Dockets Management Staff (see
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Federal Register / Vol. 88, No. 11 / Wednesday, January 18, 2023 / Notices
ADDRESSES). The public availability of
information in these submissions is
governed by 21 CFR 10.20.
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, 240–402–7500.
Dated: January 11, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–00791 Filed 1–17–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–3071]
Joint Meeting of the Drug Safety and
Risk Management Advisory Committee
and the Dermatologic and Ophthalmic
Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Drug Safety and Risk
Management Advisory Committee and
the Dermatologic and Ophthalmic Drugs
Advisory Committee. The general
function of the committees is to provide
advice and recommendations to FDA on
regulatory issues. The meeting will be
open to the public. FDA is establishing
a docket for public comment on this
document.
DATES: The meeting will be held
virtually on March 28 and 29, 2023,
from 10 a.m. to 4 p.m. Eastern Time.
ADDRESSES: Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2022–N–3071.
Please note that late, untimely filed
comments will not be considered. The
docket will close on March 27, 2023.
The https://www.regulations.gov
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SUMMARY:
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electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 27, 2023. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are received
on or before that date.
Comments received on or before
March 14, 2023, will be provided to the
committees. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
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2022–N–3071 for ‘‘Joint Meeting of the
Drug Safety and Risk Management
Advisory Committee and the
Dermatologic and Ophthalmic Drugs
Advisory Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
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comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ FDA
will review this copy, including the
claimed confidential information, in its
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
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If you do not wish your name and
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information on the cover sheet and not
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must identify the information as
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as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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docket number, found in brackets in the
heading of this document, into the
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and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
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FOR FURTHER INFORMATION CONTACT:
Philip Bautista, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
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]]>Agencies
[Federal Register Volume 88, Number 11 (Wednesday, January 18, 2023)]
[Notices]
[Pages 2935-2937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00791]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1600]
Gabriel J. Letizia, Jr.: Final 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) permanently
debarring Gabriel J. Letizia, Jr. 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. Letizia 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. Letizia was given
notice of the proposed permanent debarment and was given an opportunity
to request a hearing to show why he should not be debarred within the
timeframe prescribed by regulation. Mr. Letizia has not responded to
the notice. Mr. Letizia's failure to respond and request a hearing
within the prescribed timeframe constitutes a waiver of his right to a
hearing concerning this action.
DATES: This order is applicable January 18, 2023.
ADDRESSES: Submit applications for special termination of debarment to
the Dockets Management Staff, Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Compliance
and Enforcement, Office of Policy, Compliance, and Enforcement, Office
of Regulatory Affairs, Food and Drug Administration, 240-402-8743, or
at [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
requires
[[Page 2936]]
debarment of an individual from providing services in any capacity to a
person that has an approved or pending drug product application 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 May 18, 2022, Mr. Letizia was convicted in the U.S.
District Court for the Southern District of New York, of one felony
count of conspiracy to commit wire fraud in violation of 18 U.S.C. 371,
and two misdemeanor counts of misbranding in violation of 21 U.S.C.
331(a) and 333(a)(1). FDA's finding that debarment is appropriate is
based on the felony conviction referenced herein.
The factual basis for this conviction is as follows: As contained
in the Superseding Information in Mr. Letizia's case, filed May 4,
2021, and from the transcript of his guilty plea hearing, filed on May
26, 2021, Mr. Letizia was the owner and executive director of AMA
Laboratories (AMA), a consumer product testing company in Rockland
County, New York. Mr. Letizia began operating AMA in the early 1980s
and became its sole owner in approximately 2003. Mr. Letizia falsely
used the title ``Dr.'' in correspondence, falsely representing to
customers that he held a Ph.D. AMA purported to test the safety and
efficacy of cosmetics, sunscreens, and other products on specified
numbers of volunteer panelists for consumer products companies. AMA's
customers would use the test results to support their claims that their
products were safe, effective, hypoallergenic, or provided a certain
sun protection factor (SPF), including after exposure to water. AMA
customers that manufactured sunscreens used the test results to comply
with FDA regulations requiring sunscreen manufacturers to have their
products tested and to maintain the test results for possible review by
the FDA.
