Timothy Baxter; Denial of Hearing; Final Debarment Order, 12369-12374 [2023-03946]
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Federal Register / Vol. 88, No. 38 / Monday, February 27, 2023 / Notices
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0028]
Timothy Baxter; Denial of Hearing;
Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
denying a request for a hearing
submitted by Dr. Timothy Baxter (Dr.
Baxter) and is issuing an order under
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) debarring Dr. Baxter for
5 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. Baxter 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.
Baxter’s debarment, FDA has considered
the applicable factors listed in the FD&C
Act. Dr. Baxter 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 applicable February
27, 2023.
ADDRESSES: Any application for
termination of debarment by Dr. Baxter
under section 306(d) of the FD&C Act
(21 U.S.C. 335a(d)) (application) may be
submitted as follows:
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Rachael Vieder Linowes, Office of
Scientific Integrity, Food and Drug
Administration, Rachael.Linowes@
fda.hhs.gov, 240–402–5931.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(2)(B)(i)(I) of the FD&C
Act permits FDA to debar an individual
if it finds that: (1) the individual has
been convicted of a misdemeanor under
Federal law ‘‘for conduct relating to the
development or approval, including the
process for development or approval, of
any drug product or otherwise relating
to the regulation of drug products’’
under the FD&C Act and (2) the type of
conduct that served as the basis for the
conviction undermines the process for
the regulation of drugs.
On August 31, 2020, in the U.S.
District Court for the Western District of
Virginia, Dr. Baxter pled guilty to a
misdemeanor violation of the FD&C Act.
Specifically, he pled guilty to causing
the introduction or delivery for
introduction of a misbranded drug into
interstate commerce in violation of
sections 301(a), 303(a)(1), and 502(a) of
the FD&C Act (21 U.S.C. 331(a),
333(a)(1), and 352(a)). In the plea
agreement pursuant to which Dr. Baxter
pled guilty, he agreed that ‘‘all the facts
set forth in the Information [filed by the
Federal government on the same day]
are true and correct and provide the
Court with a sufficient factual basis to
support [his] plea.’’ The Information
provided that, at the time of the conduct
underlying his conviction, Dr. Baxter
was the Global Medical Director of
Reckitt Benckiser Pharmaceuticals Inc.
(RBP).’’ 1 During that time, according to
the Information, RBP’s Medical Affairs
Manager, who reported directly to Dr.
Baxter, provided false or misleading
analysis and charts to the Massachusetts
Medicaid program (MassHealth), as a
means of persuading MassHealth to
1 As noted in the Information, ‘‘on or about
December 23, 2014, RBP was renamed Indivior, Inc,
and became a subsidiary of Indivior PLC. After on
or about December 23, 2014, Dr. Baxter was the
Chief Medical Officer of Indivior PLC.’’
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reimburse patients for a drug named
Suboxone Film, which RBP marketed.
As framed by the Information, the
false and misleading data and analysis
provided to MassHealth—relating to the
unintended pediatric exposure rates for
Suboxone Film relative to similar tablet
products—constituted ‘‘labeling’’ for the
drug under section 201(m) of the FD&C
Act (21 U.S.C. 321(m)) and thus
misbranded the drug under section
502(a) of the FD&C Act). As discussed
further below, in pleading guilty
pursuant to the Information, Dr. Baxter
conceded that he was a responsible
corporate officer (RCO) at RBP that
‘‘failed to prevent and promptly correct
the distribution of false and misleading
unintended pediatric exposure data and
marketing claims to MassHealth’’ and
‘‘caused the introduction and delivery
for introduction into interstate
commerce of . . . a drug [(Suboxone
Film)] that was misbranded in that the
drug’s labeling was false and
misleading’’ (see United States v. Park,
421 U.S. 658, 673–74 (1975)).
By letter dated February 25, 2021,
FDA’s Office of Regulatory Affairs
(ORA) notified Dr. Baxter of its proposal
to debar him for 5 years from providing
services in any capacity to a person
having an approved or pending drug
product application and provided him
with an opportunity to request a hearing
on the proposal. ORA found that Dr.
Baxter is subject to debarment under
section 306(b)(2)(B)(i)(I) of the FD&C
Act on the basis of his misdemeanor
conviction under Federal law for
conduct both relating to the regulation
of a drug product under the FD&C Act
and undermining the Agency’s process
for regulating drugs. The proposal also
outlined findings concerning the factors
ORA considered to be applicable in
determining the appropriateness and
period of debarment, as provided in
section 306(c)(3) of the FD&C Act. ORA
found that a 5-year period of debarment
is appropriate. Specifically, ORA found
that the nature and seriousness of the
offense and the nature and extent of
voluntary steps to mitigate the effect on
the public are unfavorable factors for Dr.
Baxter. ORA stated that it viewed the
absence of prior convictions involving
matters within FDA’s jurisdiction as a
favorable factor. ORA concluded that
‘‘the facts supporting the unfavorable
factors outweigh those supporting the
favorable factor and therefore warrant
the imposition of a 5-year period of
debarment.’’
By letter dated March 26, 2021,
through counsel, Dr. Baxter requested a
hearing on ORA’s proposal to debar
him. On May 4, 2021, he submitted a
‘‘Memorandum of Facts and Arguments
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in Support of Hearing Request’’
(Memorandum). In this Memorandum,
Dr. Baxter makes legal, factual, and
policy-based arguments regarding the
proffered basis for his debarment in
ORA’s proposal.
Under the authority delegated to her
by the Commissioner of Food and
Drugs, the Chief Scientist has
considered Dr. Baxter’s request for a
hearing. Hearings are granted only if
there is a genuine and substantial issue
of fact. As discussed in more detail
below, hearings will not be granted on
issues of policy or law, on mere
allegations, on denials or general
descriptions of positions and
contentions, on data and information
insufficient to justify the factual
determination urged if accurate and
presented at a hearing, or on factual
issues that are not determinative with
respect to the action requested (see
§ 12.24(b) (21 CFR 12.24(b))). The Chief
Scientist has considered Dr. Baxter’s
arguments and concluded that they are
unpersuasive and fail to raise a genuine
and substantial issue of fact requiring a
hearing.
II. Arguments
In his Memorandum, Dr. Baxter
makes a series of legal and policy
arguments challenging whether he is
subject to debarment and, if so, whether
debarment for 5 years is appropriate.
Many of Dr. Baxter’s arguments are
intertwined with his efforts to raise a
genuine and substantial issue of fact
with respect to the findings in ORA’s
proposal to debar him. Dr. Baxter’s legal
and factual arguments largely turn on
the extent to which the specific conduct
underlying his conviction subjects him
to debarment under section
306(b)(2)(B)(i) of the FD&C Act and the
extent to which there are genuine and
substantial issues of fact with respect to
ORA’s findings under section
306(b)(2)(B)(i) and the applicable
considerations under section 306(c)(3).
In challenging the facts underlying
ORA’s findings and the proposed period
of debarment, Dr. Baxter contends that
some of the findings in ORA’s proposal
go beyond the facts to which he
admitted during the criminal
proceedings and are demonstrably false.
Specifically, he disputes ORA’s
proposed findings: (1) that he ‘‘helped
oversee [RBP’s] efforts to secure
formulary coverage for Suboxone Film
from [MassHealth]’’ and a strategy to
that end; (2) that his misdemeanor
offense involved the provision of false
and misleading information to
MassHealth that included ‘‘overstated
safety claims’’; (3) that the conduct
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underlying his conviction ‘‘put children
at risk.’’
In challenging those proposed
findings, Dr. Baxter argues extensively
that he is entitled to a hearing because
not only are there genuine and
substantial issues of fact with respect to
them but they are conclusory and do not
appear to rest on substantial evidence.
