
[Federal Register Volume 76, Number 216 (Tuesday, November 8, 2011)]
[Notices]
[Pages 69272-69273]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28877]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0444]


Gayle Rothenberg: 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) 
permanently debarring Gayle Rothenberg, MD, 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 Dr. Rothenberg was 
convicted of felonies under Federal law for conduct relating to the 
regulation of a drug product under the FD&C Act. Dr. Rothenberg was 
given notice of the proposed permanent debarment and an opportunity to 
request a hearing within the timeframe prescribed by regulation. Dr. 
Rothenberg failed to respond. Dr. Rothenberg's failure to respond 
constitutes a waiver of her right to a hearing concerning this action.

DATES: This order is effective November 8, 2011.

ADDRESSES: Submit applications for special termination of debarment to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration,

[[Page 69273]]

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, (301) 796-4640.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 306(a)(2)(B) of the FD&C 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 relating 
to the regulation of any drug product under the FD&C Act.
    On April 20, 2010, the U.S. District Court for the Southern 
District of Texas entered judgment against Dr. Rothenberg for one 
felony count of, with intent to defraud and mislead, misbranding a drug 
while held for sale after shipment in interstate commerce in violation 
of 21 U.S.C. 331(k), 333(a)(2), 352(i)(3) and 18 U.S.C. 2, and one 
felony count of intentionally and knowingly, in a matter within the 
jurisdiction of FDA, making a false statement to an agent of FDA in 
violation of 18 U.S.C. 1001.
    FDA's finding that debarment is appropriate is based on the felony 
convictions referenced herein for conduct relating to the regulation of 
a drug product. The factual basis for this conviction is as follows: 
Dr. Rothenberg was a physician licensed by the State of Texas as a 
medical doctor with a specialty in the area of anesthesiology. Dr. 
Rothenberg served as the medical director and operated a medical clinic 
in the Southern District of Texas. The medical clinic provided and 
performed services related to the enhancement of the physical 
appearance of clients and included BOTOX injections.
    From February to September 2004, Dr. Rothenberg and her office 
manager caused staff members to order a botulinum toxin type A (TRI-
toxin) product from Toxin Research International, Inc. (TRI) that was 
not approved by FDA. Dr. Rothenberg informed staff members that a new 
BOTOX product would be used to treat patients. When the orders from TRI 
were received, the invoice accompanying the order as well as packaging 
and labeling on each vial indicated that the TRI-toxin was for research 
purposes only and not for human use. Dr. Rothenberg was aware that the 
product was not intended for human use; however, she performed 
injections and used the TRI-toxin on patients at her medical practice 
from February through September 2004. Dr. Rothenberg misrepresented to 
patients that they were receiving injections of authentic BOTOX and 
BOTOX Cosmetic when in fact she knew the patients were receiving 
injections of non-FDA approved TRI-toxin.
    On January 20, 2005, agents of FDA traveled to Dr. Rothenberg's 
clinic and spoke to her about whether any TRI-toxin had been ordered 
and used on patients of the medical clinic. Dr. Rothenberg confirmed 
that the nonapproved product had been ordered but stated that it had 
only been administered to friends and family. On February 28, 2005, 
agents of FDA again traveled to Dr. Rothenberg's clinic and presented 
10 invoices showing that the clinic had ordered the TRI-toxin. This 
time Dr. Rothenberg stated that the product had been used on patients 
without her knowledge and approval. Dr. Rothenberg indicated that 
approximately 210 patients received injections of the TRI-toxin during 
the period of February 4 and September 8, 2004. Agents of FDA reviewed 
billing statements from Dr. Rothenberg's clinic and determined that the 
clinic received approximately $98,000 from patients who received 
injections of the non-FDA approved TRI-toxin.
    Dr. Rothenberg pleaded guilty to, with intent to defraud or 
mislead, misbranding a drug while held for sale after shipment in 
interstate commerce, in violation of Title 21 U.S.C. 331(k), 333(a)(2), 
352(i)(3) and 18 U.S.C. 2, and to making a false statement to an agent 
of FDA in violation of 18 U.S.C. 1001.
    As a result of her convictions, on August 22, 2011, FDA sent Dr. 
Rothenberg a notice by certified mail 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 FD&C Act, that Dr. 
Rothenberg was convicted of felonies under Federal law for conduct 
relating to the regulation of a drug product under the FD&C Act. The 
proposal also offered Dr. Rothenberg 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. The proposal was received on 
August 30, 2011. Dr. Rothenberg failed to respond within the timeframe 
prescribed by regulation and has, therefore, waived her opportunity for 
a hearing and has 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(a)(2)(B) of the FD&C Act, under 
authority delegated to the Director (Staff Manual Guide 1410.35), finds 
that Gayle Rothenberg has been convicted of felonies under Federal law 
for conduct relating to the regulation of a drug product under the FD&C 
Act.
    As a result of the foregoing finding, Dr. Rothenberg 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 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) and (c)(2)(A)(ii) of the FD&C Act and 
section 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. Rothenberg, in any capacity during Dr. Rothenberg'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. Rothenberg 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. Rothenberg 
during her period of debarment (section 306(c)(1)(B) of the FD&C Act).
    Any application by Dr. Rothenberg for special termination of 
debarment under section 306(d)(4) of the FD&C Act should be identified 
with Docket No. FDA-2011-N-0444 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 25, 2011.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-28877 Filed 11-7-11; 8:45 am]
BILLING CODE 4160-01-P


