[Federal Register Volume 75, Number 21 (Tuesday, February 2, 2010)]
[Notices]
[Page 5332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-2135]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0420]


Brian Ullom: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (the act) permanently 
debarring Brian Ullom 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 Mr. Ullom was convicted of a felony 
under Federal law for conduct relating to the regulation of a drug 
product under the act. Mr. Ullom was given notice of the proposed 
permanent debarment and an opportunity to request a hearing within the 
timeframe prescribed by regulation. As of December 2, 2009, Mr. Ullom 
failed to respond. Mr. Ullom's failure to respond constitutes a waiver 
of his right to a hearing concerning this action.

DATES: This order is effective February 2, 2010.

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, Office of Regulatory 
Affairs (HFC-230), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 240-632-6844.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the 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 otherwise relating 
to the regulation of any drug product under the act.
    On August 17, 2009, the U.S. District Court for the Western 
District of Kentucky entered judgment against Brian Ullom for one count 
of participation in a scheme to defraud health care benefit programs by 
billing patients and patients' health care benefit programs, including 
Medicare and Medicaid, for prescription drug samples and for 
prescriptions that were never filled, in violation of 18 U.S.C. 1347; 
and one count of knowingly selling, purchasing and trading prescription 
drug samples with the intent to defraud, in violation of sections 
301(t) and 503(c)(1) of the act (21 U.S.C. 331(t) and 353(c)(1)).
    FDA's finding that debarment is appropriate is based on the felony 
conviction related to the sale of drug samples. The factual basis for 
this conviction is as follows: Beginning in or about 2002 and 
continuing until on or about October 12, 2006, Mr. Ullom, with the 
intent to defraud, knowingly sold, purchased, and traded prescription 
drug samples. During that time period, Mr. Ullom obtained prescription 
drug samples by purchasing the drug samples from others, including a 
local physician and a pharmaceutical sales representative. After 
obtaining the samples, he removed the drugs from their original sample 
packaging and sold them to the public through his pharmacy. At the time 
of sale, he knew the drugs were samples, and he resold them with the 
intent to defraud and mislead the purchaser by selling the sample drugs 
as drugs properly obtained and dispensed.
    As a result of this conviction, FDA sent Mr. Ullom by certified 
mail on October 27, 2009, a notice 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 act that Brian Ullom was 
convicted of a felony under Federal law for conduct relating to the 
regulation of a drug product under the act. In accordance with section 
306(i) of the act and part 12 (21 CFR part 12), the proposal also 
offered Mr. Ullom 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. Accordingly, Mr. Ullom had to request a hearing 
by December 2, 2009. As of December 2, 2009, Mr. Ullom had not 
responded to the notice. Mr. Ullom thus failed to respond within the 
timeframe prescribed by regulation and as a result has waived both his 
opportunity for a hearing and waived any contentions concerning his 
debarment (21 U.S.C. 335(a)(i); part 12)).

II. Findings and Order

    Therefore, the Acting Director, Office of Enforcement, Office of 
Regulatory Affairs, under section 306(a)(2)(B) of the act, under 
authority delegated to the Acting Director (Staff Manual Guide 
1410.35), finds that Brian Ullom has been convicted of a felony under 
Federal law for conduct relating to the regulation of a drug product 
under the act.
    As a result of the foregoing finding, Mr. Ullom 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 (see DATES) 
(see sections 306(c)(1)(B), (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 employs or retains as a consultant or 
contractor, or otherwise uses the services of Brian Ullom, in any 
capacity, during Mr. Ullom's debarment, will be subject to civil money 
penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6))). If Mr. 
Ullom, during his period of debarment, provides services in any 
capacity to a person with an approved or pending drug product 
application, he 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 applications submitted by or with the assistance 
of Mr. Ullom during his period of debarment (section 306(c)(1)(B) of 
the act).
    Any application by Mr. Ullom for special termination of debarment 
under section 306(d)(4) of the act should be identified with Docket No. 
FDA-2009-N-0420 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: January 8, 2010.
Brenda Holman,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2010-2135 Filed 2-1-10; 8:45 am]
BILLING CODE 4160-01-S