83 FR 23469 - Mary C. Holloway; Order Revoking a Proposed Order of Debarment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 98 (May 21, 2018)

Page Range		23469-23470
FR Document		2018-10685

The Food and Drug Administration (FDA) is revoking a proposed order, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), to debar Mary C. Holloway (Holloway) for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. Holloway, through counsel, filed a request for a hearing, as well as information and analysis in support of that request, in response to the proposed debarment order. FDA has determined that pursuing debarment of Holloway is no longer appropriate.

Federal Register, Volume 83 Issue 98 (Monday, May 21, 2018)

[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)]
[Notices]
[Pages 23469-23470]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-10685]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0361]


Mary C. Holloway; Order Revoking a Proposed Order of Debarment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is revoking a proposed 
order, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), to 
debar Mary C. Holloway (Holloway) for 5 years from providing services 
in any capacity to a person that has an approved or pending drug 
product application. Holloway, through counsel, filed a request for a 
hearing, as well as information and analysis in support of that 
request, in response to the proposed debarment order. FDA has 
determined that pursuing debarment of Holloway is no longer 
appropriate.

DATES: This order is applicable May 21, 2018.

FOR FURTHER INFORMATION CONTACT: Nathan Sabel, Office of Scientific 
Integrity, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 301-796-8588.

SUPPLEMENTARY INFORMATION:

I. Background

    On April 8, 2009, Holloway, formerly a regional sales manager at 
Pharmacia & Upjohn Company, Inc. (Pharmacia), pled guilty to a Federal 
misdemeanor offense under sections 301(a), 303(a)(1), and 502(f) of the 
FD&C Act (21 U.S.C. 331(a), 333(a)(1), and 352(f)). In June 2009, the 
U. S. District Court for the District of Massachusetts entered the 
conviction and sentenced Holloway to probation. The basis for the 
conviction was Holloway's involvement in Pharmacia's introduction into 
interstate commerce of its drug BEXTRA, a pain reliever and anti-
inflammatory, for the unapproved use of treating pre- and postoperative 
surgical pain. Before it was removed from the market several years 
later, BEXTRA was only approved for treatment of arthritis and primary 
dysmenorrhea. In September 2009, Pharmacia pled guilty to a felony 
violation of the FD&C Act for the promotion of BEXTRA and other drugs 
for unapproved uses.
    By letter dated January 20, 2010, FDA's Office of Regulatory 
Affairs (ORA) notified Holloway of a proposal to debar her for 5 years 
from providing services in any capacity to a person having an approved 
or pending drug product application. The proposal stated that Holloway 
is subject to permissive debarment based on a finding, under section 
306(b)(2)(B)(i) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)), that she 
was convicted of a misdemeanor under Federal law for conduct relating 
to the regulation of a drug product and that the type of conduct 
serving as the basis for the conviction undermines the process for the 
regulation of drugs. The proposal further concluded that Holloway 
should be debarred for the maximum period of 5 years under section 
306(c)(2)(A)(iii) of the FD&C Act based on four applicable 
considerations in section 306(c)(3).
    In a letter dated February 18, 2010, through counsel, Holloway 
requested a hearing on the proposal. On March 24, 2010, Holloway 
submitted materials and arguments in support of her request. In her 
submissions, Holloway acknowledged her conviction of a misdemeanor 
under Federal law. Holloway conceded that she is subject to debarment 
as a result of this conviction, but she argues nonetheless that she is 
entitled to a hearing to determine whether permissive debarment is 
appropriate. Specifically, Holloway argued that, with respect to the 
considerations for determining the appropriateness and period of 
debarment under section 306(c)(3) of the FD&C Act, there are genuine 
and substantial issues of fact for resolution at a hearing.
    By letter dated April 3, 2013, the Office of the Commissioner, in 
order to determine whether granting a hearing would be appropriate, 
requested that ORA submit a response to Holloway's request for a 
hearing. ORA was invited to include any documentary evidence, 
information, or analysis that it deemed appropriate in support of its 
response. Holloway was afforded an opportunity to submit evidence and 
arguments in opposition. ORA submitted its response on August 30, 2013. 
Holloway, through counsel, replied to ORA's response on November 15, 
2013.
    Under Sec.  12.26 (21 CFR 12.26), if FDA determines upon review of 
a request for hearing that the order at issue should be modified or 
revoked, FDA may modify or revoke the order by notice in the Federal 
Register. Based upon a review of the record, the Acting Chief Scientist 
concludes that it is appropriate under Sec.  12.26, in this instance, 
to revoke the proposed order to debar Holloway for 5 years.