He effectively contends, therefore, that
he is entitled to a hearing on those
findings for further development and an
opportunity to challenge them.
However, nothing in the relevant FDA
regulations, section 306(i) of the FD&C
Act, or the Administrative Procedure
Act (APA) (5 U.S.C. 551–559) requires
more than an opportunity to raise
genuine and substantial issues of fact
with respect to the findings in ORA’s
proposal. As Dr. Baxter notes, section
306(i) of the FD&C Act requires FDA to
provide an ‘‘opportunity for an agency
hearing on disputed issues of material
fact’’ before debarring any person. As
noted by ORA in its proposal, FDA
implements adjudications required
under section 5 U.S.C. 554(a), including
debarment matters, as formal
evidentiary hearings under part 12 (21
CFR part 12).
Under § 12.24(b), consistent with the
APA and case law, there are criteria for
granting a hearing. Pursuant to that
regulation, the Agency will grant a
request for hearing only if the material
submitted in support of the hearing
request shows, in relevant part: (1)
‘‘[t]here is a genuine and substantial
factual issue for resolution at a hearing,’’
(2) ‘‘[t]he factual issue can be resolved
by available and specifically identified
reliable evidence,’’ (3) ‘‘[t]he data and
information submitted, if established at
a hearing, would be adequate to justify
resolution of the factual issue in the way
sought by the person,’’ and (4)
‘‘[r]esolution of the factual issue in the
way sought by the person is adequate to
justify the action requested.’’ The
regulation further clarifies that ‘‘[a]
hearing will not be granted on issues of
policy or law’’ and that ‘‘a hearing will
not be granted on factual issues that are
not determinative with respect to the
action requested.’’
The factual challenges in Dr. Baxter’s
Memorandum, such as whether his
conduct put children at risk, do not
justify granting his hearing request. Dr.
Baxter appears to acknowledge, as he
must, that the facts to which he pled
guilty—i.e., the findings of the court that
entered a criminal judgment against
him—are not in dispute. Dr. Baxter’s
arguments highlighting those findings
by ORA that go beyond the facts to
which he admitted as part of his guilty
plea do not create a genuine and
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substantial issue of fact, nor are those
findings determinative with respect to
whether Dr. Baxter is subject to
debarment and whether a debarment
period of 5 years is appropriate. For
reasons discussed in detail below, it is
not necessary to go beyond the facts to
which Dr. Baxter pled guilty and the
other undisputed facts in ORA’s
proposal to conclude that Dr. Baxter is
subject to debarment under section
306(b)(2)(B)(i) of the FD&C Act and that
debarment for 5 years is appropriate
under section 306(c)(3).
For the sake of simplicity and
efficiency, what follows is an
assessment of Dr. Baxter’s legal, factual,
and policy-based arguments by
reference only to the facts to which he
pled guilty or the other undisputed
findings in ORA’s proposal.
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A. Dr. Baxter Is Subject to Debarment
Dr. Baxter first argues that he is not
subject to debarment under section
306(b)(2)(B)(i) of the FD&C Act. Dr.
Baxter maintains that a misdemeanor
conviction for causing the introduction
of a misbranded drug into interstate
commerce under the Responsible
Corporate Officer (RCO) doctrine is ‘‘not
sufficient to impose debarment’’ and
that his criminal conduct lacks a
sufficient nexus to ‘‘the regulation of
drug products’’ under the FD&C Act. Dr.
Baxter contends that his conduct does
not undermine the process for the
regulation of drugs and that, because the
drug product at issue had already
received FDA approval, the misleading
communication at issue did not relate to
the approval or the approval process. In
support of these arguments, he points to
the legislative history of section 306 of
the FD&C Act:
As the House Report to H.R. 2454 explains,
this section ‘‘gives FDA the authority to
debar a person . . . for conduct relating to
the development or approval of generic
drugs.’’ In addition ‘‘[c]onviction of certain
other crimes, such as bribery, fraud, and
obstruction of justice, could also be the basis
for debarment’’ because the seriousness of
those crimes undermines the trustworthiness
of the individual, such a conviction
‘‘provide[s] evidentiary support for a finding
that the individual should not be allowed to
submit or assist in the submission of a
generic drug application even though the
crime did not directly involve the approval
process’’ [emphasis removed]. Thus, there is
no indication that Congress intended to make
any conviction under Title 21 grounds for
permissive debarment, regardless of whether
or not the conduct had anything to do with
the drug approval process or fraud or
similarly serious offenses.
Dr. Baxter contends that ‘‘the
legislative history makes clear that
conduct that ‘undermines the process
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for the regulation of drugs’ is conduct
that either undermines the approval
process itself or constitutes such
egregious fraud that it supports the
conclusion that the individual can never
be trusted to participate in the
pharmaceutical industry’’ (emphases
removed). Finally, Dr. Baxter argues that
ORA’s finding that his conduct was of
a type that undermines the process for
the regulation of drugs is unsupported
because, while it was ‘‘technical
misbranding,’’ there was never any
harm or risk to the public.
Section 306(b)(2)(B)(i) of the FD&C
Act specifically provides for debarring
individuals convicted of Federal
misdemeanors related to the regulation
of drug products. If the language of the
statute is clear, there is no need to look
outside the statute to its legislative
history in order to ascertain the statute’s
meaning (Chamber of Commerce of
United States v. Whiting, 563 U.S. 582,
599 (2011)). Furthermore, as the
Supreme Court has repeatedly held, the
language in the FD&C Act should be
construed in a manner that is consistent
with its overall public health purpose.
When we are dealing with the public
health, the language of the FD&C Act
should not be read too restrictively, but
rather as ‘‘consistent with the Act’s
overriding purpose to protect the public
health’’ (United States v. Article of Drug
Bacto-Unidisk, 394 U.S. 784, 798
(1969)).
Dr. Baxter’s general argument that the
conduct underlying his conviction lacks
a sufficient nexus to the regulation of
drugs to subject him to debarment under
section 306(b)(2)(B)(i)(I) of the FD&C
Act lacks merit. Simply put, he pled
guilty to causing the introduction of a
misbranded drug into interstate
commerce in violation of the FD&C Act
(specifically, sections 301(a), 303(a)(1),
and 502(a) of the FD&C Act). In section
306(b)(2)(B)(i)(I), ‘‘a misdemeanor under
Federal law or a felony under State law
for conduct . . . otherwise relating to
the regulation of drug products’’
subjects an individual to permissive
debarment. There are no genuine and
substantial issues of fact regarding
whether Dr. Baxter pled guilty to—and
therefore committed—a misdemeanor
under Federal law. When that Federal
misdemeanor is for conduct that
directly violated the FD&C Act with
respect to drug labeling, there is no
question that such violation relates to
the regulation of drugs under that
statutory authority.
Dr. Baxter makes many similar
arguments with respect to whether the
conduct to which he pled guilty as part
of his misdemeanor plea is ‘‘the type of
conduct [that] . . . undermines the
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process for the regulation of drugs’’
under the FD&C Act in the sense
contemplated by section
306(b)(2)(B)(i)(I) of the FD&C Act. In
doing so, he attempts to distinguish
between conduct relating to the
development and approval process for
drug products and conduct relating to
other aspects of drug regulation under
the FD&C Act. Although he supports
that distinction by pointing to the
legislative history of section 306 and
offering policy arguments, neither
section 306(b)(2)(B)(i)(I) nor the FD&C
Act as a whole bear out that distinction.
The plain language of section
306(b)(2)(B)(i)(I) does not draw the
distinction urged by Dr. Baxter and
indeed expands the scope of the
statutory provision beyond conduct
relating to the development and
approval process by including the
language ‘‘otherwise relating to the
regulation of drug products.’’ With
respect to the purpose of FD&C Act as
a whole, the Supreme Court has found
that its aims go well beyond the
development and approval process for
drug products: ‘‘Its purpose [is] to
safeguard the consumer by applying the
Act to articles from the moment of their
introduction into interstate commerce
all the way to the moment of their
delivery to the ultimate consumer’’
(United States v. Sullivan, 332 U.S. 689,
696 (1948)).
