[Federal Register Volume 76, Number 206 (Tuesday, October 25, 2011)]
[Notices]
[Pages 66072-66073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27509]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0159]


Albert Ronald Cioffi: 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 
Albert Cioffi, MD for 5 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. Cioffi 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. Cioffi was given notice of the proposed debarment and an 
opportunity to request a hearing within the timeframe prescribed by 
regulation. Dr. Cioffi failed to request a hearing. Dr. Cioffi's 
failure to request a hearing constitutes a waiver of his right to a 
hearing concerning this action.

DATES: This order is effective October 25, 2011.

ADDRESSES: Submit applications for 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, Division of Compliance 
Policy, Food and Drug Administration, 12420 Parklawn Dr., Element 
Bldg., rm. 4144, 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 a drug product 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 January 9, 2008, based upon a plea of guilty to one count of 
misbranding a drug while held for sale after shipment in interstate 
commerce, in violation of 21 U.S.C. 331(k), 333(a)(1), and

[[Page 66073]]

352(i)(3), judgment was entered against Dr. Cioffi in the United States 
District Court for the Southern District of Florida.
    FDA's finding that debarment is appropriate is based on the 
misdemeanor conviction referenced herein. The factual basis for the 
conviction is as follows: During 2004, Dr. Cioffi was a physician 
licensed to practice in the State of Florida. In February 2004, Dr. 
Cioffi became the medical doctor of Body Rx, a medical office located 
in Boca Raton, FL. In July 2004, Dr. Cioffi became the sole owner of 
Body Rx which specialized in cosmetic procedures, including the 
treatment of forehead wrinkles. When Dr. Cioffi began working at Body 
Rx, he learned that Body Rx had been treating patients for forehead 
wrinkles with the unapproved drug derived from Botulinum Toxin Type A 
(TRI-toxin), sold by Toxin Research International (TRI), a company in 
Tuscon, AZ. Dr. Cioffi spoke with TRI representatives and learned that 
TRI-toxin was not approved by FDA for treatment of facial wrinkles. 
Nonetheless, Dr. Cioffi continued to purchase and use the unapproved 
drug from TRI. On four separate occasions between February and November 
of 2004, Body Rx purchased a total of eight vials of unapproved TRI-
toxin at Dr. Cioffi's direction. Dr. Cioffi used the unapproved drug to 
inject approximately 30 patients and never informed these patients that 
they were receiving an unapproved version of Botulinum Toxin Type A. 
Instead, Dr. Cioffi told patients that they were purchasing and being 
injected with the approved BOTOX Cosmetic, and he indicated in these 
patients' medical records that they were receiving the FDA approved 
BOTOX Cosmetic.
    From in or about February 2004, and continuing through in or about 
November 2004, in the Southern District of Florida, and elsewhere, Dr. 
Cioffi did misbrand a drug, namely Botulinum Toxin Type A distributed 
by TRI, while it was held for sale and after shipment in interstate 
commerce, in that he offered the unapproved Botulinum Toxin Type A for 
sale by injection to patients under the name of another drug, all in 
violation of 21 U.S.C. 331(k), 333(a)(1), 352(i)(3), and 18 U.S.C. 2.
    As a result of his conviction, on June 1, 2011, FDA sent Dr. Cioffi 
a notice by certified mail proposing to debar him for 5 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. Cioffi was 
convicted of a misdemeanor under Federal law for conduct relating to 
the regulation of a drug product 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. Cioffi 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. Cioffi failed to request a hearing 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 Acting 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 Albert R. Cioffi 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. Cioffi is debarred for 5 
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 sections 306(c)(1)(B), (c)(2)(A)(iii), and 201(dd) of the 
FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(iii), and 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. Cioffi, in any capacity during Dr. 
Cioffi'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. Cioffi 
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. Cioffi 
during his period of debarment (section 306(c)(1)(B) of the FD&C Act).
    Any application by Dr. Cioffi for termination of debarment under 
section 306(d)(1) of the Act (21 U.S.C. 355a(d)(1)) should be 
identified with Docket No. FDA-2011-N-0159 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 11, 2011.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-27509 Filed 10-24-11; 8:45 am]
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