II. Arguments

    In the proposal to debar Holloway for 5 years, ORA noted that there 
are four applicable considerations for determining the appropriateness 
and period of Holloway's debarment under section 306(c)(3) of the FD&C 
Act: (1) The nature and seriousness of her offense under section 
306(c)(3)(A); (2) the nature and extent of management participation in 
the offense under section 306(c)(3)(B); (3) the nature and extent of 
voluntary steps taken to mitigate the impact on the public under 
section 306(c)(3)(C); and (4) prior convictions involving matters 
within the jurisdiction of FDA under section 306(c)(3)(F). ORA found 
that the first three of those considerations weigh in favor of 
debarment and noted, as to the fourth consideration, that FDA is 
unaware of any prior convictions. In finding that the each of the first 
three considerations weighs in favor of debarment, ORA appears to have 
characterized Holloway's conduct based on contested allegations from 
Holloway's criminal proceedings.
    Holloway challenged both ORA's conclusions with respect to all 
three considerations in dispute and the factual underpinnings of those 
conclusions. Holloway contended that, under section 306(i) of the FD&C 
Act, FDA may not take any action under sections 306(b) or section 
306(c) with respect to any person ``unless [FDA] has issued an order 
for such action made on the record after opportunity for an agency 
hearing on disputed issues of material fact.'' Section 306(c)(3) 
explicitly requires that FDA consider, ``where applicable,'' certain 
factors ``[i]n determining the appropriateness and the period of 
debarment'' for any permissive debarment.
    In proposing to debar Holloway for 5 years, ORA appears to have 
based its findings with respect to certain considerations in section 
306(c)(3) of the FD&C Act largely on the factual

[[Page 23470]]

allegations in the criminal information to which Holloway pled guilty 
under her plea agreement. As Holloway argues, however, the records of 
her criminal proceedings reflect that she did not admit to any of the 
specific factual allegations in the information during the plea 
colloquy conducted by the court. In fact, her attorney during the 
criminal proceedings explicitly stated, ``[The information] contains 
many allegations that Ms. Holloway disputes.'' After the prosecution 
summarized the evidence that it planned to introduce at trial, which 
closely mirrored the allegations in the information, the court accepted 
Holloway's guilty plea on the basis of the following exchange:

    THE COURT: Okay. I gather that some of the facts are in dispute; 
is that correct?
    THE DEFENDANT: Correct.
    THE COURT: Do you want to make a statement or, counsel, do you 
want to make a statement?
* * * * *
    [DEFENSE COUNSEL]: Ms. Holloway is, she is prepared to admit 
that she promoted BEXTRA for off label usage, and she understands 
that that constitutes the introduction of BEXTRA into interstate 
commerce with inadequate directions for use.
    THE COURT: All right. Ms. Holloway, do you agree, do you accept 
your counsel's representation as to the facts that you accept to be 
true?
    THE DEFENDANT: Yes, ma'am.