The Chief Scientist also rejects Dr.
Baxter’s further arguments that he is not
subject to debarment under section
306(b)(2)(B)(i)(I) of the FD&C Act
because he pled guilty to a Federal
misdemeanor offense without admitting
any intent to violate the law or
knowledge of wrongdoing and because
the underlying offense did not involve
‘‘fraud, bribery, [or] similar crimes.’’
Given that section 306(b)(2)(B)(i) of the
FD&C Act explicitly permits debarring
individuals convicted of Federal
misdemeanors related to the regulation
of drug products and that a
misdemeanor violation of the FD&C Act
itself is a strict liability offense under
section 303(a)(1) of the FD&C Act, it
stands to reason that criminal intent is
not required to subject an individual to
debarment under section
306(b)(2)(B)(i)(I). As ORA correctly
determined, however, his conduct went
beyond a mere technical violation of the
FD&C Act:
[Dr. Baxter’s] actions undermined the
process for the regulation of drugs because
[he] failed to prevent [RBC] from sending
false and misleading data and information to
MassHealth related to the rate of unintended
pediatric exposure to Suboxone Film and did
not promptly correct such information and
data.
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Indeed, the Information to which Dr.
Baxter pled guilty provided that he, ‘‘as
a responsible [RBP] executive failed to
prevent and promptly correct the
distribution of the false and misleading
unintended pediatric exposure data and
marketing claims to MassHealth’’ and
that, accordingly, he caused the
introduction and delivery for
introduction of a misbranded drug into
interstate commerce. He cannot now
hide behind his arguments that he
lacked specific knowledge that the
labeling for the Suboxone Film was false
and misleading in an attempt to
overcome the debarment resulting from
the facts to which he admitted as part
of his plea agreement. As the Supreme
Court has reasoned, in keeping with the
FD&C Act’s purpose of protecting the
public from adulterated and misbranded
products, Congress chose to place the
burden of protecting the public on those
who play a role in manufacturing and
distributing those products rather than
on consumers, who cannot protect
themselves (United States v.
Dotterweich, 320 U.S. 277, 280–81
(1943)). The duty imposed on RCOs
‘‘requires the highest standard of
foresight and vigilance’’:
The requirements of foresight and vigilance
imposed on responsible corporate agents are
beyond question demanding, and perhaps
onerous, but they are no more stringent than
the public has a right to expect of those who
voluntarily assume positions of authority in
business enterprises whose services and
products affect the health and well-being of
the public that supports them (Park, 421 U.S.
at 672–73).
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The type of conduct to which Dr.
Baxter pled guilty failed to meet the
duty imposed on RCOs and undermined
the process for the regulation of drugs
in the sense contemplated by both
section 306(b)(2)(B)(i)(I) and the FD&C
Act as a whole.
In light of the foregoing, the Chief
Scientist has found that Dr. Baxter has
failed to raise a genuine and substantial
issue of fact with respect to: (1) whether
the conduct serving as the basis of his
Federal misdemeanor conviction related
to the regulation of drugs and is the type
of conduct that undermines the process
for the regulation of drugs and thus (2)
whether he is subject to debarment
under the terms of section
306(b)(2)(B)(i)(I) of the FD&C Act.
B. Appropriateness of a 5-Year
Debarment Period
In support of his hearing request, Dr.
Baxter further argues in his
Memorandum that he is entitled to a
hearing on ORA’s findings with respect
to the considerations in section
306(c)(3) of the FD&C Act. Dr. Baxter
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contends that ORA’s assessment of the
nature and seriousness of his offense
and the nature and extent of voluntary
steps to mitigate the impact on the
public were based on errors of fact,
logic, and law. Dr. Baxter also argues
that ORA’s proposal gave insufficient
weight to the third factor, his lack of
prior convictions involving matters
within the jurisdiction of FDA.
Additionally, Dr. Baxter challenges the
appropriateness of the proposed 5-year
debarment period.
Dr. Baxter first challenges ORA’s
assessment of the nature and
seriousness of his offense under section
306(c)(3)(A) of the FD&C Act. Yet, as
ORA found and has been discussed at
length above, Dr. Baxter took
responsibility for RBP’s introducing,
and delivering for introduction, a
misbranded drug into interstate
commerce. Dr. Baxter admitted as part
of his guilty plea that he was in a
position both to prevent the violations
resulting from his subordinate’s
conduct—i.e., the inclusion of false and
misleading information in the labeling
for Suboxone Film—or to correct them
promptly. But he did not. Building on
the reasoning above with respect to
whether the type of conduct serving as
the basis of Dr. Baxter’s misdemeanor
conviction undermined the process for
the regulation of drugs, the Chief
Scientist finds that Dr. Baxter’s role and
responsibility in the introduction of a
drug whose labeling and false and
misleading under section 502(a) of the
FD&C Act—especially when the labeling
at issue went directly to a State
Medicaid agency and when viewed
within the range of potential
misdemeanor convictions that might
subject an individual to permissive
debarment under section
306(b)(2)(B)(i)(I) of the FD&C Act—is
sufficiently serious to warrant treatment
as an unfavorable factor. In short, Dr.
Baxter has failed to raise a genuine and
substantial issue of fact with respect to
ORA’s findings regarding the nature and
seriousness of his offense under section
306(c)(3)(A) of the FD&C Act.
Dr. Baxter next argues that, in
evaluating ‘‘the nature and extent of
voluntary steps to mitigate the impact of
any offense involved’’ under section
306(c)(3)(C) of the FD&C Act, ORA did
not fully consider that there was no
negative impact on the public to
mitigate and that he nonetheless did
play a role in sending a correction letter
to MassHealth. Specifically, Dr. Baxter
maintains that he could not have taken
any action prior to the Federal
government’s investigation into the
matter because he was not aware of the
wrongful conduct. Finally, Dr. Baxter
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Fmt 4703
Sfmt 4703
also contends that ORA ‘‘ignored that
Dr. Baxter accepted responsibility for
his violation and agreed to cooperate
with the Government, as evidenced by
the plea agreement.’’
The facts to which Dr. Baxter pled
guilty belie his arguments now that any
role he played in correcting his
violations should be construed as a
voluntary step taken in mitigation in the
sense contemplated by section
306(c)(3)(C) of the FD&C Act. As part of
his guilty plea, he admitted that he was
an RCO ‘‘with authority to either
prevent in the first instance or to
promptly correct the provision of false
and misleading information to
MassHealth and that he took neither
action.’’ He cannot now claim that his
corrective action was sufficiently
prompt to be meaningful, and he does
not dispute that he directed the
correction ‘‘only after an investigation
was opened into this matter.’’ Dr. Baxter
states that ORA’s proposal does not
‘‘suggest there was any other action that
Dr. Baxter could have or should have
done to ‘mitigate the impact to the
public.’ ’’ He does not, however, present
any reason to believe that he took
additional steps to mitigate the effect of
his offense on the public. Additionally,
Dr. Baxter’s guilty plea does not qualify
as a voluntary step to mitigate the
impact of his offense on the public
under section 306(c)(3)(C) of the FD&C
Act. Accordingly, the Chief Scientist
finds that Dr. Baxter has failed to raise
a genuine and substantial issue of fact
with respect to ORA’s findings
regarding the voluntary steps taken by
him to mitigate the effect of his offense
on the public under section 306(c)(3)(C)
of the FD&C Act.
Based on the undisputed record
before me, primarily encompassing the
facts to which Dr. Baxter pled guilty, the
Chief Scientist finds that a 5-year
debarment is appropriate. Although Dr.
