[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]
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