FR DATE:09/02/2008

[Federal Register: September 2, 2008 (Volume 73, Number 170)]

[Notices]               
[Page 51305-51306]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02se08-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-N-0166] (formerly Docket No. 2006N-0238)

 
Maria Anne Kirkman Campbell; Denial of Hearing; Debarment Order

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (the act) permanently 
debarring Dr. Maria Anne Kirkman Campbell (Dr. Campbell) from providing 
services in any capacity to a person that has an approved or pending 
drug product application. We base this order on a finding that Dr. 
Campbell was convicted of a felony under Federal law for conduct 
relating to the development or approval, including the process for 
development or approval, of a drug product, and conduct otherwise 
relating to the regulation of a drug product under the act. Dr. 
Campbell failed to request a hearing and, therefore, has waived her 
opportunity for a hearing concerning this action. Even assuming that 
any statement in Dr. Campbell's correspondence with FDA were to be 
construed as requesting a hearing, Dr. Campbell has failed to file with 
the agency information and analyses sufficient to create a basis for a 
hearing concerning this action. Therefore, we are, in the alternative, 
issuing an order denying any such assumed request for a hearing because 
we find that there is no genuine and substantial issue of fact to grant 
a hearing on the debarment, if a hearing were requested.

DATES:  This order is effective September 2, 2008.

ADDRESSES:  Submit applications for termination of debarment to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Brian Pendleton, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6304, Silver Spring, MD, 20993-0002, 301-
796-3504.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(A) of the act (21 U.S.C. 335a(a)(2)(A)) requires 
debarment of an individual if FDA finds that the individual has been 
convicted of a felony under Federal law for conduct relating to the 
development or approval, including the process for development or 
approval, of any drug product. Section 306(a)(2)(B) of the act requires 
debarment of an individual if FDA finds that the individual has been 
convicted of a felony under Federal law for conduct otherwise relating 
to the regulation of any drug product under the act.
    On March 25, 2004, the U.S. District Court for the Northern 
District of Alabama accepted Dr. Campbell's plea of guilty and 
convicted her of one count of mail fraud, a felony under 18 U.S.C. 1341 
and 2. Specifically, Dr. Campbell admitted to submitting a fraudulent 
case report form (reflecting enrollment of a nonexistent person) while 
serving as a clinical investigator in a clinical study designed to test 
the safety and effectiveness of an antibacterial drug product, Ketek 
(telithromycin), for the treatment of respiratory tract infections. The 
clinical study was to be submitted to FDA in support of approval of 
Ketek.
    Accordingly, in a letter dated February 28, 2007, and hand 
delivered on March 5, 2007, FDA served Dr. Campbell a notice proposing 
to permanently debar her from providing services in any capacity to a 
person having an approved or pending drug product application. The 
proposal was based on a finding, under section 306(a)(2)(A) and 
(a)(2)(B) of the act, that Dr. Campbell was convicted of a felony under 
Federal law for conduct relating to the development or approval, 
including the process for development or approval, of a drug product, 
and conduct otherwise relating to the regulation of a drug product. The 
letter offered Dr. Campbell an opportunity to request a hearing on the 
proposal, providing her 30 days from the date of receipt of the letter 
in which to file the request, and advised her that failure to request a 
hearing constituted a waiver of the opportunity for a hearing and of 
any contentions concerning this action.
    The letter also informed Dr. Campbell that her request for a 
hearing could not rest upon mere allegations or denials, but must 
present specific facts showing that there is a genuine and substantial 
issue of fact requiring a hearing. In addition, the letter informed Dr. 
Campbell that the only material issue of fact was whether she was 
convicted as alleged in the letter, and that the facts underlying her 
conviction are not at issue in this proceeding. The letter also 
informed Dr. Campbell that if it conclusively appeared from the face of 
the information and factual analyses in her request for a hearing that 
there was no genuine and substantial issue of fact that precluded the 
order of debarment, we would deny her request for a hearing and enter a 
final order of debarment. Finally, the letter informed Dr. Campbell 
that if she were to file a request for a hearing, she was required to 
file, on or before 60 days from the date of receipt of the letter, the 
information on which she relied to justify a hearing.
    Dr. Campbell has responded to the proposal to debar her but has not 
requested a hearing.\1\ Her failure to request a hearing constitutes a 
waiver of her opportunity for a hearing and a waiver of any contentions 
concerning her debarment.
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    \1\After we served Dr. Campbell on March 5, 2007, with notice of 
the agency's proposal to debar her, Dr. Campbell sent a series of 
letters to the agency--dated March 9, 2007, April 6, 2007, May 23, 
2007, July 17, 2007, August 21, 2007, and January 13, 2008,--and 
participated in a teleconference with FDA on April 9, 2007. Although 
some of Dr. Campbell's correspondence refers to another proceeding 
the agency initiated against Dr. Campbell (investigator 
disqualification under 21 CFR 312.70), instead of, or in addition 
to, the proposal to debar her, for the purposes of this order, we 
have taken into account all of Dr. Campbell's correspondence with 
the agency after March 5, 2007, as well as the transcript from the 
April 9, 2007, teleconference.
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    Even assuming that any statement in Dr. Campbell's correspondence 
with FDA were to be construed as requesting a hearing, Dr. Campbell has 
not submitted information that would justify granting a hearing. 
Therefore, we are, in the alternative, hereby denying any such assumed 
request for a hearing because Dr. Campbell has failed to show that 
there is a genuine and substantial issue of fact requiring a hearing. 
Dr. Campbell has not offered any information or factual analyses to 
refute that she was convicted of mail fraud for conduct relating to the 
development or approval of a drug product, or otherwise relating to the 
regulation of a drug product under the act.

II. Findings and Order

    Therefore, the Associate Commissioner for Regulatory Affairs, under 
section 306(a)(2)(A) and (a)(2)(B) of the act and under authority 
delegated to her, finds that Dr. Maria Anne Kirkman Campbell has been 
convicted of a felony under Federal law for conduct relating to the 
development or approval, including the process for

[[Page 51306]]

development or approval, of a drug product, and conduct otherwise 
relating to the regulation of a drug product under the act.
    As a result of the foregoing finding, Dr. Maria Anne Kirkman 
Campbell is permanently debarred from providing services in any 
capacity to a person with an approved or pending drug product 
application under sections 505, 512, or 802 of the 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 as stated in the DATES section of this 
document (see section 306(c)(1)(B) and (c)(2)(A)(ii) and 201(dd) of the 
act (21 U.S.C. 321(dd))). Any person with an approved or pending drug 
product application who knowingly uses the services of Dr. Campbell in 
any capacity, during her period of debarment, will be subject to civil 
money penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6))). 
If Dr. Campbell, during her period of debarment, provides services in 
any capacity to a person with an approved or pending drug product 
application, she will be subject to civil money penalties (section 
307(a)(7) of the act). In addition, FDA will not accept or review any 
abbreviated new drug application submitted by or with the assistance of 
Dr. Campbell during her period of debarment (section 306(c)(1)(B) of 
the act).
    Any application by Dr. Campbell for special termination of 
debarment under section 306(d)(4) of the act should be identified with 
Docket No. FDA-2006-N-0166 and sent to the Division of Dockets 
Management (see ADDRESSES). All such submissions are to be filed in 
four copies. The public availability of information in these 
submissions is governed by 21 CFR 10.20(j). Publicly available 
submissions may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

    Dated: August 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20295 Filed 8-29-08; 8:45 am]

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