[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Notices]
[Pages 12011-12013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05043]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0303]


William F. DeLuca, Jr.; Denial of Hearing; Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is denying a request 
for a hearing submitted by Dr. William F. DeLuca, Jr. and is issuing an 
order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
debarring Dr. DeLuca for 5 years from providing

[[Page 12012]]

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. 
DeLuca 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. In determining the appropriateness 
and period of Dr. DeLuca's debarment, FDA has considered the relevant 
factors listed in the FD&C Act. Dr. DeLuca has failed to file with the 
Agency information and analyses sufficient to create a basis for a 
hearing concerning this action.

DATES: The order is effective March 5, 2015.

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: Nathan Doty, Office of Scientific 
Integrity, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993, 301-796-8556.

SUPPLEMENTARY INFORMATION:

I. Background

    On August 11, 2009, in the U.S. District Court for the Northern 
District of New York, Dr. DeLuca, a physician, pled guilty to a 
misdemeanor under the FD&C Act, namely misbranding a drug in violation 
of sections 301(k), 502(i)(3), and 303(a)(1) of the FD&C Act (21 U.S.C. 
331(k), 352(i)(3), 333(a)(1)) and 18 U.S.C. 2. The basis for this 
conviction was conduct surrounding his injection of patients seeking 
treatment with BOTOX/BOTOX Cosmetic (BOTOX) with a product, TRI-toxin, 
distributed by Toxin Research International, Inc. BOTOX is a biological 
product derived from Botulinum Toxin Type A that is manufactured by 
Allergan, Inc., and was approved by FDA for use on humans for the 
treatment of facial wrinkles in 1991. According to the records of the 
criminal proceedings, Dr. DeLuca directed a nurse to obtain 31 vials of 
TRI-toxin, an unapproved drug product, which was represented by its 
distributor as ``Botulinum Toxin Type A.'' Dr. DeLuca then proceeded to 
inject approximately 62 patients, who believed they were being injected 
with BOTOX, with TRI-toxin as a substitute.
    Dr. DeLuca is subject to debarment based on a finding, under 
section 306(b)(2)(B)(i) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)): 
(1) That he was convicted of a misdemeanor under Federal law relating 
to the regulation of a drug product under the FD&C Act and (2) that the 
type of conduct underlying the conviction undermines the process for 
the regulation of drugs. By letter dated November 30, 2010, FDA 
notified Dr. DeLuca of its proposal to debar him for 5 years from 
providing services in any capacity to a person having an approved or 
pending drug product application.
    In a letter dated December 28, 2010, through counsel, Dr. DeLuca 
requested a hearing on the proposal. In his request for a hearing, Dr. 
DeLuca acknowledges his convictions under Federal law, as alleged by 
FDA. However, he argues that section 306(b)(2)(B)(i) of the FD&C Act, 
which was added by the Generic Drug Enforcement Act (GDEA), does not 
apply to him because he was never involved in the development, 
approval, or regulation of drug products, nor was the conduct 
underlying his conviction related to the development, approval, or 
regulation of drug products.
    We reviewed Dr. DeLuca's request for a hearing and find that Dr. 
DeLuca has not created a sufficient basis for a hearing. Hearings are 
granted only if there is a genuine and substantial issue of fact. 
Hearings will not be granted on issues of policy or law, on mere 
allegations, denials, or general descriptions of positions and 
contentions, or on data and information insufficient to justify the 
factual determination urged (see 21 CFR 12.24(b)).
    The Chief Scientist has considered Dr. DeLuca's arguments and 
concludes that they are unpersuasive and fail to raise a genuine and 
substantial issue of fact requiring a hearing.

