
[Federal Register: November 13, 2009 (Volume 74, Number 218)]
[Notices]               
[Page 58639]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no09-66]                         


[[Page 58639]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0292]

 
Michelle Lynn Torgerson; Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) (the agency) is issuing 
an order under the Federal Food, Drug, and Cosmetic Act (the act) 
permanently debarring Michelle Lynn Torgerson, 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 Ms. Torgerson 
was convicted of a felony under Federal law for conduct relating to the 
regulation of a drug product under the act. Ms. Torgerson was given 
notice of the proposed permanent debarment and an opportunity to 
request a hearing within the timeframe prescribed by regulation. As of 
October 26, 2009, Ms. Torgerson has failed to respond. Ms. Torgerson's 
failure to respond constitutes a waiver of her right to a hearing 
concerning this action.

DATES: This order is effective November 13, 2009.

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 Federal Food, Drug, and Cosmetic Act 
(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 January 4, 2006, the U.S. District Court for the District of 
Minnesota entered judgment against Michelle L. Torgerson for one count 
of misbranding a drug, a federal felony offense under sections 301(k), 
303(a)(2), and 352(b)(1) (21 U.S.C. 331(k), 333(a)(2), and 353(b)(1)), 
after accepting her guilty plea on May 19, 2005. This offense was 
committed when Michelle L. Torgerson was employed as a nurse by Maxim 
Health Systems in the State of Minnesota. During that time, Ms. 
Torgerson conducted unauthorized flu vaccination clinics on the campus 
of Augsburg College, without the approval of her employer, Maxim Health 
Systems. Ms. Torgerson also falsely represented that the American Heart 
Association was sponsoring or otherwise authorizing the clinics. 
Michelle L. Torgerson acknowledged that, in conducting the unauthorized 
clinics, she acted with the intent to defraud and mislead the public 
and that she caused a quantity of a prescription drug, namely, the flu 
virus vaccine Fluzone[reg], to be misbranded within the meaning of 21 
U.S.C. 353(b)(1), while the flu virus vaccine was being held for sale 
after being shipped in interstate commerce. Specifically, Ms. Torgerson 
acknowledged that she dispensed the flu virus vaccine without a written 
prescription of a practitioner licensed by law to administer the flu 
virus vaccine. Ms. Torgerson knew that, as a Licensed Practical Nurse, 
she was not authorized to dispense the flu virus vaccine without a 
physician's orders. She also acknowledged that she diluted some of the 
vaccine with saline knowing that this would reduce the flu vaccine's 
quality and strength.
    As a result of this conviction, FDA sent Ms. Torgerson by certified 
mail on August 7, 2009, a notice proposing to permanently debar her 
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 Michelle L. 
Torgerson was convicted of a felony under Federal law for conduct 
relating to the regulation of a drug product under the act. The 
proposal also offered Ms. Torgerson an opportunity to request a 
hearing, 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. Ms. Torgerson failed to respond 
within the timeframe prescribed by regulation and has, therefore, 
waived her opportunity for a hearing and any contentions concerning her 
debarment (21 CFR 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, and under 
authority delegated to the Acting Director (Staff Manual Guide 
1410.35), finds that Michelle L. Torgerson 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, Ms. Torgerson 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), 306(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 Michelle L. Torgerson, in 
any capacity, during Ms. Torgerson's permanent debarment, will be 
subject to civil money penalties (section 307(a)(6) of the act (21 
U.S.C. 335b(a)(6)). If Ms. Torgerson, 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 applications submitted by or 
with the assistance of Ms. Torgerson during her period of debarment 
(section 306(c)(1)(B) of the act).
    Any application by Ms. Torgerson for special termination of 
debarment under section 306(d)(4) of the act should be identified with 
Docket No. FDA-2009-N-0292 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: October 28, 2009.
Brenda Holman,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. E9-27223 Filed 11-12-09; 8:45 am]

BILLING CODE 4160-01-S
