[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]]

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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

     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.
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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

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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.

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