II. Arguments

    In support of his hearing request, Dr. DeLuca asserts that section 
306(b)(2)(B)(i)(I) of the FD&C Act does not apply to him because he was 
never involved in the development, approval, or regulation of drug 
products, nor was the underlying conduct of his conviction related to 
those activities. He argues that application of the permissive 
debarment provisions to him expands the intended scope of section 
306(b)(2)(b)(i)(I) of the FD&C Act beyond congressional intent. Dr. 
DeLuca further asserts that the statutory provision is limited to 
conduct that directly or indirectly affects FDA's regulatory efforts 
associated with drug approval, that the intended targets of GDEA are 
those who manufacture and distribute drugs, and that the court's 
decision in Bhutani v. U.S. Food and Drug Administration, 161 Fed. 
Appx. 589, 591 (7th Cir. 2006) and FDA's debarment order for Premchand 
Girdhari (65 FR 3454, January 21, 2000) also expressed this limitation. 
He asserts that, because his conduct did not fall within any such 
activities and he was not a company manufacturing or distributing 
drugs, but merely a physician using a drug, albeit an unapproved drug, 
section 306(b)(2)(B)(i)(I) if the FD&C Act is inapplicable to him.
    During his criminal proceedings, Dr. DeLuca pled guilty to 
misbranding and causing the misbranding of a drug in violation of 
sections 301(k), 502(i)(3) and 303(a)(1) of the FD&C Act by offering 
TRI-toxin, a drug not approved for use, in place of an approved drug 
product, BOTOX. This conduct clearly relates to the regulation of drugs 
under the FD&C Act because it was in direct violation of the FD&C Act. 
The conduct also undermined the process for the regulation of drugs in 
that it permitted an unapproved drug to be substituted for an approved 
drug without the knowledge of the patient. As a result, Dr. DeLuca is 
subject to debarment under section 306(b)(2)(B)(i)(I) of the FD&C Act.
    Dr. DeLuca's narrow interpretation of section 306(b)(2)(B)(i) of 
the FD&C Act, as well as the other provisions added to the statute by 
GDEA, is unpersuasive. Under well-recognized rules of statutory 
construction, the starting point in interpreting a statute is the text 
of the statute itself. (BedRoc Limited LLC. v. United States, 541 U.S. 
176, 183 (2004), on remand, 368 F.3 1149 (9th Cir. 2004)). It is clear 
from section 306(b)(2)(B)(i) of the FD&C Act that the ``regulation of 
drugs'' is not limited to activities related to the approval of drugs. 
If that were the case, there would be no need for the language ``or 
otherwise relating to the regulation of drug products'' as the 
provision already clearly covers approval activities with the language 
``relating to the development, or approval, including the process for 
development or approval.'' Under rules of statutory construction, all 
the words in a statute are to be given meaning and no words or 
provisions are to be rendered superfluous. (Montclair v. Ramsdell, 107 
U.S. 147, 152 (1883), Astoria Federal Savings and Loan Ass'n v. 
Solimino, 501 U.S. 104, 112 (1991).)
    Dr. DeLuca's arguments regarding the legislative history and intent 
of GDEA also are unpersuasive. Dr. DeLuca cites to the House Report for 
the bill passed by the House. However, that bill did not ultimately 
become section 306(b)(2)(B)(i) of the FD&C Act. If the language of the 
statute is clear, there is no need to look outside the statute to its

[[Page 12013]]

legislative history in order to ascertain the statute's meaning. 
(Chamber of Commerce of United States v. Whiting, 131 S. Ct. 1968 
(2011).) Dr. DeLuca's conduct in misbranding Tri-toxin by holding it 
for sale and administering it to patients as the approved drug BOTOX 
clearly relates to FDA's regulation of approved drugs. Likewise, his 
argument that section 306(b)(2)(B)(i) of the FD&C Act could not have 
been intended to cover him because he did not work for a person with a 
pending or approved drug product application when he was convicted or 
that section 306(b)(2)(B)(i) applies to only individuals who 
manufacture and distribute drugs ignores both the plain language of the 
statute and the remedial purpose of the Agency's debarment authority. 
Furthermore, Dr. DeLuca's argument that Bhutani v. U.S. Food and Drug 
Administration, 161 Fed. Appx. 589, 591 (7th Cir. 2006), and FDA's 
debarment order for Premchand Girdhari (65 FR 3454) evidence the 
court's and FDA's view that the statute is to be interpreted to exclude 
him is without merit. Both the court decision and FDA's debarment order 
address the specific fact situations at issue. Both situations involved 
persons who manufactured and distributed drugs. The decision and order 
did not purport to define the full scope of section 306(b)(2)(B)(i) of 
the FD&C Act or hold that conduct such as Dr. DeLuca's was not within 
the scope of the statutory provision.
    Finally, Dr. DeLuca argues that FDA does not typically debar 
physicians for criminal violations of the FD&C Act. FDA has, however, 
debarred several other physicians under section 306(b)(2)(B)(i)(I) of 
the FD&C Act for convictions under the FD&C Act on the basis of similar 
conduct. (See, e.g., 77 FR 27235, May 9, 2012; 76 FR 69272, November 8, 
2011; 76 FR 30947, May 27, 2011; 76 FR 21910, April 19, 2011; 76 FR 
13192, March 10, 2011; 76 FR 11789, March 3, 2011 (debarring physicians 
for felony violations of the FD&C Act for substituting TRI-toxin for 
BOTOX); 77 FR 27236, May 9, 2012; 76 FR 66072, October 25, 2011; 76 FR 
48168, August 8, 2011; 76 FR 37126, June 24, 2011; 76 FR 30946, May 27, 
2011; 76 FR 18556, April 4, 2011; 76 FR 18557, April 4, 2011; 76 FR 
12971, March 9, 2011 (debarring physicians for a misdemeanor violations 
of the FD&C Act for substituting TRI-toxin for BOTOX).
    Dr. DeLuca's arguments do not raise any genuine and substantial 
issue of fact for a hearing. Furthermore, Dr. DeLuca's legal arguments 
do not create a basis for a hearing and, in any event, are 
unpersuasive. Accordingly, the Chief Scientist denies Dr. DeLuca's 
request for a hearing.
    As set forth in the proposal to debar and summarized in this 
document, Dr. DeLuca pled guilty to a misdemeanor under the FD&C Act 
for his role in offering a drug under the name of another. Based on the 
undisputed record before the Agency, the consideration in section 
306(c)(3)(A) and (B) of the FD&C Act with respect to the nature and 
seriousness of the offense and extent in management participation 
involved are unfavorable in light of Dr. DeLuca's conduct in bringing 
the unapproved drug into the medical practice and his management 
position in The Plastic Surgery Group. At Dr. DeLuca's sentencing 
hearing, at which six other codefendants were also sentenced, the 
presiding judge in addressing Dr. DeLuca stated:

