Notice2023-03946
Timothy Baxter; Denial of Hearing; Final Debarment Order
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 27, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 38 (Monday, February 27, 2023)</title>
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[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Notices]
[Pages 12369-12374]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03946]
[[Page 12369]]
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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.
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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
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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,
<a href="/cdn-cgi/l/email-protection#075566646f66626b294b6e696870627447616366296f6f7429606871"><span class="__cf_email__" data-cfemail="de8cbfbdb6bfbbb2f092b7b0b1a9bbad9eb8babff0b6b6adf0b9b1a8">[email protected]</span></a>, 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.
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\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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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
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</html>Indexed from Federal Register on February 27, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.