[Federal Register Volume 76, Number 64 (Monday, April 4, 2011)]
[Notices]
[Pages 18557-18558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7783]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0476]


Marilyn A. Mehlmauer: 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 
Marilyn Mehlmauer, MD for 4 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. Mehlmauer 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. Mehlmauer was given notice of the proposed 
debarment and an opportunity to request a hearing within the timeframe 
prescribed by regulation. Dr. Mehlmauer failed to respond. Dr. 
Mehlmauer'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-305), Food and Drug Administration,

[[Page 18558]]

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 November 13, 2007, Dr. Mehlmauer pleaded guilty to a misdemeanor 
offense of Receipt in Interstate Commerce of Misbranded Drug and 
Delivery thereof in violation of 21 U.S.C. 331(c), 333(a)(1), and 
352(f). On November 13, 2007 the U.S. District Court, for the Central 
District of California entered judgment against Dr. Mehlmauer for 
misdemeanor misbranding.
    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. Mehlmauer was a physician with an office 
located in Pasadena, CA. In August 2003, Dr. Mehlmauer began ordering 
an unapproved drug product represented to be a Botulinum Toxin Type A 
drug product (TRI-toxin) manufactured by Toxin Research International, 
Inc. (TRI), located in Tucson, AZ. From on or about August 27, 2003, 
and continuing to on or about November 22, 2004, Dr. Mehlmauer placed 
12 orders for a total of 26 vials of TRI-toxin, which she had shipped 
to her office. The TRI-toxin did not come with labeling or directions 
on how to dilute the product for injection, and therefore was 
misbranded under 21 U.S.C. 352(f) in that it lacked adequate directions 
for use. The TRI-toxin label stated ``for research purposes only'' and 
``not for human use.'' Dr. Mehlmauer admitted to injecting the 
unapproved TRI-toxin into patients and on some occasions to 
representing to patients that the TRI-toxin was BOTOX[supreg]/
BOTOX[supreg] Cosmetic, at that time the only approved Botulinum Toxin 
Type A drug. Dr. Mehlmauer delivered and proffered for delivery the 
unapproved, misbranded TRI-toxin when she ordered, received, and 
administered it to other persons, all in violation of 21 U.S.C. 331(c), 
333(a)(1), and 352(f).
    As a result of her convictions, on January 19, 2011, FDA sent Dr. 
Mehlmauer a notice by certified mail proposing to debar her for 4 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, that Dr. 
Mehlmauer 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. 
Mehlmauer 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. Mehlmauer 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 Marilyn Mehlmauer 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. Mehlmauer is debarred for 
4 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 section 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. 
Mehlmauer, in any capacity during Dr. Mehlmauer'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. Mehlmauer 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. Mehlmauer during her period of debarment (section 
306(c)(1)(B) of the FD&C Act).
    Any application by Dr. Mehlmauer for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2010-N-0476 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. 2011-7783 Filed 4-1-11; 8:45 am]
BILLING CODE 4160-01-P