Baxter has no previous criminal
convictions related to matters within the
jurisdiction of FDA, this sole favorable
factor does not counterbalance the
nature and seriousness of his offense
and lack of voluntary steps promptly
taken to mitigate the effect of that
offense on the public. As has been
discussed at length, Dr. Baxter admitted
as part of his guilty plea that, as an RCO,
he possessed the authority, opportunity,
and responsibility to prevent or
promptly correct conduct that caused
false and misleading information to go
to a State Medicaid agency and thereby
caused the introduction of a misbranded
drug into interstate commerce. His
failure to prevent or promptly correct
conduct breached the fundamental
responsibility as an RCO when he
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ddrumheller on DSK120RN23PROD with NOTICES
voluntarily assumed a ‘‘position of
authority in [a] business enterprise
whose services and products affect the
health and well-being of the public’’
(Park, 421 U.S. at 573). In short, the
Chief Scientist agrees with ORA’s
conclusion in its proposal that ‘‘the facts
supporting the unfavorable factors
outweigh those supporting the favorable
factor, and therefore warrant the
imposition of a 5-year period of
debarment.’’
C. Remaining Legal Arguments
Finally, Dr. Baxter argues that
debarring him for 5 years would be
arbitrary and capricious and an abuse of
discretion. Dr. Baxter contends that
debarment is a remedial measure and
that his conduct is ‘‘untethered’’ to that
remedial purpose because his conduct
did not undermine confidence in the
drug approval process and thus ‘‘makes
the deterrence value of any debarment
practically nonexistent—and potentially
harmful.’’ Additionally, he argues that
his one conviction does not warrant
debarment. Dr. Baxter also argues that
debarment would be arbitrary and
capricious because FDA has not
previously debarred an individual in a
‘‘pure’’ RCO case. Finally, Dr. Baxter
contends that debarring him for the
maximum period would be arbitrary
and capricious because his conduct
differs in meaningful ways from that of
others who received 5-year debarments.
As is extensively discussed above,
however, Dr. Baxter did not plead guilty
based purely on strict liability. He
admitted as part of his guilty plea that
he was an RCO ‘‘with authority to either
prevent in the first instance or to
promptly correct the provision of false
and misleading information to
MassHealth and that he took neither
action.’’ (see Park, 421 U.S. at 673–74).
As discussed above, Dr. Baxter’s role at
RBP and his conviction as an RCO does
not lessen the seriousness of the
conviction or underlying conduct but
instead elevates it to a higher level of
concern given his role within the
company.
As Dr. Baxter notes, FDA’s debarment
authority is a remedial measure, and not
a punitive one, and a tool to protect the
public health (see generally DiCola v.
Food and Drug Admin., 77 F.3d 504
(D.C. Cir. 1996); Bhutani v. U.S. Food
and Drug Admin., 161 F. App’x 589, 593
(7th Cir. 2006)). As explained
extensively above, Dr. Baxter’s conduct
significantly undermined the process for
the regulation of drugs. Therefore, his
conduct is not ‘‘untethered’’ to the
remedial purpose of debarment; rather,
his conduct fits squarely into the
category of conduct that warrants
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20:06 Feb 24, 2023
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debarment under section
306(b)(2)(B)(i)(I) of the FD&C Act. While
Dr. Baxter contends that his conduct
does not require any additional
remedial measures, his arguments to
that effect ignore that the conduct
underlying his conviction calls into
question whether, when in a position to
prevent or promptly correct violations
of the FD&C Act, he would do so and
thus uphold the protections to public
health afforded by that statute.
Based on Dr. Baxter’s arguments and
the case law he cites, he appears to be
relying on the judicial standard for
review of Agency decision-making in
the APA at 5 U.S.C. 706(2), which
directs courts to ‘‘hold unlawful and set
aside agency action[s]’’ that are
‘‘arbitrary, capricious, an abuse of
discretion, or otherwise not in
accordance with law.’’ As the Supreme
Court has held, the question under that
standard is whether the Agency has
provided a reasonable explanation for
the substance its decision:
The APA’s arbitrary-and-capricious
standard requires that agency action be
reasonable and reasonably explained.
Judicial review under that standard is
deferential, and a court may not substitute its
own policy judgment for that of the agency.
A court simply ensures that the agency has
acted within a zone of reasonableness and, in
particular, has reasonably considered the
relevant issues and reasonably explained the
decision (FCC v. Prometheus Radio Project,
141 S. Ct. 1150, 1158, 209 L. Ed. 2d 287
(2021)).
In this matter, as reflected in the
lengthy discussion above, the Agency
has reasonably considered the relevant
issues and fully explained its decision
to debar Dr. Baxter.
Although Dr. Baxter points to other
individuals who pled guilty to
misdemeanors based on liability as
RCOs and who have not been debarred,
he provides no details with respect to
those individuals’ convictions. Even
assuming, however, that those
individuals were similarly situated to
him, his bare assertion that an agency
cannot choose to begin pursuing
debarment of individuals for certain
discrete categories of Federal
misdemeanor convictions because it has
not done so in the past is unfounded.
Dr. Baxter further argues, however,
that the Agency has debarred other
individuals for less than 5 years when
it was undisputed that those individuals
did not act with knowledge or intent in
violating the FD&C Act. For example,
Dr. Baxter specifically points to a doctor
who was a principal in a medical
practice who unknowingly used an
unapproved product on patients while
representing that it was an FDA-
PO 00000
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Fmt 4703
Sfmt 4703
12373
approved product (see generally
Douglas M. Hargrave Denial of Hearing;
Final Debarment Order, 80 FR 11995
(March 5, 2015)). As Dr. Baxter notes,
FDA debarred Dr. Hargrave for 2 years
instead of 5 years. However, unlike Dr.
Hargrave Dr. Baxter explicitly admitted
during his criminal proceedings that he
was in a position of authority that
should have enabled him to prevent or
promptly correct the violative conduct.
As discussed, in terms of section
306(b)(2)(B)(i)(I) and 306(c)(3) of the
FD&C Act are clear, and the Agency has
exercised its discretion here in a manner
consistent with the permissive
debarment of many other individuals
convicted of Federal misdemeanors
related to the regulation of drugs.
Accordingly, Dr. Baxter’s argument that
debarring him is arbitrary, capricious,
and contrary to law lacks merit.
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
her by the Commissioner of Food and
Drugs, finds that: (1) Dr. Baxter has been
convicted of a misdemeanor under
Federal law for conduct relating to the
development or approval, including the
process for development or approval, of
a drug product or otherwise relating to
the regulation of a drug product under
the FD&C Act and (2) the type of
conduct which served as the basis for
the conviction undermines the process
for the regulation of drugs. FDA has
considered the applicable factors listed
in section 306(c)(3) of the FD&C Act and
determined that a debarment of 5 years
is appropriate.
As a result of the foregoing findings,
Dr. Baxter is debarred for 5 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 February
27, 2023 (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.
Baxter, in any capacity during his
period of debarment, will be subject to
civil money penalties (section 307(a)(6)
of the FD&C Act (21 U.S.C. 335b(a)(6))).
If Dr. Baxter, 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
(section 307(a)(7) of the FD&C Act). In
addition, FDA will not accept or review
any abbreviated new drug applications
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Federal Register / Vol. 88, No. 38 / Monday, February 27, 2023 / Notices
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’’).
submitted by or with the assistance of
Dr. Baxter during his period of
debarment (section 306(c)(1)(B) of the
FD&C Act).
Dated: February 21, 2023.
Namandje´ N. Bumpus,
Chief Scientist.