    In her request for a hearing and subsequent submissions (March 24, 
2010, and November 15, 2013), Holloway argued that her lack of 
admission to any specific facts during her criminal proceedings calls 
into question ORA's findings with respect to certain considerations 
under section 306(c)(3). In addition, with regard to certain ORA 
allegations in the proposed order to debar Holloway (January 20, 2010), 
and in support of facts weighing against debarment, Holloway has 
presented particularized challenges supported by explanations or 
documentary evidence.
    After a review of the record, the Acting Chief Scientist concludes 
that, given the exceptional circumstances of this matter, it appears 
that it would likely be necessary to grant the pending request for a 
hearing. Such a hearing would require a broad scope to address any 
genuine and substantial issues of fact that are material to weighing 
the applicable considerations under section 306(c)(3) of the FD&C Act. 
As a result of this extraordinary posture, the scope of the disputed 
facts in this matter includes many of the facts that a prior criminal 
proceeding would typically have established, as well as those 
additional facts in dispute that relate to certain of the applicable 
debarment considerations in section 306(c)(3) of the FD&C Act. Because 
few factual findings relating to Holloway's specific conduct and 
actions between December 2001 and April 2005 underlying her 2009 
conviction were generated during the criminal proceedings, a hearing to 
establish ORA's proposed findings would require a substantial devotion 
of the Agency's limited resources to this individual debarment 
proceeding.
    The Acting Chief Scientist has weighed the Agency's limited 
resources against the factors that weigh in favor of proceeding to 
evaluate ORA's proposed debarment order at an evidentiary hearing. 
Chief among these countervailing considerations are the nature and 
seriousness of the offense articulated by ORA and the Agency's interest 
in effectuating the remedial purpose of the statute in furtherance of 
the public health. The Acting Chief Scientist has accorded significant 
weight to those countervailing considerations but, in reaching a 
decision in this matter, has balanced those considerations against the 
extraordinary resources necessary to conduct an evidentiary hearing on 
the factual underpinnings for ORA's proposed findings as to the 
considerations in section 306(c)(3) of the FD&C Act, when there were 
few specific facts established as part of the criminal proceeding.
    After a careful evaluation of the arguments and information 
provided by both ORA and Holloway as they relate to the nature and 
breadth of the factual disputes at issue here, and after a 
consideration of the resources necessary to proceed under this unusual 
set of circumstances, the Acting Chief Scientist has determined that 
the revocation of the proposed order to debar Holloway is appropriate 
in this instance.

III. Order

    Upon review of the request for hearing, evidence, and arguments, 
the Acting Chief Scientist revokes the January 20, 2010, proposed order 
to debar Holloway and provides this notice of revocation in the Federal 
Register as required by Sec.  12.26.

    Dated: May 14, 2018.
Denise Hinton,
Acting Chief Scientist.
[FR Doc. 2018-10685 Filed 5-18-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 98 / Monday, May 21, 2018 / Notices 23469

