[Federal Register Volume 77, Number 164 (Thursday, August 23, 2012)]
[Notices]
[Pages 51030-51031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-20784]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0246]


Kelly Dean Shrum: 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 FD&C Act) 
permanently debarring Kelly Dean Shrum, 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. Shrum was 
convicted of a felony under Federal law for conduct relating to the 
regulation of a drug product under the FD&C Act. Dr. Shrum was given 
notice of the proposed permanent debarment and an opportunity to 
request a hearing within the timeframe prescribed by regulation. Dr. 
Shrum failed to respond. Dr. Shrum's failure to respond constitutes a 
waiver of his right to a hearing concerning this action.

DATES: This order is effective August 23, 2012.

ADDRESSES: Submit applications for special 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: Kenny Shade, Division of Compliance 
Policy (HFC-230), Office of Enforcement, Office of Regulatory Affairs, 
Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 
301-796-4640.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) 
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 regulation of any drug product under the FD&C Act.
    On September 30, 2011, the U.S. District Court for the Eastern 
District of Arkansas entered judgment against Dr. Shrum for 
misbranding, a class A misdemeanor in violation of 21 U.S.C. sections 
331(a), 333(a)(1), 352(c), and 352(f)(1), and health care fraud, a 
class C felony in violation of 18 U.S.C. sections 1347 and 2.
    FDA's finding that debarment is appropriate is based on the felony 
conviction referenced herein for conduct relating to the regulation of 
a drug product. The factual basis for this conviction is as follows: 
Dr. Shrum was a licensed physician practicing in the state of Arkansas. 
Dr. Shrum offered gynecological and obstetric services to women, 
including providing forms of birth control. Dr. Shrum favored the 
intrauterine device (IUD) known as MIRENA, which was made for BHCP, 
Inc., by Bayer Schering Pharma OY (Bayer). The only version of MIRENA 
approved by FDA for marketing in the United States was approved on 
December 6, 2000, in New Drug Application 21-225.
    From in or about June of 2009, in the Eastern District of Arkansas 
and elsewhere, Dr. Shrum purchased a foreign version of MIRENA for use 
in his patients that was not FDA-approved. The labeling of the 
unapproved IUD was not in English, and did not include adequate 
directions for use. Arkansas Center for Women, Ltd. was registered with 
the Arkansas Medicaid Program. Dr. Shrum was listed as the only 
physician affiliated with that clinic, and he signed the Medicaid 
provider contract on behalf of the Arkansas Center for Women. Dr. Shrum 
submitted claims to the Arkansas Medicaid Program under the clinic's 
provider number for the FDA-approved MIRENA IUD, which was specific to 
Bayer's FDA-approved product.
    From on or about January 15, 2008 through on or about June 12, 
2009, Dr. Shrum caused to be submitted claims for reimbursement to the 
Arkansas Medicaid Program, which included false representations. 
Specifically, he billed the Arkansas Medicaid Program as if he were 
administering the FDA-approved version of MIRENA, when he was actually 
administering a non-FDA approved IUD.
    As a result of his convictions, on May 9, 2012, FDA sent Dr. Shrum 
a notice by certified mail proposing to permanently debar him from 
providing services in any capacity to a person that has an approved or 
pending drug product application. The proposal was based on a finding, 
under section 306(a)(2)(B) of the FD&C Act, that Dr. Shrum was 
convicted of a felony under Federal law for conduct relating to the 
regulation of a drug product under the FD&C Act.

[[Page 51031]]

    The proposal also offered Dr. Shrum an opportunity to request a 
hearing, providing him 30 days from the date of receipt of the letter 
in which to file the request, and advised him that failure to request a 
hearing constituted a waiver of the opportunity for a hearing and of 
any contentions concerning this action. The proposal was received on 
May 11, 2012. Dr. Shrum failed to respond and has, therefore, waived 
his opportunity for a hearing and has waived any contentions concerning 
his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement, Office of 
Regulatory Affairs, under section 306(a)(2)(B) of the FD&C Act, under 
authority delegated to him (Staff Manual Guide 1410.35), finds that 
Kelly Dean Shrum has been convicted of a felony under Federal law for 
conduct relating to the regulation of a drug product under the FD&C 
Act.
    As a result of the foregoing finding, Dr. Shrum 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 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 (see 
DATES) (see section 306(c)(1)(B) and (c)(2)(A)(ii) of the FD&C Act and 
section 201(dd) of the FD&C Act (21 U.S.C. 321(dd))). Any person with 
an approved or pending drug product application who knowingly employs 
or retains as a consultant or contractor, or otherwise uses the 
services of Dr. Shrum in any capacity during Dr. Shrum's debarment, 
will be subject to civil money penalties (section 307(a)(6) of the Act 
(21 U.S.C. 335b(a)(6))). If Dr. Shrum provides services in any capacity 
to a person with an approved or pending drug product application during 
his period of debarment 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 from Dr. Shrum during his 
period of debarment (section 306(c)(1)(B) of the FD&C Act.
    Any application by Dr. Shrum for special termination of debarment 
under section 306(d)(4) of the FD&C Act should be identified with 
Docket No. FDA-2012-N-0246 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 8, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2012-20784 Filed 8-22-12; 8:45 am]
BILLING CODE 4160-01-P