From 1987 to April 2017, Mr. Letizia and AMA personnel operating at
Mr. Letizia's direction, defrauded AMA's customers of more than $46
million by testing products on materially lower numbers of panelists
than the numbers specified and paid for by AMA's customers. At Mr.
Letizia's direction, AMA personnel rarely tested products on the number
of panelists requested by AMA's customers and for which they had paid.
AMA's fees for tests were based, in part, on the number of panelists
that were to participate in the study. However, at Mr. Letizia's
direction AMA sent its customers fraudulent test results, via
interstate email and facsimile communications, in which AMA personnel
included fictitious data for ``phantom'' panelists who had not actually
participated in the tests. At Mr. Letizia's direction, AMA employees
had panelists who agreed to partake in studies at AMA fill out consent
forms and other paperwork as if they would be participating in all of
the studies that were being performed at AMA at that time. These
panelists were then used as ``phantom'' panelists in other studies, and
their consent forms for those studies would falsely make it appear to
those who might audit AMA's files, including FDA investigators and
AMA's customers, that the panelists had participated in studies when,
in fact, they had not. In addition, AMA customers who paid for AMA to
test their sunscreen products relied on the reliability of AMA's test
results for purposes of accurately and lawfully labeling the SPF level
of the sunscreen products those customers intended to sell. Mr. Letizia
knowingly caused AMA employees to send false reports to AMA's customers
in that testing had not been performed on the whole panel as requested
and paid for by AMA's customers. In so doing, Mr. Letizia knowingly
caused AMA's customers to market and sell to consumers in the United
States and elsewhere, sunscreen, with labels that failed to reveal
material facts in that the labels on these products stated that the SPF
level of the sunscreen was 50 with no indication on that label that the
laboratory testing of the panel paid for by AMA customers had not been
performed.
In addition, at Mr. Letizia's direction, AMA personnel routinely
falsified test results relating to AMA's customers' products, which
included suppressing reports of adverse reactions and deviating from
testing protocols. AMA personnel reported adverse reactions to
customers only in extreme cases and often offered to retest the product
and, in some cases, change the test procedure with the hope of reducing
the number of reported negative reactions. AMA personnel also falsified
data to accord with prior results from smaller ``screener'' study
results or customer expectations.
Based on this conviction, FDA sent Mr. Letizia by certified mail on
September 12, 2022, 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. Letizia 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. Letizia
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 would
constitute an election not to use the opportunity for a hearing and a
waiver of any contentions concerning this action. Mr. Letizia received
the proposal on September 16, 2022. He did not request a hearing within
the timeframe prescribed by regulation 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 Mr.
Letizia 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, Mr. Letizia is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application, effective (see DATES)
(see sections 306(a)(2)(B) and (c)(2)(A)(ii) 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 in any capacity the services of Mr. Letizia 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. Letizia 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
application from Mr. Letizia during his period of debarment, other than
in connection with an audit under section 306 of the FD&C Act (section
306(c)(1)(B) of the FD&C Act). Note that, for purposes of sections 306
and 307 of the FD&C Act, a ``drug product'' is defined as a ``drug
subject to regulation under section 505, 512, or 802 of this Act [(21
U.S.C. 355, 360b, 382)] or under section 351 of the Public Health
Service Act [(42 U.S.C. 262)]'' (section 201(dd) of the FD&C Act (21
U.S.C. 321(dd))).
Any application by Mr. Letizia for special termination of debarment
under section 306(d)(4) of the FD&C Act) should be identified with
Docket No. FDA-2022-N-1600 and sent to the Dockets Management Staff
(see
[[Page 2937]]
ADDRESSES). The public availability of information in these submissions
is governed by 21 CFR 10.20.
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, 240-402-7500.
Dated: January 11, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00791 Filed 1-17-23; 8:45 am]
BILLING CODE 4164-01-P