Budget (OMB) under the Paperwork conviction and sentenced Holloway to Holloway was afforded an opportunity
Reduction Act of 1995 (44 U.S.C. 3501– probation. The basis for the conviction to submit evidence and arguments in
3520). The collections of information in was Holloway’s involvement in opposition. ORA submitted its response
21 CFR part 514 have been approved Pharmacia’s introduction into interstate on August 30, 2013. Holloway, through
under OMB control number 0910–0032. commerce of its drug BEXTRA, a pain counsel, replied to ORA’s response on
reliever and anti-inflammatory, for the November 15, 2013.
IV. Electronic Access unapproved use of treating pre- and Under § 12.26 (21 CFR 12.26), if FDA
Persons with access to the internet postoperative surgical pain. Before it determines upon review of a request for
may obtain the draft guidance at either was removed from the market several hearing that the order at issue should be
https://www.fda.gov/AnimalVeterinary/ years later, BEXTRA was only approved modified or revoked, FDA may modify
GuidanceComplianceEnforcement/ for treatment of arthritis and primary or revoke the order by notice in the
GuidanceforIndustry/default.htm or dysmenorrhea. In September 2009, Federal Register. Based upon a review
https://www.regulations.gov. Pharmacia pled guilty to a felony of the record, the Acting Chief Scientist
Dated: May 15, 2018. violation of the FD&C Act for the concludes that it is appropriate under
promotion of BEXTRA and other drugs § 12.26, in this instance, to revoke the
Leslie Kux,
for unapproved uses. proposed order to debar Holloway for 5
Associate Commissioner for Policy.
By letter dated January 20, 2010, years.
[FR Doc. 2018–10722 Filed 5–18–18; 8:45 am] FDA’s Office of Regulatory Affairs
II. Arguments
BILLING CODE 4164–01–P (ORA) notified Holloway of a proposal
to debar her for 5 years from providing In the proposal to debar Holloway for
services in any capacity to a person 5 years, ORA noted that there are four
DEPARTMENT OF HEALTH AND having an approved or pending drug applicable considerations for
HUMAN SERVICES product application. The proposal determining the appropriateness and
stated that Holloway is subject to period of Holloway’s debarment under
Food and Drug Administration section 306(c)(3) of the FD&C Act: (1)
permissive debarment based on a
[Docket No. FDA–2009–N–0361] finding, under section 306(b)(2)(B)(i) of The nature and seriousness of her
the FD&C Act (21 U.S.C. offense under section 306(c)(3)(A); (2)
Mary C. Holloway; Order Revoking a 335a(b)(2)(B)(i)), that she was convicted the nature and extent of management
Proposed Order of Debarment of a misdemeanor under Federal law for participation in the offense under
conduct relating to the regulation of a section 306(c)(3)(B); (3) the nature and
AGENCY: Food and Drug Administration,
drug product and that the type of extent of voluntary steps taken to
HHS.
conduct serving as the basis for the mitigate the impact on the public under
ACTION: Notice. section 306(c)(3)(C); and (4) prior
conviction undermines the process for
SUMMARY: The Food and Drug the regulation of drugs. The proposal convictions involving matters within
Administration (FDA) is revoking a further concluded that Holloway should the jurisdiction of FDA under section
proposed order, under the Federal Food, be debarred for the maximum period of 306(c)(3)(F). ORA found that the first
Drug, and Cosmetic Act (FD&C Act), to 5 years under section 306(c)(2)(A)(iii) of three of those considerations weigh in
the FD&C Act based on four applicable favor of debarment and noted, as to the
debar Mary C. Holloway (Holloway) for
considerations in section 306(c)(3). fourth consideration, that FDA is
5 years from providing services in any
In a letter dated February 18, 2010, unaware of any prior convictions. In
capacity to a person that has an
through counsel, Holloway requested a finding that the each of the first three
approved or pending drug product
hearing on the proposal. On March 24, considerations weighs in favor of
application. Holloway, through counsel,
2010, Holloway submitted materials and debarment, ORA appears to have
filed a request for a hearing, as well as
arguments in support of her request. In characterized Holloway’s conduct based
information and analysis in support of
her submissions, Holloway on contested allegations from
that request, in response to the proposed
acknowledged her conviction of a Holloway’s criminal proceedings.
debarment order. FDA has determined Holloway challenged both ORA’s
that pursuing debarment of Holloway is misdemeanor under Federal law.
Holloway conceded that she is subject conclusions with respect to all three
no longer appropriate. considerations in dispute and the
to debarment as a result of this
DATES: This order is applicable May 21, conviction, but she argues nonetheless factual underpinnings of those
2018. that she is entitled to a hearing to conclusions. Holloway contended that,
FOR FURTHER INFORMATION CONTACT: determine whether permissive under section 306(i) of the FD&C Act,
Nathan Sabel, Office of Scientific debarment is appropriate. Specifically, FDA may not take any action under
Integrity, Food and Drug Holloway argued that, with respect to sections 306(b) or section 306(c) with
Administration, 10903 New Hampshire the considerations for determining the respect to any person ‘‘unless [FDA] has
Ave., Bldg. 1, Rm. 4206, Silver Spring, appropriateness and period of issued an order for such action made on
MD 20993, 301–796–8588. debarment under section 306(c)(3) of the the record after opportunity for an
SUPPLEMENTARY INFORMATION: FD&C Act, there are genuine and agency hearing on disputed issues of
substantial issues of fact for resolution material fact.’’ Section 306(c)(3)
I. Background at a hearing. explicitly requires that FDA consider,
On April 8, 2009, Holloway, formerly By letter dated April 3, 2013, the ‘‘where applicable,’’ certain factors ‘‘[i]n
a regional sales manager at Pharmacia & Office of the Commissioner, in order to
sradovich on DSK3GMQ082PROD with NOTICES

