[Federal Register Volume 76, Number 75 (Tuesday, April 19, 2011)]
[Notices]
[Pages 21910-21911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9431]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0407]


Ivyl W. Wells: 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 Ivyl W. Wells, MD from providing services in any 
capacity to a person that has an approved or pending drug product 
application. FDA bases this order on a finding that Dr. Wells was 
convicted of multiple felonies under Federal law for conduct relating 
to the regulation of a drug product under the FD&C Act. Dr. Wells was 
given notice of the proposed permanent debarment and an opportunity to 
request a hearing within the timeframe prescribed by regulation. Dr. 
Wells failed to respond. Dr. Well's failure to respond constitutes a 
waiver of his right to a hearing concerning this action.

DATES: This order is effective April 19, 2011.

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, 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 otherwise 
relating to the regulation of any drug product under the FD&C Act.
    On July 12, 2006, Dr. Wells pleaded guilty to, among other things, 
mail fraud

[[Page 21911]]

in violation of 18 U.S.C. 1341 and 1346, adulterating a drug while held 
for sale, in violation of 21 U.S.C. 331(k) and 333(a)(2), and 
misbranding a drug while held for sale, in violation of 21 U.S.C. 
331(k) and 333(a)(2). On December 11, 2006, the U.S. District Court for 
the District of Idaho entered judgment against him.
    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 those convictions is as follows: 
Dr. Wells was a physician licensed by the Idaho State Board of Medicine 
and he owned and operated the Skinovative Laser Center. Between late 
2003 and early 2004, Dr. Wells attended training sponsored by TRI-toxin 
International (TRI), an Arizona corporation. During the TRI seminar he 
learned that the TRI Botulinum Toxin Type A (TRI-toxin) was not 
approved for use in humans. Beginning in February 2004, Wells began 
ordering TRI-toxin for use in treatments in human patients at his 
office. The TRI-toxin came with invoices and labels on the vials of 
toxin that stated the product was ``for research purposes only, not for 
human use.'' Dr. Wells mixed the TRI-toxin with BOTOX/BOTOX Cosmetic, 
causing the drug to become adulterated in violation of 21 U.S.C. 331(k) 
and 333(a)(2), and then he injected the mixture into patients, 
representing the injection as BOTOX/BOTOX Cosmetic.
    From February through November 2004, Dr. Wells defrauded 
approximately 200 patients who received injection treatments intended 
to reduce wrinkles. Dr. Wells defrauded patients by representing and 
selling the Botulinum toxin mixture as BOTOX/BOTOX Cosmetic. Patients 
injected with the Botulinum toxin mixture received pre-treatment 
consultations during which they were informed that they were receiving 
BOTOX/BOTOX Cosmetic and during which they were never informed that 
they would be injected with a Botulinum toxin mixture not approved for 
use in humans. Patients injected also signed a consent form entitled 
``Botox Consent form'' and were told by Skinovative employees that they 
were receiving BOTOX/BOTOX Cosmetic. Patients who received the 
Botulinum toxin mixture were charged prices for treatments that were 
the same as, or similar to, patients who had received BOTOX/BOTOX 
Cosmetic. Dr. Wells misrepresentation of the Botulinum toxin mixture as 
BOTOX/BOTOX Cosmetic resulted in the drug being misbranded in violation 
of 21 U.S.C. 331(k) and 333(a)(2).
    As a result of his convictions, on November 22, 2010, FDA sent Dr. 
Wells a notice by certified mail proposing to permanently debar him 
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. Wells 
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. Wells an opportunity to request a hearing, providing him 30 
days from the date of receipt of the letter in which to file the 
request, and advised him that failure to request a hearing constituted 
a waiver of the opportunity for a hearing and of any contentions 
concerning this action. Dr. Wells failed to respond within the 
timeframe prescribed by regulation and has, therefore, waived his 
opportunity for a hearing and waived any contentions concerning his 
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 him (Staff Manual Guide 1410.35), finds that 
Ivyl W. Wells has been convicted of a felony 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. Wells 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), (c)(2)(A)(ii), (c)(2)(B), 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. Wells in any capacity during Dr. Well'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. Wells provides services in any capacity 
to a person with an approved or pending drug product application during 
his period of debarment he 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. Wells during his period of debarment (section 
306(c)(1)(B) of the FD&C Act).
    Any application by Dr. Wells for special termination of debarment 
under section 306(d)(4) of the FD&C Act should be identified with 
Docket No. FDA-2010-N-0407 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 28, 2011.
Howard Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-9431 Filed 4-18-11; 8:45 am]
BILLING CODE 4160-01-P