[FR Doc. 2023–03946 Filed 2–24–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–0073]
Neovascular Age-Related Macular
Degeneration: Developing Drugs for
Treatment; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Neovascular Age-Related Macular
Degeneration: Developing Drugs for
Treatment.’’ This guidance is intended
to provide recommendations to
sponsors developing drugs intended to
treat neovascular age-related macular
degeneration focusing on eligibility
criteria, trial design considerations, and
efficacy endpoints to enhance clinical
trial data quality and to foster greater
efficiency in development programs.
DATES: Submit either electronic or
written comments on the draft guidance
by May 30, 2023 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES
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
VerDate Sep<11>2014
20:06 Feb 24, 2023
Jkt 259001
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–
2022–D–0073 for ‘‘Neovascular Age
Related Macular Degeneration:
Developing Drugs for Treatment.’’
Received comments 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
made publicly available, submit your
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.’’ The
Agency 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://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
PO 00000
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Sfmt 4703
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://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or the Office of Communication,
Outreach, and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Wiley A. Chambers, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Avenue, Bldg. 22, Rm. 6108,
Silver Spring, MD 20993, 301–796–
0690; or Diane Maloney, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Neovascular Age-Related Macular
Degeneration: Developing Drugs for
Treatment.’’ This draft guidance
document, once finalized, will foster
greater efficiency in development
programs for drugs intended to treat
neovascular age-related macular
degeneration.
This draft guidance is being issued
consistent with FDA’s good guidance
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Agencies
[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Notices]
[Pages 12369-12374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03946]
[[Page 12369]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0028]
Timothy Baxter; Denial of Hearing; Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is denying a
request for a hearing submitted by Dr. Timothy Baxter (Dr. Baxter) and
is issuing an order under the Federal Food, Drug, and Cosmetic Act
(FD&C Act) debarring Dr. Baxter for 5 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. Baxter 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. Baxter's debarment, FDA has considered the applicable factors
listed in the FD&C Act. Dr. Baxter 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 applicable February 27, 2023.
ADDRESSES: Any application for termination of debarment by Dr. Baxter
under section 306(d) of the FD&C Act (21 U.S.C. 335a(d)) (application)
may be submitted as follows:
Electronic Submissions
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because
your application will be made public, you are solely responsible for
ensuring that your application 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 application,
that information will be posted on https://www.regulations.gov.
If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the application 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 a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: Your application must include the Docket No. FDA-
2021-N-0028. An application will be placed in the docket and, unless
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 an application with
confidential information that you do not wish to be made publicly
available, submit your application 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.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of your application. The second copy,
which will have the claimed confidential information redacted/blacked
out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your application and you must identify this
information as ``confidential.'' Any information marked 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-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket, go to https://www.regulations.gov
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852 between 9 a.m. and 4 p.m., Monday through Friday, 240-402-
7500. Publicly available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Rachael Vieder Linowes, Office of
Scientific Integrity, Food and Drug Administration,
[email protected], 240-402-5931.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(2)(B)(i)(I) of the FD&C Act permits FDA to debar an
individual if it finds that: (1) the individual has been convicted of a
misdemeanor under Federal law ``for conduct relating to the development
or approval, including the process for development or approval, of any
drug product or otherwise relating to the regulation of drug products''
under the FD&C Act and (2) the type of conduct that served as the basis
for the conviction undermines the process for the regulation of drugs.
On August 31, 2020, in the U.S. District Court for the Western
District of Virginia, Dr. Baxter pled guilty to a misdemeanor violation
of the FD&C Act. Specifically, he pled guilty to causing the
introduction or delivery for introduction of a misbranded drug into
interstate commerce in violation of sections 301(a), 303(a)(1), and
502(a) of the FD&C Act (21 U.S.C. 331(a), 333(a)(1), and 352(a)). In
the plea agreement pursuant to which Dr. Baxter pled guilty, he agreed
that ``all the facts set forth in the Information [filed by the Federal
government on the same day] are true and correct and provide the Court
with a sufficient factual basis to support [his] plea.'' The
Information provided that, at the time of the conduct underlying his
conviction, Dr. Baxter was the Global Medical Director of Reckitt
Benckiser Pharmaceuticals Inc. (RBP).'' \1\ During that time, according
to the Information, RBP's Medical Affairs Manager, who reported
directly to Dr. Baxter, provided false or misleading analysis and
charts to the Massachusetts Medicaid program (MassHealth), as a means
of persuading MassHealth to
[[Page 12370]]
reimburse patients for a drug named Suboxone Film, which RBP marketed.
---------------------------------------------------------------------------
\1\ As noted in the Information, ``on or about December 23,
2014, RBP was renamed Indivior, Inc, and became a subsidiary of
Indivior PLC. After on or about December 23, 2014, Dr. Baxter was
the Chief Medical Officer of Indivior PLC.''
---------------------------------------------------------------------------
As framed by the Information, the false and misleading data and
analysis provided to MassHealth--relating to the unintended pediatric
exposure rates for Suboxone Film relative to similar tablet products--
constituted ``labeling'' for the drug under section 201(m) of the FD&C
Act (21 U.S.C. 321(m)) and thus misbranded the drug under section
502(a) of the FD&C Act). As discussed further below, in pleading guilty
pursuant to the Information, Dr. Baxter conceded that he was a
responsible corporate officer (RCO) at RBP that ``failed to prevent and
promptly correct the distribution of false and misleading unintended
pediatric exposure data and marketing claims to MassHealth'' and
``caused the introduction and delivery for introduction into interstate
commerce of . . . a drug [(Suboxone Film)] that was misbranded in that
the drug's labeling was false and misleading'' (see United States v.
Park, 421 U.S. 658, 673-74 (1975)).
By letter dated February 25, 2021, FDA's Office of Regulatory
Affairs (ORA) notified Dr. Baxter of its proposal to debar him for 5
years from providing services in any capacity to a person having an
approved or pending drug product application and provided him with an
opportunity to request a hearing on the proposal. ORA found that Dr.
Baxter is subject to debarment under section 306(b)(2)(B)(i)(I) of the
FD&C Act on the basis of his misdemeanor conviction under Federal law
for conduct both relating to the regulation of a drug product under the
FD&C Act and undermining the Agency's process for regulating drugs. The
proposal also outlined findings concerning the factors ORA considered
to be applicable in determining the appropriateness and period of
debarment, as provided in section 306(c)(3) of the FD&C Act. ORA found
that a 5-year period of debarment is appropriate. Specifically, ORA
found that the nature and seriousness of the offense and the nature and
extent of voluntary steps to mitigate the effect on the public are
unfavorable factors for Dr. Baxter. ORA stated that it viewed the
absence of prior convictions involving matters within FDA's
jurisdiction as a favorable factor. ORA concluded that ``the facts
supporting the unfavorable factors outweigh those supporting the
favorable factor and therefore warrant the imposition of a 5-year
period of debarment.''
By letter dated March 26, 2021, through counsel, Dr. Baxter
requested a hearing on ORA's proposal to debar him. On May 4, 2021, he
submitted a ``Memorandum of Facts and Arguments in Support of Hearing
Request'' (Memorandum). In this Memorandum, Dr. Baxter makes legal,
factual, and policy-based arguments regarding the proffered basis for
his debarment in ORA's proposal.
Under the authority delegated to her by the Commissioner of Food
and Drugs, the Chief Scientist has considered Dr. Baxter's request for
a hearing. Hearings are granted only if there is a genuine and
substantial issue of fact. As discussed in more detail below, hearings
will not be granted on issues of policy or law, on mere allegations, on
denials or general descriptions of positions and contentions, on data
and information insufficient to justify the factual determination urged
if accurate and presented at a hearing, or on factual issues that are
not determinative with respect to the action requested (see Sec.
12.24(b) (21 CFR 12.24(b))). The Chief Scientist has considered Dr.
Baxter's arguments and concluded that they are unpersuasive and fail to
raise a genuine and substantial issue of fact requiring a hearing.