determining the appropriateness and the
Upjohn Company, Inc. (Pharmacia), determine whether granting a hearing period of debarment’’ for any permissive
pled guilty to a Federal misdemeanor would be appropriate, requested that debarment.
offense under sections 301(a), 303(a)(1), ORA submit a response to Holloway’s In proposing to debar Holloway for 5
and 502(f) of the FD&C Act (21 U.S.C. request for a hearing. ORA was invited years, ORA appears to have based its
331(a), 333(a)(1), and 352(f)). In June to include any documentary evidence, findings with respect to certain
2009, the U. S. District Court for the information, or analysis that it deemed considerations in section 306(c)(3) of
District of Massachusetts entered the appropriate in support of its response. the FD&C Act largely on the factual

VerDate Sep<11>2014 18:20 May 18, 2018 Jkt 244001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM 21MYN1

23470 Federal Register / Vol. 83, No. 98 / Monday, May 21, 2018 / Notices

allegations in the criminal information certain of the applicable debarment DEPARTMENT OF HEALTH AND
to which Holloway pled guilty under considerations in section 306(c)(3) of HUMAN SERVICES
her plea agreement. As Holloway the FD&C Act. Because few factual
argues, however, the records of her findings relating to Holloway’s specific Health Resources and Services
criminal proceedings reflect that she did conduct and actions between December Administration
not admit to any of the specific factual 2001 and April 2005 underlying her
allegations in the information during the Recruitment of Sites for Assignment of
2009 conviction were generated during National Health Service Corps
plea colloquy conducted by the court. In the criminal proceedings, a hearing to
fact, her attorney during the criminal Scholarship Program Participants
establish ORA’s proposed findings
proceedings explicitly stated, ‘‘[The would require a substantial devotion of AGENCY: Health Resources and Services
information] contains many allegations the Agency’s limited resources to this Administration (HRSA), Department of
that Ms. Holloway disputes.’’ After the individual debarment proceeding. Health and Human Services (HHS).
prosecution summarized the evidence ACTION: Notice.
that it planned to introduce at trial, The Acting Chief Scientist has
which closely mirrored the allegations weighed the Agency’s limited resources SUMMARY: This notice announces that
in the information, the court accepted against the factors that weigh in favor of the listing of entities that will receive
Holloway’s guilty plea on the basis of proceeding to evaluate ORA’s proposed priority for assignments of National
the following exchange: debarment order at an evidentiary Health Service Corps (NHSC)
THE COURT: Okay. I gather that some of hearing. Chief among these Scholarship recipients (NHSC scholars)
the facts are in dispute; is that correct? countervailing considerations are the was posted on the Health Workforce
THE DEFENDANT: Correct. nature and seriousness of the offense Connector website (formerly known as
THE COURT: Do you want to make a articulated by ORA and the Agency’s the NHSC Jobs Center) at https://
statement or, counsel, do you want to make interest in effectuating the remedial connector.hrsa.gov/. The Health
a statement? purpose of the statute in furtherance of Workforce Connector includes sites
* * * * * the public health. The Acting Chief approved to receive an assignment of
[DEFENSE COUNSEL]: Ms. Holloway is, Scientist has accorded significant NHSC scholars who are available for
she is prepared to admit that she promoted service during the period of October 1,
BEXTRA for off label usage, and she
weight to those countervailing
considerations but, in reaching a 2018, through September 30, 2019, as
understands that that constitutes the well as the site’s Health Professional
introduction of BEXTRA into interstate decision in this matter, has balanced
Shortage Area (HPSA) scores. Please
commerce with inadequate directions for use. those considerations against the
THE COURT: All right. Ms. Holloway, do note that entities on this list may or may
extraordinary resources necessary to
you agree, do you accept your counsel’s not have current job vacancies.
