[Federal Register Volume 76, Number 64 (Monday, April 4, 2011)]
[Notices]
[Pages 18556-18557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7782]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0474]
Maja S. Ruetschi: 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) debarring
Maja S. Ruetschi, MD for 5 years from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on findings that Dr. Ruetschi was
convicted of a misdemeanor under Federal law for conduct relating to
the regulation of a drug product under the FD&C Act and that the type
of conduct underlying the conviction undermines the process for the
regulation of drugs. Dr. Ruetschi was given notice of the proposed
debarment and an opportunity to request a hearing within the timeframe
prescribed by regulation. Dr. Ruetschi failed to respond. Dr.
Ruetschi's failure to respond constitutes a waiver of her right to a
hearing concerning this action.
DATES: This order is effective April 4, 2011.
ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-
[[Page 18557]]
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, 5600 Fishers Lane, Rockville, MD 20857,
301-796-4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds
that the individual has been convicted of a misdemeanor under Federal
law for conduct relating to the regulation of drug products under the
FD&C Act, and if FDA finds that the type of conduct that served as the
basis for the conviction undermines the process for the regulation of
drugs.
On June 18, 2008, Dr. Ruetschi pleaded guilty to a misdemeanor
offense of receipt and delivery of a misbranded drug in interstate
commerce in violation of 21 U.S.C. 331(c), 333(a)(1), and 352(f). On
July 2, 2008, the U.S. District Court for the Central District of
California entered judgment against Dr. Ruetschi for receipt in
interstate commerce of misbranded drug and delivery thereof.
FDA's finding that debarment is appropriate is based on the
misdemeanor conviction referenced herein. The factual basis for the
conviction is as follows: Dr. Ruetschi was a licensed medical doctor in
the State of California and maintained an office in Palm Desert, CA.
Beginning on or about January 20, 2004, and continuing until on or
about October 20, 2004, Dr. Ruetschi began ordering from Toxin
International, Inc., (TRI) an unapproved drug product represented to be
a Botulinum Toxin Type A product (TRI-toxin). Specifically, Dr.
Ruetschi placed 11 orders for a total of 11 vials of TRI-toxin, which
was shipped in interstate commerce from Tucson, AZ to her office in
Palm Desert, CA. Dr. Ruetschi subsequently administered the TRI-toxin
to her patients for the treatment of facial wrinkles. The TRI-toxin
bore warnings that it was not for human use and did not bear any
directions for human use, and was misbranded under 21 U.S.C. 352(f) in
that it lacked adequate directions for use.
As a result of her convictions, on January 5, 2011, FDA sent Dr.
Ruetschi a notice by certified mail proposing to debar her for 5 years
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(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)), that Dr. Ruetschi was convicted of a misdemeanor
under Federal law for conduct relating to the regulation of drug
products under the FD&C Act, and the conduct that served as a basis for
the conviction undermines the process for the regulation of drugs. The
proposal also offered Dr. Ruetschi 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. Dr. Ruetschi failed to respond
within the timeframe prescribed by regulation and has, therefore,
waived her opportunity for a hearing and waived any contentions
concerning her debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(b)(2)(B)(i)(I) of the FD&C Act
under authority delegated to him (Staff Manual Guide 1410.35), finds
that Maja S. Ruetschi has been convicted of a misdemeanor under Federal
law for conduct relating to the regulation of a drug product under the
FD&C Act, and that the type of conduct that served as a basis for the
conviction undermines the process for the regulation of drugs.
As a result of the foregoing finding, Dr. Ruetschi is debarred for
5 years 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 sections 306(c)(1)(B), (c)(2)(A)(iii), and 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.
Ruetschi, in any capacity during Dr. Ruetschi's debarment, will be
subject to civil money penalties (section 307(a)(6) of the FD&C Act (21
U.S.C. 335b(a)(6))). If Dr. Ruetschi provides services in any capacity
to a person with an approved or pending drug product application during
her period of debarment she 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 submitted by or with
the assistance of Dr. Ruetschi during her period of debarment (section
306(c)(1)(B) of the FD&C Act).
Any application by Dr. Ruetschi for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2010-N-0474 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: March 23, 2011.
Howard Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-7782 Filed 4-1-11; 8:45 am]
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