[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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