conduct an evidentiary hearing on the
representation as to the facts that you accept DATES: Entities interested in providing
factual underpinnings for ORA’s
to be true? additional data and information in
THE DEFENDANT: Yes, ma’am. proposed findings as to the
support of their inclusion on the
considerations in section 306(c)(3) of proposed listing, or in support of a
In her request for a hearing and the FD&C Act, when there were few
subsequent submissions (March 24, higher priority determination, must do
specific facts established as part of the so in writing no later than June 20,
2010, and November 15, 2013),
criminal proceeding. 2018.
Holloway argued that her lack of
admission to any specific facts during After a careful evaluation of the ADDRESSES: Entities wishing to submit
her criminal proceedings calls into arguments and information provided by information to support an entity’s
question ORA’s findings with respect to both ORA and Holloway as they relate inclusion on the list or to request a
certain considerations under section to the nature and breadth of the factual higher priority determination should
306(c)(3). In addition, with regard to disputes at issue here, and after a submit it to Beth Dillon, Director,
certain ORA allegations in the proposed consideration of the resources necessary Division of Regional Operations, Bureau
order to debar Holloway (January 20, to proceed under this unusual set of of Health Workforce, 1961 Stout Street,
2010), and in support of facts weighing circumstances, the Acting Chief Denver, CO 80294. HRSA will consider
against debarment, Holloway has Scientist has determined that the this information when preparing the
presented particularized challenges revocation of the proposed order to final list of entities that receive priority
supported by explanations or debar Holloway is appropriate in this for the assignment of NHSC scholars.
documentary evidence. instance. SUPPLEMENTARY INFORMATION: The
After a review of the record, the program is not subject to the provisions
Acting Chief Scientist concludes that, III. Order of Executive Order 12372,
given the exceptional circumstances of Intergovernmental Review of Federal
this matter, it appears that it would Upon review of the request for
hearing, evidence, and arguments, the Programs (as implemented through 45
likely be necessary to grant the pending CFR part 100).
request for a hearing. Such a hearing Acting Chief Scientist revokes the
would require a broad scope to address January 20, 2010, proposed order to Evaluation and Selection Process
any genuine and substantial issues of debar Holloway and provides this notice In approving applications for the
fact that are material to weighing the of revocation in the Federal Register as assignment of NHSC scholars, the HHS
applicable considerations under section required by § 12.26.
sradovich on DSK3GMQ082PROD with NOTICES

Secretary shall give priority to any such
306(c)(3) of the FD&C Act. As a result Dated: May 14, 2018. application that is made for a position
of this extraordinary posture, the scope Denise Hinton, in a HPSA with the greatest shortage.
of the disputed facts in this matter HPSAs of greatest shortage are defined
Acting Chief Scientist.
includes many of the facts that a prior by its HPSA scores.
criminal proceeding would typically [FR Doc. 2018–10685 Filed 5–18–18; 8:45 am] For the program year October 1, 2018,
have established, as well as those BILLING CODE 4164–01–P through September 30, 2019, priority for
additional facts in dispute that relate to assignment of NHSC scholars will be

VerDate Sep<11>2014 18:20 May 18, 2018 Jkt 244001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM 21MYN1

Document Created: 2018-11-02 11:07:24
Document Modified: 2018-11-02 11:07:24

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		This order is applicable May 21, 2018.
Contact		Nathan Sabel, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 301-796-8588.
FR Citation		83 FR 23469

83 FR 23469 - Mary C. Holloway; Order Revoking a Proposed Order of Debarment

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 98 (May 21, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration