John D. Noonan; Denial of Hearing; Final Debarment Order, 12007-12010 [2015-05042]
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BILLING CODE 4184–32–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0300]
John D. Noonan; Denial of Hearing;
Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is denying a
request for a hearing submitted by Dr.
John D. Noonan (Dr. Noonan), and is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) debarring Dr. Noonan for 2
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. Noonan was convicted
of a misdemeanor under Federal law for
conduct relating to the regulation of a
drug product under the FD&C Act and
that the type of conduct underlying the
conviction undermines the process for
the regulation of drugs. In determining
the appropriateness and period of Dr.
Noonan’s debarment, FDA has
considered the relevant factors listed in
the FD&C Act. Dr. Noonan has failed to
file with the Agency information and
analyses sufficient to create a basis for
a hearing concerning this action.
DATES: The order is effective March 5,
2015.
ADDRESSES: Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Nathan Doty, Office of Scientific
Integrity, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
796–8556.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
On August 11, 2009, in the U.S.
District Court for the Northern District
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of New York, Dr. Noonan, a physician,
pled guilty to a misdemeanor under the
FD&C Act, namely misbranding a drug
in violation of sections 301(k), 502(i)(3)
and 303(a)(1) of the FD&C Act (21 U.S.C.
331(k), 352(i)(3), 333(a)(1)) and 18
U.S.C. 2. The basis for this conviction
was conduct surrounding his injection
of patients seeking treatment with
BOTOX/BOTOX Cosmetic (BOTOX)
with a product, TRI-toxin, distributed
by Toxin Research International, Inc.
BOTOX is a biological product derived
from Botulinum Toxin Type A that is
manufactured by Allergan, Inc., and was
approved by FDA for use on humans for
the treatment of facial wrinkles in 1991.
According to the records of the criminal
proceedings, Dr. Noonan’s colleague in
the same medical practice, The Plastic
Surgery Group (TPSG), directed a nurse
to obtain 31 vials of TRI-toxin, an
unapproved drug product, which was
represented by its distributor as
‘‘Botulinum Toxin Type A.’’ Dr. Noonan
then proceeded to inject approximately
10 patients, who believed they were
being injected with BOTOX, with TRItoxin as a substitute.
Dr. Noonan is subject to debarment
based on a finding, under section
306(b)(2)(B)(i)(I) of the FD&C Act (21
U.S.C. 335a(b)(2)(B)(i)(I)): (1) That he
was convicted of a misdemeanor under
Federal law relating to the regulation of
a drug product under the FD&C Act and
(2) that the type of conduct underlying
the conviction undermines the process
for the regulation of drugs. By notice to
Dr. Noonan dated November 30, 2010,
FDA’s Office of Regulatory Affairs
(ORA) proposed to debar him for 4 years
from providing services in any capacity
to a person having an approved or
pending drug product application.
In a letter dated December 30, 2010,
through counsel, Dr. Noonan requested
a hearing on the proposal. In his request
for a hearing, Dr. Noonan acknowledges
his conviction under Federal law, as
alleged by FDA. By letter dated January
28, 2011, Dr. Noonan submitted
materials and arguments in support of
his request. Dr. Noonan acknowledges
that he was convicted of a Federal
misdemeanor, as found in the proposal
to debar, but argues that he should not
be debarred for reasons related to the
factual basis set forth in the proposal to
debar. In particular, with respect to the
considerations for determining the
appropriateness and period of
debarment under section 306(c)(3) of the
FD&C Act, he argues that there are
genuine and substantial issues of fact for
resolution at a hearing, namely factual
issues bearing on whether he
participated in or even knew of certain
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conduct that resulted in his violation of
the FD&C Act.
Hearings are granted only if there is
a genuine and substantial issue of fact.
Hearings will not be granted on issues
of policy or law, on mere allegations,
denials, or general descriptions of
positions and contentions, or on data
and information insufficient to justify
the factual determination urged or the
action requested (see 21 CFR 12.24(b)).
The Chief Scientist has considered Dr.
Noonan’s arguments, as well as the
proposal to debar itself, and concludes
that, although Dr. Noonan has failed to
raise a genuine and substantial issue of
fact requiring a hearing, the appropriate
period of debarment is 2 years.
II. Arguments
In support of his hearing request, Dr.
Noonan first asserts that he is not
subject to debarment under section
306(b)(2)(B)(i)(I) of the FD&C Act. He
contends that he pled guilty to a
misdemeanor violation of the FD&C Act
(see section 303(a)(1)), which is a strict
liability offense, and that thus there was
no demonstration or admission of
criminal intent or knowledge
underlying the conviction. Dr. Noonan
concludes, therefore, that the conduct
underlying his conviction did not
undermine the process for the
regulation of drugs.
Section 306(b)(2)(B)(i)(I) of the FD&C
Act specifically provides for the
debarment of individuals convicted of
Federal misdemeanors related to the
regulation of drug products under the
FD&C Act. Given that misdemeanor
violations of the FD&C Act themselves
are strict liability offenses, it stands to
reason that criminal intent is not a
critical component to debar an
individual under section
306(b)(2)(B)(i)(I). During his criminal
proceedings, Dr. Noonan pled guilty to
misbranding and causing the
misbranding of a drug in violation of
sections 301(k), 502(i)(3) and 303(a)(1)
of the FD&C Act by offering an
unapproved drug, TRI-toxin, for sale as
an approved drug product, BOTOX. Dr.
Noonan’s conduct undermined the
process for the regulation of drugs in
that it permitted an unapproved drug to
be substituted for an approved drug
without the knowledge of the patient.
As a result, Dr. Noonan is, in fact,
subject to debarment under section
306(b)(2)(B)(i)(I) of the FD&C Act.
Dr. Noonan next challenges the
manner in which ORA applied the
considerations under section 306(c)(3)
of the FD&C Act in determining the
appropriateness and period of his
debarment. In the proposal to debar Dr.
Noonan, ORA stated that there are four
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applicable considerations under section
306(c)(3) of the FD&C Act: (1) The
nature and seriousness of his offense
under section 306(c)(3)(A); (2) the
nature and extent of management
participation in the offense under
section 306(c)(3)(B); (3) the nature and
extent of voluntary steps taken to
mitigate the impact on the public under
section 306(c)(3)(C); and (4) prior
convictions involving matters within
the jurisdiction of FDA under section
306(c)(3)(F). ORA found with respect to
Dr. Noonan that the first two
considerations weigh in favor of
debarment and noted that the third and
fourth considerations would be treated
as favorable factors for him. In making
all of its findings under section 306(c)(3)
of the FD&C Act, ORA characterized Dr.
Noonan’s conduct based on records
from his criminal proceedings.
Under section 306(c)(3)(A) of the
FD&C Act, in determining the
appropriateness and period of
debarment, FDA considers ‘‘the nature
and seriousness of the offense
involved.’’ In the proposal to debar,
ORA relied on the criminal information
to which Dr. Noonan pled guilty to find
that the conduct underlying his
convictions:
created a risk of injury to consumers due to
the use of an unapproved drug, undermined
[FDA’s] oversight of an approved drug
product by representing that [he] used the
approved drug while actually substituting an
unapproved drug in its place, and seriously
undermined the integrity of [FDA’s]
regulation of drug products.
Under section 306(c)(3)(B) of the FD&C
Act, ORA also considered the ‘‘nature
and extent of [Dr. Noonan’s]
management participation in the
offense’’ and specifically found that he
was a corporate principal who ‘‘pleaded
guilty to misbranding TRI-toxin’’ and
‘‘participated in the [TPSG’s] unlawful
conduct of administering [an]
unapproved drug on multiple occasions
to patients.’’ ORA concluded, therefore,
that the nature and seriousness of
Noonan’s offenses and the nature and
extent of management participation
were unfavorable factors with respect to
him.
Dr. Noonan counters ORA’s findings
with respect to those two considerations
in section 306(c)(3) of the FD&C Act
with the following arguments: (1) That
he did not admit any criminal intent or
intentional wrongdoing when he pled
guilty to a misdemeanor offense under
the FD&C Act; (2) that, in fact, another
physician at TPSG took unilateral action
in ordering the TRI-toxin and directing
a nurse to substitute it for BOTOX; (3)
that the TRI-toxin vials that they used
for injecting patients with TRI-toxin
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were identical to the vials he used for
BOTOX before the substitution; and (4)
that since the conviction for the
underlying misdemeanor was of an
individual, that there was no
management participation and that,
thus, the nature and extent of
management participation is
inapplicable as a factor in determining
appropriateness and period of
debarment. Dr. Noonan concedes that he
pled guilty to the misdemeanor offense
because he was, in fact, guilty of
offering TRI-toxin for sale to their
patients as BOTOX. He argues, however,
that the criminal records do not
establish any intent or knowledge on his
part and that thus the conduct
underlying his conviction does not
warrant debarment in light of the
considerations in section 306(c)(3) of
the FD&C Act.
As noted previously, ORA relied on
the records of Dr. Noonan’s criminal
proceedings for its findings in the
proposal to debar. There is nothing
definitive in the criminal records before
FDA to contradict Dr. Noonan’s
assertions with respect to the nature of
his involvement in the misdemeanor
offense to which he pled guilty. The
criminal information to which Dr.
Noonan pled guilty alleges that TPSG,
as opposed to Dr. Noonan, began
ordering TRI-toxin for use in the
medical practice, and there are no
allegations that Dr. Noonan took part in
the ordering process. Indeed, the
proposal to debar states that, as claimed
by Dr. Noonan, another physician in the
practice, William F. DeLuca, Jr., was
responsible for authorizing a nurse to
substitute TRI-toxin for BOTOX, not Dr.
Noonan. At Dr. Noonan’s sentencing
hearing, at which six other
codefendants, including DeLuca, were
also sentenced, the presiding judge also
made clear that he believed DeLuca was
the physician responsible for making
the ‘‘mistake’’ that led to the other
physician’s offenses. In addressing
DeLuca, the court stated:
And we’re here because of your actions and
inactions. As I said, your mistakes were
different in kind and degree from those of
your colleagues. It was you who brought this
drug into the practice, and it was your
conduct and your failure to check out either
the company or the drug that you were
ordering, as you should have done, your
negligence in doing that that has brought us
here today in the end.
In addressing Dr. Noonan, the court
further stated: ‘‘There have been
disputes on how in the past over who
knew what and at what point in time.
It is clear from the facts in this case that
you had no knowledge that the
substance was anything other than
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[BOTOX] until your discovery of it in
November of 2004.’’
In short, consistent with the proposal
to debar Dr. Noonan for 4 years, the
records of his criminal proceedings
establish that the misdemeanor
convictions for the physicians in TPSG
other than DeLuca were not based on
any affirmative involvement in ordering
the TRI-toxin or substituting the TRItoxin for BOTOX. Furthermore, in
proposing to debar Dr. Noonan for 4
years, ORA did not rely on any findings
with respect to Dr. Noonan’s intent or
knowledge. Rather, citing the records of
Dr. Noonan’s criminal proceedings, the
proposal to debar simply rests on Dr.
Noonan’s position of authority within
TPSG and his conduct in misbranding
TRI-toxin by administering it to patients
who believed they were receiving
BOTOX. As a result, under § 12.24(b),
there is no genuine and substantial issue
of fact raised by Dr. Noonan’s arguments
for resolution at a hearing.
As set forth in the proposal to debar
and summarized previously, Dr. Noonan
pled guilty to a misdemeanor under the
FD&C Act for his role in offering a drug
under the name of another. Based on the
undisputed record before the Agency,
the consideration in section 306(c)(3)(A)
of the FD&C Act with respect to the
nature and seriousness of the offense
involved is a favorable factor. As
reflected in the records of the criminal
proceedings, Dr. Noonan’s offense did
not rest on any intent or knowledge of
wrongdoing on his part, nor may such
intent or knowledge be inferred from the
circumstances of his offense or the
findings in the proposal to debar.
Although, as a practicing physician, Dr.
Noonan should be expected to take the
appropriate steps to avoid administering
an unapproved new drug to patients or
misrepresenting the drug being
administered, his failure to do so over
a 10-month period does not warrant
considering the nature and seriousness
of his offense as an unfavorable factor,
relative to the range of conduct that
might underlie a Federal misdemeanor
conviction.
On the other hand, because of Dr.
Noonan’s position of authority within
TPSG and, thus, presumed ability to
prevent the series of events that resulted
in the offense underlying his
misdemeanor conviction, the nature and
extent of management participation in
the offense is an unfavorable factor, for
the purposes of the consideration under
306(c)(3)(B) of the FD&C Act. Dr.
Noonan asserts that there was no
management participation, and that,
thus, this factor is inapplicable because
the underlying conviction was of an
individual. However, the criminal
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information to which Dr. Noonan pled
guilty alleges that TPSG began ordering
TRI-toxin for use in the medical
practice. It is undisputed that Dr.
Noonan is a principal in TPSG, and this
is the basis for considering the nature
and extent of management participation
as a factor in determining the
appropriateness and period of
debarment. FDA has relied on this factor
in other debarment cases where the
underlying conviction was of an
individual (see 78 FR 68455 (November
14, 2013), 77 FR 27236 (May 9, 2012)).
The limited scope of his direct actions
in committing the underlying
misdemeanor offense does not mitigate
the extent of his management
participation, as established during his
criminal proceedings and as set out in
the proposal to debar. It is true that
nothing in the criminal proceedings or
the proposal to debar reflects any
involvement by him in the decision to
order the TRI-toxin and substitute it for
BOTOX, and the proposal to debar
specifically finds that another physician
authorized a nurse to place that order.
However, Dr. Noonan, as a principal of
TPSG, was responsible for failing to
ensure that there were controls and
procedures in place to prevent other
physicians or a nurse from ordering
unapproved drugs for administration to
patients. His own admitted inaction on
that front warrants treating his
management participation as an
unfavorable factor.1
Consistent with the proposal to debar,
the record establishes that the medical
practice of which Dr. Noonan was a part
ultimately took voluntary steps to
mitigate the effect on the public health
from its unlawful conduct (see section
306(c)(3)(C) of the FD&C Act).
Furthermore, it is undisputed that Dr.
Noonan had no previous criminal
convictions related to matters within the
jurisdiction of FDA (see section
306(c)(3)(F) of the FD&C Act). Therefore,
these will be treated as favorable factors.
In light of the foregoing four
considerations, one of which weighs
against Dr. Noonan, debarment for 2
years is appropriate.
III. Findings and Order
Therefore, the Chief Scientist, under
section 306(b)(2)(B)(i)(I) of the FD&C
Act and under authority delegated to
him, finds that Dr. Noonan has been
convicted of a misdemeanor under
Federal law for conduct relating to the
development or approval of a drug
1 See United States v. Park, 421 U.S. 658, 673–
74 (1975) (holding that a high-level manager within
a business entity bears a responsibility to prevent
and correct violations of the FD&C Act).
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product or otherwise relating to the
regulation of a drug product under the
FD&C Act and that the conduct
underlying the conviction undermines
the regulation of drugs. FDA has
considered the relevant factors listed in
section 306(c)(3) of the FD&C Act and
determined that a debarment of 2 years
is appropriate.
As a result of the foregoing findings,
Dr. Noonan is debarred for 2 years from
providing services in any capacity to a
person with an approved or pending
drug product application under section
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 21 U.S.C. 335a(c)(1)(B) and
(c)(2)(A)(iii) and 21 U.S.C. 321(dd)).
Any person with an approved, or
pending, drug product application, who
knowingly uses the services of Dr.
Noonan, in any capacity during his
period of debarment, will be subject to
civil money penalties. If Dr. Noonan,
during his period of debarment,
provides services in any capacity to a
person with an approved or pending
drug product application he will be
subject to civil money penalties. In
addition, FDA will not accept or review
any abbreviated new drug applications
submitted by or with the assistance of
Dr. Noonan during his period of
debarment.
Any application by Dr. Noonan for
termination of debarment under section
306(d) of the FD&C Act should be
identified with Docket No. FDA–2010–
N–0300 and sent to the Division of
Dockets Management (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 may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday. Persons with access to
the Internet may obtain documents in
the Docket at https://
www.regulations.gov/.
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Dated: February 24, 2015.
Stephen Ostroff,
Director, Office of the Chief Scientist.
[FR Doc. 2015–05042 Filed 3–4–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Clinical Outcomes Assessment
Development and Implementation:
Opportunities and Challenges; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Clinical Outcomes Assessment
Development and Implementation:
Opportunities and Challenges.’’ The
purpose of the public workshop is to
provide updates on accomplishments,
challenges, and ongoing efforts in the
use of clinical outcome assessments
(COAs), and plan for the future of COA
development and utilization in drug
development programs, including how
to incorporate the patient voice in drug
development using well-defined and
reliable patient-centered outcome
measures. The public workshop will
also discuss standards for COA use and
collaborative processes for COA
development and dissemination.
Date and Time: The public workshop
will be held on April 1, 2015, from 8:30
a.m. to 5 p.m. Participants are
encouraged to arrive early to ensure
time for parking and routine security
checks before the workshop.
Location: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, The Great Room
(Rm. 1503), Silver Spring, MD 20993–
0002. Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm. Attendees are
responsible for their own
accommodations.
The public workshop will also be
available to be viewed online via
Webcast at https://
collaboration.fda.gov/
COApublicworkshop2015. Persons
interested in participating by Webcast
must register online by March 27, 2015.
Contact Person: Michelle Campbell,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6471, Silver Spring,
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
MD 20993–0002, 240–402–6019, email:
COApublicworkshop@fda.hhs.gov.
Registration: Registration is free for
the public workshop. Interested parties
are encouraged to register early because
space is limited to 150 attendees.
Workshop space will be filled in order
of receipt of registration. Those accepted
in to the workshop will receive
confirmation. Registration will close
after the workshop is filled. Registration
at the site is not guaranteed but may be
possible on a space available basis on
the day of the public workshop
beginning at 7:30 a.m. If registration is
filled, attendance to the workshop will
be available only through the Webcast.
To register, visit https://www.fda.gov/
Drugs/NewsEvents/ucm431040.htm. For
those without Internet access, please
call Michelle Campbell (See Contact
Person) to register.
If you need special accommodations
due to a disability, please contact
Michelle Campbell (See Contact Person)
at least 7 days in advance.
SUPPLEMENTARY INFORMATION: The
Center for Drug Evaluation and Research
(CDER) reviews COAs, including
patient-reported outcome measures,
clinician-reported outcome measures,
and observer-reported outcome
measures, when submitted with an
investigational new drug application, a
new drug application, or a biologics
licensing application. CDER also
reviews a COA when submitted for
qualification as a drug development
tool. Qualification of a COA is a
regulatory determination that the COA
is well-suited for a specific context of
use in drug development. Following a
public announcement of the
qualification decision by FDA, the COA
will be publicly available for use in any
appropriate drug development program.
This workshop will focus on current
challenges and opportunities in COA
development and use, including
establishing appropriate standards for
use; current efforts to encourage
inclusion of well-defined and reliable
patient-centered outcome measures in
drug development; use of collaborative
efforts in developing and utilizing COAs
through various partnerships; and future
efforts to address challenges and gaps of
COA development and use for patientcentered drug development and medical
product labeling.
For more information on this public
workshop, visit https://www.fda.gov/
Drugs/NewsEvents/ucm431040.htm.
The Agency encourages patient
advocates, health care providers,
researchers, regulators, individuals from
academia, industry, and other interested
persons to attend this public workshop.
E:\FR\FM\05MRN1.SGM
05MRN1
Agencies
[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Notices]
[Pages 12007-12010]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05042]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0300]
John D. Noonan; Denial of Hearing; Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is denying a request
for a hearing submitted by Dr. John D. Noonan (Dr. Noonan), and is
issuing an order under the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) debarring Dr. Noonan for 2 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. Noonan was
convicted of a misdemeanor under Federal law for conduct relating to
the regulation of a drug product under the FD&C Act and that the type
of conduct underlying the conviction undermines the process for the
regulation of drugs. In determining the appropriateness and period of
Dr. Noonan's debarment, FDA has considered the relevant factors listed
in the FD&C Act. Dr. Noonan has failed to file with the Agency
information and analyses sufficient to create a basis for a hearing
concerning this action.
DATES: The order is effective March 5, 2015.
ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Nathan Doty, Office of Scientific
Integrity, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, 301-796-8556.
SUPPLEMENTARY INFORMATION:
I. Background
On August 11, 2009, in the U.S. District Court for the Northern
District
[[Page 12008]]
of New York, Dr. Noonan, a physician, pled guilty to a misdemeanor
under the FD&C Act, namely misbranding a drug in violation of sections
301(k), 502(i)(3) and 303(a)(1) of the FD&C Act (21 U.S.C. 331(k),
352(i)(3), 333(a)(1)) and 18 U.S.C. 2. The basis for this conviction
was conduct surrounding his injection of patients seeking treatment
with BOTOX/BOTOX Cosmetic (BOTOX) with a product, TRI-toxin,
distributed by Toxin Research International, Inc. BOTOX is a biological
product derived from Botulinum Toxin Type A that is manufactured by
Allergan, Inc., and was approved by FDA for use on humans for the
treatment of facial wrinkles in 1991. According to the records of the
criminal proceedings, Dr. Noonan's colleague in the same medical
practice, The Plastic Surgery Group (TPSG), directed a nurse to obtain
31 vials of TRI-toxin, an unapproved drug product, which was
represented by its distributor as ``Botulinum Toxin Type A.'' Dr.
Noonan then proceeded to inject approximately 10 patients, who believed
they were being injected with BOTOX, with TRI-toxin as a substitute.
Dr. Noonan is subject to debarment based on a finding, under
section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)): (1) That he was convicted of a misdemeanor under
Federal law relating to the regulation of a drug product under the FD&C
Act and (2) that the type of conduct underlying the conviction
undermines the process for the regulation of drugs. By notice to Dr.
Noonan dated November 30, 2010, FDA's Office of Regulatory Affairs
(ORA) proposed to debar him for 4 years from providing services in any
capacity to a person having an approved or pending drug product
application.
In a letter dated December 30, 2010, through counsel, Dr. Noonan
requested a hearing on the proposal. In his request for a hearing, Dr.
Noonan acknowledges his conviction under Federal law, as alleged by
FDA. By letter dated January 28, 2011, Dr. Noonan submitted materials
and arguments in support of his request. Dr. Noonan acknowledges that
he was convicted of a Federal misdemeanor, as found in the proposal to
debar, but argues that he should not be debarred for reasons related to
the factual basis set forth in the proposal to debar. In particular,
with respect to the considerations for determining the appropriateness
and period of debarment under section 306(c)(3) of the FD&C Act, he
argues that there are genuine and substantial issues of fact for
resolution at a hearing, namely factual issues bearing on whether he
participated in or even knew of certain conduct that resulted in his
violation of the FD&C Act.
Hearings are granted only if there is a genuine and substantial
issue of fact. Hearings will not be granted on issues of policy or law,
on mere allegations, denials, or general descriptions of positions and
contentions, or on data and information insufficient to justify the
factual determination urged or the action requested (see 21 CFR
12.24(b)).
The Chief Scientist has considered Dr. Noonan's arguments, as well
as the proposal to debar itself, and concludes that, although Dr.
Noonan has failed to raise a genuine and substantial issue of fact
requiring a hearing, the appropriate period of debarment is 2 years.
II. Arguments
In support of his hearing request, Dr. Noonan first asserts that he
is not subject to debarment under section 306(b)(2)(B)(i)(I) of the
FD&C Act. He contends that he pled guilty to a misdemeanor violation of
the FD&C Act (see section 303(a)(1)), which is a strict liability
offense, and that thus there was no demonstration or admission of
criminal intent or knowledge underlying the conviction. Dr. Noonan
concludes, therefore, that the conduct underlying his conviction did
not undermine the process for the regulation of drugs.
Section 306(b)(2)(B)(i)(I) of the FD&C Act specifically provides
for the debarment of individuals convicted of Federal misdemeanors
related to the regulation of drug products under the FD&C Act. Given
that misdemeanor violations of the FD&C Act themselves are strict
liability offenses, it stands to reason that criminal intent is not a
critical component to debar an individual under section
306(b)(2)(B)(i)(I). During his criminal proceedings, Dr. Noonan pled
guilty to misbranding and causing the misbranding of a drug in
violation of sections 301(k), 502(i)(3) and 303(a)(1) of the FD&C Act
by offering an unapproved drug, TRI-toxin, for sale as an approved drug
product, BOTOX. Dr. Noonan's conduct undermined the process for the
regulation of drugs in that it permitted an unapproved drug to be
substituted for an approved drug without the knowledge of the patient.
As a result, Dr. Noonan is, in fact, subject to debarment under section
306(b)(2)(B)(i)(I) of the FD&C Act.
Dr. Noonan next challenges the manner in which ORA applied the
considerations under section 306(c)(3) of the FD&C Act in determining
the appropriateness and period of his debarment. In the proposal to
debar Dr. Noonan, ORA stated that there are four applicable
considerations under section 306(c)(3) of the FD&C Act: (1) The nature
and seriousness of his offense under section 306(c)(3)(A); (2) the
nature and extent of management participation in the offense under
section 306(c)(3)(B); (3) the nature and extent of voluntary steps
taken to mitigate the impact on the public under section 306(c)(3)(C);
and (4) prior convictions involving matters within the jurisdiction of
FDA under section 306(c)(3)(F). ORA found with respect to Dr. Noonan
that the first two considerations weigh in favor of debarment and noted
that the third and fourth considerations would be treated as favorable
factors for him. In making all of its findings under section 306(c)(3)
of the FD&C Act, ORA characterized Dr. Noonan's conduct based on
records from his criminal proceedings.
Under section 306(c)(3)(A) of the FD&C Act, in determining the
appropriateness and period of debarment, FDA considers ``the nature and
seriousness of the offense involved.'' In the proposal to debar, ORA
relied on the criminal information to which Dr. Noonan pled guilty to
find that the conduct underlying his convictions:
created a risk of injury to consumers due to the use of an
unapproved drug, undermined [FDA's] oversight of an approved drug
product by representing that [he] used the approved drug while
actually substituting an unapproved drug in its place, and seriously
undermined the integrity of [FDA's] regulation of drug products.
Under section 306(c)(3)(B) of the FD&C Act, ORA also considered the
``nature and extent of [Dr. Noonan's] management participation in the
offense'' and specifically found that he was a corporate principal who
``pleaded guilty to misbranding TRI-toxin'' and ``participated in the
[TPSG's] unlawful conduct of administering [an] unapproved drug on
multiple occasions to patients.'' ORA concluded, therefore, that the
nature and seriousness of Noonan's offenses and the nature and extent
of management participation were unfavorable factors with respect to
him.
Dr. Noonan counters ORA's findings with respect to those two
considerations in section 306(c)(3) of the FD&C Act with the following
arguments: (1) That he did not admit any criminal intent or intentional
wrongdoing when he pled guilty to a misdemeanor offense under the FD&C
Act; (2) that, in fact, another physician at TPSG took unilateral
action in ordering the TRI-toxin and directing a nurse to substitute it
for BOTOX; (3) that the TRI-toxin vials that they used for injecting
patients with TRI-toxin
[[Page 12009]]
were identical to the vials he used for BOTOX before the substitution;
and (4) that since the conviction for the underlying misdemeanor was of
an individual, that there was no management participation and that,
thus, the nature and extent of management participation is inapplicable
as a factor in determining appropriateness and period of debarment. Dr.
Noonan concedes that he pled guilty to the misdemeanor offense because
he was, in fact, guilty of offering TRI-toxin for sale to their
patients as BOTOX. He argues, however, that the criminal records do not
establish any intent or knowledge on his part and that thus the conduct
underlying his conviction does not warrant debarment in light of the
considerations in section 306(c)(3) of the FD&C Act.
As noted previously, ORA relied on the records of Dr. Noonan's
criminal proceedings for its findings in the proposal to debar. There
is nothing definitive in the criminal records before FDA to contradict
Dr. Noonan's assertions with respect to the nature of his involvement
in the misdemeanor offense to which he pled guilty. The criminal
information to which Dr. Noonan pled guilty alleges that TPSG, as
opposed to Dr. Noonan, began ordering TRI-toxin for use in the medical
practice, and there are no allegations that Dr. Noonan took part in the
ordering process. Indeed, the proposal to debar states that, as claimed
by Dr. Noonan, another physician in the practice, William F. DeLuca,
Jr., was responsible for authorizing a nurse to substitute TRI-toxin
for BOTOX, not Dr. Noonan. At Dr. Noonan's sentencing hearing, at which
six other codefendants, including DeLuca, were also sentenced, the
presiding judge also made clear that he believed DeLuca was the
physician responsible for making the ``mistake'' that led to the other
physician's offenses. In addressing DeLuca, the court stated:
And we're here because of your actions and inactions. As I said,
your mistakes were different in kind and degree from those of your
colleagues. It was you who brought this drug into the practice, and
it was your conduct and your failure to check out either the company
or the drug that you were ordering, as you should have done, your
negligence in doing that that has brought us here today in the end.
In addressing Dr. Noonan, the court further stated: ``There have been
disputes on how in the past over who knew what and at what point in
time. It is clear from the facts in this case that you had no knowledge
that the substance was anything other than [BOTOX] until your discovery
of it in November of 2004.''
In short, consistent with the proposal to debar Dr. Noonan for 4
years, the records of his criminal proceedings establish that the
misdemeanor convictions for the physicians in TPSG other than DeLuca
were not based on any affirmative involvement in ordering the TRI-toxin
or substituting the TRI-toxin for BOTOX. Furthermore, in proposing to
debar Dr. Noonan for 4 years, ORA did not rely on any findings with
respect to Dr. Noonan's intent or knowledge. Rather, citing the records
of Dr. Noonan's criminal proceedings, the proposal to debar simply
rests on Dr. Noonan's position of authority within TPSG and his conduct
in misbranding TRI-toxin by administering it to patients who believed
they were receiving BOTOX. As a result, under Sec. 12.24(b), there is
no genuine and substantial issue of fact raised by Dr. Noonan's
arguments for resolution at a hearing.
As set forth in the proposal to debar and summarized previously,
Dr. Noonan pled guilty to a misdemeanor under the FD&C Act for his role
in offering a drug under the name of another. Based on the undisputed
record before the Agency, the consideration in section 306(c)(3)(A) of
the FD&C Act with respect to the nature and seriousness of the offense
involved is a favorable factor. As reflected in the records of the
criminal proceedings, Dr. Noonan's offense did not rest on any intent
or knowledge of wrongdoing on his part, nor may such intent or
knowledge be inferred from the circumstances of his offense or the
findings in the proposal to debar. Although, as a practicing physician,
Dr. Noonan should be expected to take the appropriate steps to avoid
administering an unapproved new drug to patients or misrepresenting the
drug being administered, his failure to do so over a 10-month period
does not warrant considering the nature and seriousness of his offense
as an unfavorable factor, relative to the range of conduct that might
underlie a Federal misdemeanor conviction.
On the other hand, because of Dr. Noonan's position of authority
within TPSG and, thus, presumed ability to prevent the series of events
that resulted in the offense underlying his misdemeanor conviction, the
nature and extent of management participation in the offense is an
unfavorable factor, for the purposes of the consideration under
306(c)(3)(B) of the FD&C Act. Dr. Noonan asserts that there was no
management participation, and that, thus, this factor is inapplicable
because the underlying conviction was of an individual. However, the
criminal information to which Dr. Noonan pled guilty alleges that TPSG
began ordering TRI-toxin for use in the medical practice. It is
undisputed that Dr. Noonan is a principal in TPSG, and this is the
basis for considering the nature and extent of management participation
as a factor in determining the appropriateness and period of debarment.
FDA has relied on this factor in other debarment cases where the
underlying conviction was of an individual (see 78 FR 68455 (November
14, 2013), 77 FR 27236 (May 9, 2012)).
The limited scope of his direct actions in committing the
underlying misdemeanor offense does not mitigate the extent of his
management participation, as established during his criminal
proceedings and as set out in the proposal to debar. It is true that
nothing in the criminal proceedings or the proposal to debar reflects
any involvement by him in the decision to order the TRI-toxin and
substitute it for BOTOX, and the proposal to debar specifically finds
that another physician authorized a nurse to place that order. However,
Dr. Noonan, as a principal of TPSG, was responsible for failing to
ensure that there were controls and procedures in place to prevent
other physicians or a nurse from ordering unapproved drugs for
administration to patients. His own admitted inaction on that front
warrants treating his management participation as an unfavorable
factor.\1\
---------------------------------------------------------------------------
\1\ See United States v. Park, 421 U.S. 658, 673-74 (1975)
(holding that a high-level manager within a business entity bears a
responsibility to prevent and correct violations of the FD&C Act).
---------------------------------------------------------------------------
Consistent with the proposal to debar, the record establishes that
the medical practice of which Dr. Noonan was a part ultimately took
voluntary steps to mitigate the effect on the public health from its
unlawful conduct (see section 306(c)(3)(C) of the FD&C Act).
Furthermore, it is undisputed that Dr. Noonan had no previous criminal
convictions related to matters within the jurisdiction of FDA (see
section 306(c)(3)(F) of the FD&C Act). Therefore, these will be treated
as favorable factors. In light of the foregoing four considerations,
one of which weighs against Dr. Noonan, debarment for 2 years is
appropriate.
III. Findings and Order
Therefore, the Chief Scientist, under section 306(b)(2)(B)(i)(I) of
the FD&C Act and under authority delegated to him, finds that Dr.
Noonan has been convicted of a misdemeanor under Federal law for
conduct relating to the development or approval of a drug
[[Page 12010]]
product or otherwise relating to the regulation of a drug product under
the FD&C Act and that the conduct underlying the conviction undermines
the regulation of drugs. FDA has considered the relevant factors listed
in section 306(c)(3) of the FD&C Act and determined that a debarment of
2 years is appropriate.
As a result of the foregoing findings, Dr. Noonan is debarred for 2
years from providing services in any capacity to a person with an
approved or pending drug product application under section 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 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) and 21 U.S.C. 321(dd)).
Any person with an approved, or pending, drug product application, who
knowingly uses the services of Dr. Noonan, in any capacity during his
period of debarment, will be subject to civil money penalties. If Dr.
Noonan, during his period of debarment, provides services in any
capacity to a person with an approved or pending drug product
application he will be subject to civil money penalties. In addition,
FDA will not accept or review any abbreviated new drug applications
submitted by or with the assistance of Dr. Noonan during his period of
debarment.
Any application by Dr. Noonan for termination of debarment under
section 306(d) of the FD&C Act should be identified with Docket No.
FDA-2010-N-0300 and sent to the Division of Dockets Management (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 may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday. Persons with access to the Internet may obtain
documents in the Docket at https://www.regulations.gov/.
Dated: February 24, 2015.
Stephen Ostroff,
Director, Office of the Chief Scientist.
[FR Doc. 2015-05042 Filed 3-4-15; 8:45 am]
BILLING CODE 4164-01-P