And we're here because of your actions and inactions. As I said, 
your mistakes were different in kind and degree from those of your 
colleagues. It was you who brought this drug into the practice, and 
it was your conduct and your failure to check out either the company 
or the drug that you were ordering, as you should have done, your 
negligence in doing that that has brought us here today in the end.

    Consistent with the proposal to debar, the record established that 
the medical practice of which Dr. DeLuca was a part ultimately took 
voluntary steps to mitigate the effect on the public health from its 
unlawful conduct and that Dr. DeLuca had no previous criminal 
convictions related to matters within FDA's jurisdictions. As such, the 
considerations in sections 306(c)(3)(C) and (F) of the FD&C Act will be 
treated as favorable factors.
    In light of the totality of the circumstances underlying the 
foregoing four considerations, the seriousness of the offense and Dr. 
DeLuca's management participation make debarment for 5 years, 
consistent with the proposal to debar, appropriate in spite of the 
favorable factors under 306(c)(3)(C) and (F) of the FD&C Act.

III. Findings and Order

    Therefore, the Chief Scientist, under section 306(b)(2)(B)(i)(I) of 
the FD&C Act and under authority delegated to him by the Commissioner 
of Food and Drugs, finds: (1) That Dr. DeLuca has been convicted of a 
misdemeanor under Federal law for conduct relating to the development 
or approval of a drug product or otherwise relating to the regulation 
of a drug product under the FD&C Act and (2) that the conduct 
underlying the conviction undermines the regulation of drugs. FDA has 
considered the relevant factors listed in section 306(c)(3) of the FD&C 
Act and determined that a debarment of 5 years is appropriate.
    As a result of the foregoing findings, Dr. DeLuca is debarred for 5 
years from providing services in any capacity to a person with an 
approved or pending drug product application under section 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 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) and 21 U.S.C. 321(dd)). 
Any person with an approved or pending drug product application who 
knowingly uses the services of Dr. DeLuca, in any capacity during his 
period of debarment, will be subject to civil money penalties. If Dr. 
DeLuca, during his period of debarment, provides services in any 
capacity to a person with an approved or pending drug product 
application he will be subject to civil money penalties. In addition, 
FDA will not accept or review any abbreviated new drug applications 
submitted by or with the assistance of Dr. DeLuca during his period of 
debarment.
    Any application by Dr. DeLuca for termination of debarment under 
section 306(d) of the FD&C Act should be identified with Docket No. 
FDA-2010-N-0303 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. 
Persons with access to the Internet may obtain documents in the Docket 
at http://www.regulations.gov/.

    Dated: February 24, 2015.
Stephen Ostroff,
Director, Office of the Chief Scientist.
[FR Doc. 2015-05043 Filed 3-4-15; 8:45 am]
 BILLING CODE 4164-01P