[Federal Register Volume 76, Number 47 (Thursday, March 10, 2011)]
[Notices]
[Page 13192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5498]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0479]


Mark E. Van Wormer: 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 Mark E. Van Wormer, 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. Van 
Wormer was convicted of a felony under Federal law for conduct relating 
to the regulation of a drug product under the FD&C Act. Dr. Van Wormer 
was given notice of the proposed permanent debarment and an opportunity 
to request a hearing within the timeframe prescribed by regulation. In 
a January 1, 2011, letter to FDA, Dr. Van Wormer notified FDA that he 
did not plan to seek a hearing and therefore has waived his right to a 
hearing concerning this action.

DATES: This order is effective March 10, 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 December 13, 2007, the U.S. District Court, District of New 
Mexico, entered judgment against Dr. Van Wormer for felony misbranding 
a drug while held for sale in violation of 21 U.S.C. 333(a)(2), 331(k) 
and 352(i)(3).
    FDA's finding that debarment is appropriate is based on the felony 
conviction referenced herein for conduct relating to the regulation of 
a drug product. The factual basis for the conviction is as follows: Dr. 
Van Wormer is a physician licensed by the New Mexico State Board of 
Medicine, and he owned and operated the Union County Medical Center, 
also known as the Union County Medical, Diagnostic Imaging and Laser 
Surgery Center, PC, and the Physicians GreatSkin[reg] Clinic.
    From on or about January 13, 2004, through on or about November 9, 
2004, Dr. Van Wormer advertised the use of Allergan's approved BOTOX 
for use in treatment of forehead wrinkles. However, during that time he 
knowingly used TRI-toxin, an unapproved botulinum toxin type A product, 
that he purchased from Toxin Research International, Inc. (TRI), a 
company in Tucson, AZ.
    Dr. Van Wormer purchased approximately 20 vials of the TRI-toxin, 
which he injected into his patients. He did not inform his patients 
that they were being injected with an unapproved substance, and 
patients were charged as if they were receiving the approved drug 
product. Dr. Van Wormer injected approximately 120 patients with the 
unapproved TRI-toxin.
    As a result of his convictions, on December 17, 2010, FDA sent Dr. 
Van Wormer 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. Van 
Wormer was convicted of a felony under Federal law for conduct relating 
to the regulation of a drug product under the FD&C Act. The proposal 
also offered Dr. Van Wormer 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. Van Wormer submitted a letter 
dated January 1, 2011, acknowledging receipt of the proposal to debar 
and noting that he did not plan to seek a further hearing regarding the 
matter and thereby has waived his opportunity for a hearing and 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 the Director (Staff Manual Guide 1410.35), finds 
that Mark E. Van Wormer 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 and based on his notification 
of acquiescence, Dr. Van Wormer 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) 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. Van Wormer, in any capacity during Dr. Van Wormer'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. Van Wormer 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. Van Wormer during his period 
of debarment (section 306(c)(1)(B) of the FD&C Act).
    Any application by Dr. Van Wormer for special termination of 
debarment under section 306(d)(4) of the FD&C Act should be identified 
with Docket No. FDA-2010-N-0479 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: February 16, 2011.
Howard Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-5498 Filed 3-9-11; 8:45 am]
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