[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)]
[Notices]
[Pages 23469-23470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10685]


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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.

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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