II. Arguments
In his Memorandum, Dr. Baxter makes a series of legal and policy
arguments challenging whether he is subject to debarment and, if so,
whether debarment for 5 years is appropriate. Many of Dr. Baxter's
arguments are intertwined with his efforts to raise a genuine and
substantial issue of fact with respect to the findings in ORA's
proposal to debar him. Dr. Baxter's legal and factual arguments largely
turn on the extent to which the specific conduct underlying his
conviction subjects him to debarment under section 306(b)(2)(B)(i) of
the FD&C Act and the extent to which there are genuine and substantial
issues of fact with respect to ORA's findings under section
306(b)(2)(B)(i) and the applicable considerations under section
306(c)(3). In challenging the facts underlying ORA's findings and the
proposed period of debarment, Dr. Baxter contends that some of the
findings in ORA's proposal go beyond the facts to which he admitted
during the criminal proceedings and are demonstrably false.
Specifically, he disputes ORA's proposed findings: (1) that he ``helped
oversee [RBP's] efforts to secure formulary coverage for Suboxone Film
from [MassHealth]'' and a strategy to that end; (2) that his
misdemeanor offense involved the provision of false and misleading
information to MassHealth that included ``overstated safety claims'';
(3) that the conduct underlying his conviction ``put children at
risk.''
In challenging those proposed findings, Dr. Baxter argues
extensively that he is entitled to a hearing because not only are there
genuine and substantial issues of fact with respect to them but they
are conclusory and do not appear to rest on substantial evidence. He
effectively contends, therefore, that he is entitled to a hearing on
those findings for further development and an opportunity to challenge
them. However, nothing in the relevant FDA regulations, section 306(i)
of the FD&C Act, or the Administrative Procedure Act (APA) (5 U.S.C.
551-559) requires more than an opportunity to raise genuine and
substantial issues of fact with respect to the findings in ORA's
proposal. As Dr. Baxter notes, section 306(i) of the FD&C Act requires
FDA to provide an ``opportunity for an agency hearing on disputed
issues of material fact'' before debarring any person. As noted by ORA
in its proposal, FDA implements adjudications required under section 5
U.S.C. 554(a), including debarment matters, as formal evidentiary
hearings under part 12 (21 CFR part 12).
Under Sec. 12.24(b), consistent with the APA and case law, there
are criteria for granting a hearing. Pursuant to that regulation, the
Agency will grant a request for hearing only if the material submitted
in support of the hearing request shows, in relevant part: (1)
``[t]here is a genuine and substantial factual issue for resolution at
a hearing,'' (2) ``[t]he factual issue can be resolved by available and
specifically identified reliable evidence,'' (3) ``[t]he data and
information submitted, if established at a hearing, would be adequate
to justify resolution of the factual issue in the way sought by the
person,'' and (4) ``[r]esolution of the factual issue in the way sought
by the person is adequate to justify the action requested.'' The
regulation further clarifies that ``[a] hearing will not be granted on
issues of policy or law'' and that ``a hearing will not be granted on
factual issues that are not determinative with respect to the action
requested.''
The factual challenges in Dr. Baxter's Memorandum, such as whether
his conduct put children at risk, do not justify granting his hearing
request. Dr. Baxter appears to acknowledge, as he must, that the facts
to which he pled guilty--i.e., the findings of the court that entered a
criminal judgment against him--are not in dispute. Dr. Baxter's
arguments highlighting those findings by ORA that go beyond the facts
to which he admitted as part of his guilty plea do not create a genuine
and
[[Page 12371]]
substantial issue of fact, nor are those findings determinative with
respect to whether Dr. Baxter is subject to debarment and whether a
debarment period of 5 years is appropriate. For reasons discussed in
detail below, it is not necessary to go beyond the facts to which Dr.
Baxter pled guilty and the other undisputed facts in ORA's proposal to
conclude that Dr. Baxter is subject to debarment under section
306(b)(2)(B)(i) of the FD&C Act and that debarment for 5 years is
appropriate under section 306(c)(3).
For the sake of simplicity and efficiency, what follows is an
assessment of Dr. Baxter's legal, factual, and policy-based arguments
by reference only to the facts to which he pled guilty or the other
undisputed findings in ORA's proposal.
A. Dr. Baxter Is Subject to Debarment
Dr. Baxter first argues that he is not subject to debarment under
section 306(b)(2)(B)(i) of the FD&C Act. Dr. Baxter maintains that a
misdemeanor conviction for causing the introduction of a misbranded
drug into interstate commerce under the Responsible Corporate Officer
(RCO) doctrine is ``not sufficient to impose debarment'' and that his
criminal conduct lacks a sufficient nexus to ``the regulation of drug
products'' under the FD&C Act. Dr. Baxter contends that his conduct
does not undermine the process for the regulation of drugs and that,
because the drug product at issue had already received FDA approval,
the misleading communication at issue did not relate to the approval or
the approval process. In support of these arguments, he points to the
legislative history of section 306 of the FD&C Act:
As the House Report to H.R. 2454 explains, this section ``gives
FDA the authority to debar a person . . . for conduct relating to
the development or approval of generic drugs.'' In addition
``[c]onviction of certain other crimes, such as bribery, fraud, and
obstruction of justice, could also be the basis for debarment''
because the seriousness of those crimes undermines the
trustworthiness of the individual, such a conviction ``provide[s]
evidentiary support for a finding that the individual should not be
allowed to submit or assist in the submission of a generic drug
application even though the crime did not directly involve the
approval process'' [emphasis removed]. Thus, there is no indication
that Congress intended to make any conviction under Title 21 grounds
for permissive debarment, regardless of whether or not the conduct
had anything to do with the drug approval process or fraud or
similarly serious offenses.
Dr. Baxter contends that ``the legislative history makes clear that
conduct that `undermines the process for the regulation of drugs' is
conduct that either undermines the approval process itself or
constitutes such egregious fraud that it supports the conclusion that
the individual can never be trusted to participate in the
pharmaceutical industry'' (emphases removed). Finally, Dr. Baxter
argues that ORA's finding that his conduct was of a type that
undermines the process for the regulation of drugs is unsupported
because, while it was ``technical misbranding,'' there was never any
harm or risk to the public.
Section 306(b)(2)(B)(i) of the FD&C Act specifically provides for
debarring individuals convicted of Federal misdemeanors related to the
regulation of drug products. If the language of the statute is clear,
there is no need to look outside the statute to its legislative history
in order to ascertain the statute's meaning (Chamber of Commerce of
United States v. Whiting, 563 U.S. 582, 599 (2011)). Furthermore, as
the Supreme Court has repeatedly held, the language in the FD&C Act
should be construed in a manner that is consistent with its overall
public health purpose. When we are dealing with the public health, the
language of the FD&C Act should not be read too restrictively, but
rather as ``consistent with the Act's overriding purpose to protect the
public health'' (United States v. Article of Drug Bacto-Unidisk, 394
U.S. 784, 798 (1969)).
Dr. Baxter's general argument that the conduct underlying his
conviction lacks a sufficient nexus to the regulation of drugs to
subject him to debarment under section 306(b)(2)(B)(i)(I) of the FD&C
Act lacks merit. Simply put, he pled guilty to causing the introduction
of a misbranded drug into interstate commerce in violation of the FD&C
Act (specifically, sections 301(a), 303(a)(1), and 502(a) of the FD&C
Act). In section 306(b)(2)(B)(i)(I), ``a misdemeanor under Federal law
or a felony under State law for conduct . . . otherwise relating to the
regulation of drug products'' subjects an individual to permissive
debarment. There are no genuine and substantial issues of fact
regarding whether Dr. Baxter pled guilty to--and therefore committed--a
misdemeanor under Federal law. When that Federal misdemeanor is for
conduct that directly violated the FD&C Act with respect to drug
labeling, there is no question that such violation relates to the
regulation of drugs under that statutory authority.
Dr. Baxter makes many similar arguments with respect to whether the
conduct to which he pled guilty as part of his misdemeanor plea is
``the type of conduct [that] . . . undermines the process for the
regulation of drugs'' under the FD&C Act in the sense contemplated by
section 306(b)(2)(B)(i)(I) of the FD&C Act. In doing so, he attempts to
distinguish between conduct relating to the development and approval
process for drug products and conduct relating to other aspects of drug
regulation under the FD&C Act. Although he supports that distinction by
pointing to the legislative history of section 306 and offering policy
arguments, neither section 306(b)(2)(B)(i)(I) nor the FD&C Act as a
whole bear out that distinction. The plain language of section
306(b)(2)(B)(i)(I) does not draw the distinction urged by Dr. Baxter
and indeed expands the scope of the statutory provision beyond conduct
relating to the development and approval process by including the
language ``otherwise relating to the regulation of drug products.''
With respect to the purpose of FD&C Act as a whole, the Supreme Court
has found that its aims go well beyond the development and approval
process for drug products: ``Its purpose [is] to safeguard the consumer
by applying the Act to articles from the moment of their introduction
into interstate commerce all the way to the moment of their delivery to
the ultimate consumer'' (United States v. Sullivan, 332 U.S. 689, 696
(1948)).
The Chief Scientist also rejects Dr. Baxter's further arguments
that he is not subject to debarment under section 306(b)(2)(B)(i)(I) of
the FD&C Act because he pled guilty to a Federal misdemeanor offense
without admitting any intent to violate the law or knowledge of
wrongdoing and because the underlying offense did not involve ``fraud,
bribery, [or] similar crimes.'' Given that section 306(b)(2)(B)(i) of
the FD&C Act explicitly permits debarring individuals convicted of
Federal misdemeanors related to the regulation of drug products and
that a misdemeanor violation of the FD&C Act itself is a strict
liability offense under section 303(a)(1) of the FD&C Act, it stands to
reason that criminal intent is not required to subject an individual to
debarment under section 306(b)(2)(B)(i)(I). As ORA correctly
determined, however, his conduct went beyond a mere technical violation
of the FD&C Act:
[Dr. Baxter's] actions undermined the process for the regulation
of drugs because [he] failed to prevent [RBC] from sending false and
misleading data and information to MassHealth related to the rate of
unintended pediatric exposure to Suboxone Film and did not promptly
correct such information and data.
[[Page 12372]]
Indeed, the Information to which Dr. Baxter pled guilty provided
that he, ``as a responsible [RBP] executive failed to prevent and
promptly correct the distribution of the false and misleading
unintended pediatric exposure data and marketing claims to MassHealth''
and that, accordingly, he caused the introduction and delivery for
introduction of a misbranded drug into interstate commerce. He cannot
now hide behind his arguments that he lacked specific knowledge that
the labeling for the Suboxone Film was false and misleading in an
attempt to overcome the debarment resulting from the facts to which he
admitted as part of his plea agreement. As the Supreme Court has
reasoned, in keeping with the FD&C Act's purpose of protecting the
public from adulterated and misbranded products, Congress chose to
place the burden of protecting the public on those who play a role in
manufacturing and distributing those products rather than on consumers,
who cannot protect themselves (United States v. Dotterweich, 320 U.S.
277, 280-81 (1943)). The duty imposed on RCOs ``requires the highest
standard of foresight and vigilance'':
The requirements of foresight and vigilance imposed on
responsible corporate agents are beyond question demanding, and
perhaps onerous, but they are no more stringent than the public has
a right to expect of those who voluntarily assume positions of
authority in business enterprises whose services and products affect
the health and well-being of the public that supports them (Park,
421 U.S. at 672-73).
The type of conduct to which Dr. Baxter pled guilty failed to meet
the duty imposed on RCOs and undermined the process for the regulation
of drugs in the sense contemplated by both section 306(b)(2)(B)(i)(I)
and the FD&C Act as a whole.
In light of the foregoing, the Chief Scientist has found that Dr.
Baxter has failed to raise a genuine and substantial issue of fact with
respect to: (1) whether the conduct serving as the basis of his Federal
misdemeanor conviction related to the regulation of drugs and is the
type of conduct that undermines the process for the regulation of drugs
and thus (2) whether he is subject to debarment under the terms of
section 306(b)(2)(B)(i)(I) of the FD&C Act.
B. Appropriateness of a 5-Year Debarment Period
In support of his hearing request, Dr. Baxter further argues in his
Memorandum that he is entitled to a hearing on ORA's findings with
respect to the considerations in section 306(c)(3) of the FD&C Act. Dr.
Baxter contends that ORA's assessment of the nature and seriousness of
his offense and the nature and extent of voluntary steps to mitigate
the impact on the public were based on errors of fact, logic, and law.
Dr. Baxter also argues that ORA's proposal gave insufficient weight to
the third factor, his lack of prior convictions involving matters
within the jurisdiction of FDA. Additionally, Dr. Baxter challenges the
appropriateness of the proposed 5-year debarment period.
Dr. Baxter first challenges ORA's assessment of the nature and
seriousness of his offense under section 306(c)(3)(A) of the FD&C Act.
Yet, as ORA found and has been discussed at length above, Dr. Baxter
took responsibility for RBP's introducing, and delivering for
introduction, a misbranded drug into interstate commerce. Dr. Baxter
admitted as part of his guilty plea that he was in a position both to
prevent the violations resulting from his subordinate's conduct--i.e.,
the inclusion of false and misleading information in the labeling for
Suboxone Film--or to correct them promptly. But he did not. Building on
the reasoning above with respect to whether the type of conduct serving
as the basis of Dr. Baxter's misdemeanor conviction undermined the
process for the regulation of drugs, the Chief Scientist finds that Dr.
Baxter's role and responsibility in the introduction of a drug whose
labeling and false and misleading under section 502(a) of the FD&C
Act--especially when the labeling at issue went directly to a State
Medicaid agency and when viewed within the range of potential
misdemeanor convictions that might subject an individual to permissive
debarment under section 306(b)(2)(B)(i)(I) of the FD&C Act--is
sufficiently serious to warrant treatment as an unfavorable factor. In
short, Dr. Baxter has failed to raise a genuine and substantial issue
of fact with respect to ORA's findings regarding the nature and
seriousness of his offense under section 306(c)(3)(A) of the FD&C Act.
Dr. Baxter next argues that, in evaluating ``the nature and extent
of voluntary steps to mitigate the impact of any offense involved''
under section 306(c)(3)(C) of the FD&C Act, ORA did not fully consider
that there was no negative impact on the public to mitigate and that he
nonetheless did play a role in sending a correction letter to
MassHealth. Specifically, Dr. Baxter maintains that he could not have
taken any action prior to the Federal government's investigation into
the matter because he was not aware of the wrongful conduct. Finally,
Dr. Baxter also contends that ORA ``ignored that Dr. Baxter accepted
responsibility for his violation and agreed to cooperate with the
Government, as evidenced by the plea agreement.''
The facts to which Dr. Baxter pled guilty belie his arguments now
that any role he played in correcting his violations should be
construed as a voluntary step taken in mitigation in the sense
contemplated by section 306(c)(3)(C) of the FD&C Act. As part of his
guilty plea, he admitted that he was an RCO ``with authority to either
prevent in the first instance or to promptly correct the provision of
false and misleading information to MassHealth and that he took neither
action.'' He cannot now claim that his corrective action was
sufficiently prompt to be meaningful, and he does not dispute that he
directed the correction ``only after an investigation was opened into
this matter.'' Dr. Baxter states that ORA's proposal does not ``suggest
there was any other action that Dr. Baxter could have or should have
done to `mitigate the impact to the public.' '' He does not, however,
present any reason to believe that he took additional steps to mitigate
the effect of his offense on the public. Additionally, Dr. Baxter's
guilty plea does not qualify as a voluntary step to mitigate the impact
of his offense on the public under section 306(c)(3)(C) of the FD&C
Act. Accordingly, the Chief Scientist finds that Dr. Baxter has failed
to raise a genuine and substantial issue of fact with respect to ORA's
findings regarding the voluntary steps taken by him to mitigate the
effect of his offense on the public under section 306(c)(3)(C) of the
FD&C Act.
Based on the undisputed record before me, primarily encompassing
the facts to which Dr. Baxter pled guilty, the Chief Scientist finds
that a 5-year debarment is appropriate. Although Dr. Baxter has no
previous criminal convictions related to matters within the
jurisdiction of FDA, this sole favorable factor does not counterbalance
the nature and seriousness of his offense and lack of voluntary steps
promptly taken to mitigate the effect of that offense on the public. As
has been discussed at length, Dr. Baxter admitted as part of his guilty
plea that, as an RCO, he possessed the authority, opportunity, and
responsibility to prevent or promptly correct conduct that caused false
and misleading information to go to a State Medicaid agency and thereby
caused the introduction of a misbranded drug into interstate commerce.
His failure to prevent or promptly correct conduct breached the
fundamental responsibility as an RCO when he
[[Page 12373]]
voluntarily assumed a ``position of authority in [a] business
enterprise whose services and products affect the health and well-being
of the public'' (Park, 421 U.S. at 573). In short, the Chief Scientist
agrees with ORA's conclusion in its proposal that ``the facts
supporting the unfavorable factors outweigh those supporting the
favorable factor, and therefore warrant the imposition of a 5-year
period of debarment.''
C. Remaining Legal Arguments
Finally, Dr. Baxter argues that debarring him for 5 years would be
arbitrary and capricious and an abuse of discretion. Dr. Baxter
contends that debarment is a remedial measure and that his conduct is
``untethered'' to that remedial purpose because his conduct did not
undermine confidence in the drug approval process and thus ``makes the
deterrence value of any debarment practically nonexistent--and
potentially harmful.'' Additionally, he argues that his one conviction
does not warrant debarment. Dr. Baxter also argues that debarment would
be arbitrary and capricious because FDA has not previously debarred an
individual in a ``pure'' RCO case. Finally, Dr. Baxter contends that
debarring him for the maximum period would be arbitrary and capricious
because his conduct differs in meaningful ways from that of others who
received 5-year debarments.
As is extensively discussed above, however, Dr. Baxter did not
plead guilty based purely on strict liability. He admitted as part of
his guilty plea that he was an RCO ``with authority to either prevent
in the first instance or to promptly correct the provision of false and
misleading information to MassHealth and that he took neither action.''
(see Park, 421 U.S. at 673-74). As discussed above, Dr. Baxter's role
at RBP and his conviction as an RCO does not lessen the seriousness of
the conviction or underlying conduct but instead elevates it to a
higher level of concern given his role within the company.
As Dr. Baxter notes, FDA's debarment authority is a remedial
measure, and not a punitive one, and a tool to protect the public
health (see generally DiCola v. Food and Drug Admin., 77 F.3d 504 (D.C.
Cir. 1996); Bhutani v. U.S. Food and Drug Admin., 161 F. App'x 589, 593
(7th Cir. 2006)). As explained extensively above, Dr. Baxter's conduct
significantly undermined the process for the regulation of drugs.
Therefore, his conduct is not ``untethered'' to the remedial purpose of
debarment; rather, his conduct fits squarely into the category of
conduct that warrants debarment under section 306(b)(2)(B)(i)(I) of the
FD&C Act. While Dr. Baxter contends that his conduct does not require
any additional remedial measures, his arguments to that effect ignore
that the conduct underlying his conviction calls into question whether,
when in a position to prevent or promptly correct violations of the
FD&C Act, he would do so and thus uphold the protections to public
health afforded by that statute.
Based on Dr. Baxter's arguments and the case law he cites, he
appears to be relying on the judicial standard for review of Agency
decision-making in the APA at 5 U.S.C. 706(2), which directs courts to
``hold unlawful and set aside agency action[s]'' that are ``arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with
law.'' As the Supreme Court has held, the question under that standard
is whether the Agency has provided a reasonable explanation for the
substance its decision:
The APA's arbitrary-and-capricious standard requires that agency
action be reasonable and reasonably explained. Judicial review under
that standard is deferential, and a court may not substitute its own
policy judgment for that of the agency. A court simply ensures that
the agency has acted within a zone of reasonableness and, in
particular, has reasonably considered the relevant issues and
reasonably explained the decision (FCC v. Prometheus Radio Project,
141 S. Ct. 1150, 1158, 209 L. Ed. 2d 287 (2021)).
In this matter, as reflected in the lengthy discussion above, the
Agency has reasonably considered the relevant issues and fully
explained its decision to debar Dr. Baxter.
Although Dr. Baxter points to other individuals who pled guilty to
misdemeanors based on liability as RCOs and who have not been debarred,
he provides no details with respect to those individuals' convictions.
Even assuming, however, that those individuals were similarly situated
to him, his bare assertion that an agency cannot choose to begin
pursuing debarment of individuals for certain discrete categories of
Federal misdemeanor convictions because it has not done so in the past
is unfounded.
Dr. Baxter further argues, however, that the Agency has debarred
other individuals for less than 5 years when it was undisputed that
those individuals did not act with knowledge or intent in violating the
FD&C Act. For example, Dr. Baxter specifically points to a doctor who
was a principal in a medical practice who unknowingly used an
unapproved product on patients while representing that it was an FDA-
approved product (see generally Douglas M. Hargrave Denial of Hearing;
Final Debarment Order, 80 FR 11995 (March 5, 2015)). As Dr. Baxter
notes, FDA debarred Dr. Hargrave for 2 years instead of 5 years.
However, unlike Dr. Hargrave Dr. Baxter explicitly admitted during his
criminal proceedings that he was in a position of authority that should
have enabled him to prevent or promptly correct the violative conduct.
As discussed, in terms of section 306(b)(2)(B)(i)(I) and 306(c)(3)
of the FD&C Act are clear, and the Agency has exercised its discretion
here in a manner consistent with the permissive debarment of many other
individuals convicted of Federal misdemeanors related to the regulation
of drugs. Accordingly, Dr. Baxter's argument that debarring him is
arbitrary, capricious, and contrary to law lacks merit.
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 her by the Commissioner
of Food and Drugs, finds that: (1) Dr. Baxter has been convicted of a
misdemeanor under Federal law for conduct relating to the development
or approval, including the process for development or approval, of a
drug product or otherwise relating to the regulation of a drug product
under the FD&C Act and (2) the type of conduct which served as the
basis for the conviction undermines the process for the regulation of
drugs. FDA has considered the applicable factors listed in section
306(c)(3) of the FD&C Act and determined that a debarment of 5 years is
appropriate.
As a result of the foregoing findings, Dr. Baxter is debarred for 5
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 February
27, 2023 (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. Baxter, in any
capacity during his period of debarment, will be subject to civil money
penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))).
If Dr. Baxter, 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 (section
307(a)(7) of the FD&C Act). In addition, FDA will not accept or review
any abbreviated new drug applications
[[Page 12374]]
submitted by or with the assistance of Dr. Baxter during his period of
debarment (section 306(c)(1)(B) of the FD&C Act).
Dated: February 21, 2023.
Namandj[eacute] N. Bumpus,
Chief Scientist.
[FR Doc. 2023-03946 Filed 2-24-23; 8:45 am]
BILLING CODE 4164-01-P