[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Notices]
[Pages 11995-11998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05046]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0299]


Douglas M. Hargrave; 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. Douglas M. Hargrave (Dr. Hargrave), and 
is issuing an order under the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) debarring Dr. Hargrave for 2 years 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. Hargrave 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. Hargrave's debarment, FDA has considered the relevant factors 
listed in the FD&C Act. Dr. Hargrave 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. Hargrave, 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. Hargrave's colleague in the same medical 
practice, The Plastic Surgery Group (TPSG), 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. 
Hargrave then proceeded to inject approximately 25 patients, who 
believed they were being injected with BOTOX, with TRI-toxin as a 
substitute.
    Dr. Hargrave is subject to debarment based on a finding, under 
section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 
335a(b)(2)(B)(i)(I)): (1) That he

[[Page 11996]]

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 notice to Dr. Hargrave dated November 30, 2010, 
FDA's Office of Regulatory Affairs (ORA) proposed to debar him for 4 
years from providing services in any capacity to a person having an 
approved or pending drug product application.
    In a letter dated December 30, 2010, through counsel, Dr. Hargrave 
requested a hearing on the proposal. In his request for a hearing, Dr. 
Hargrave acknowledges his conviction under Federal law, as alleged by 
FDA. By letter dated January 28, 2011, Dr. Hargrave submitted materials 
and arguments in support of his request. Dr. Hargrave acknowledges that 
he was convicted of a Federal misdemeanor, as found in the proposal to 
debar, but argues that he should not be debarred for reasons related to 
the factual basis set forth in the proposal to debar. In particular, 
with respect to the considerations for determining the appropriateness 
and period of debarment under section 306(c)(3) of the FD&C Act, he 
argues that there are genuine and substantial issues of fact for 
resolution at a hearing, namely factual issues bearing on whether he 
participated in or even knew of certain conduct that resulted in his 
violation of the FD&C Act.
    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 or the action requested (see 21 CFR 
12.24(b)).
    The Chief Scientist has considered Dr. Hargrave's arguments, as 
well as the proposal to debar itself, and concludes that, although Dr. 
Hargrave has failed to raise a genuine and substantial issue of fact 
requiring a hearing, the appropriate period of debarment is 2 years.

II. Arguments

    In support of his hearing request, Dr. Hargrave first asserts that 
he is not subject to debarment under section 306(b)(2)(B)(i)(I) of the 
FD&C Act. He contends that he pled guilty to a misdemeanor violation of 
the FD&C Act (see section 303(a)(1) of the FD&C Act), which is a strict 
liability offense, and that thus there was no demonstration or 
admission of criminal intent or knowledge underlying the conviction. 
Dr. Hargrave concludes, therefore, that the conduct underlying his 
conviction did not undermine the process for the regulation of drugs.
    Section 306(b)(2)(B)(i)(I) of the FD&C Act specifically provides 
for the debarment of individuals convicted of Federal misdemeanors 
related to the regulation of drug products under the FD&C Act. Given 
that misdemeanor violations of the FD&C Act themselves are strict 
liability offenses, it stands to reason that criminal intent is not a 
critical component to debar an individual under section 
306(b)(2)(B)(i)(I). During his criminal proceedings, Dr. Hargrave 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 an unapproved drug, TRI-toxin, for sale as an approved drug 
product, BOTOX. Dr. Hargrave's conduct 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. Hargrave is, in fact, subject to debarment under 
section 306(b)(2)(B)(i)(I) of the FD&C Act.
    Dr. Hargrave next challenges the manner in which ORA applied the 
considerations under section 306(c)(3) of the FD&C Act in determining 
the appropriateness and period of his debarment. In the proposal to 
debar Dr. Hargrave, ORA stated that there are four applicable 
considerations under section 306(c)(3) of the FD&C Act: (1) The nature 
and seriousness of his offense under section 306(c)(3)(A); (2) the 
nature and extent of management participation in the offense under 
section 306(c)(3)(B); (3) the nature and extent of voluntary steps 
taken to mitigate the impact on the public under section 306(c)(3)(C); 
and (4) prior convictions involving matters within the jurisdiction of 
FDA under section 306(c)(3)(F). ORA found with respect to Dr. Hargrave 
that the first two considerations weigh in favor of debarment and noted 
that the third and fourth considerations would be treated as favorable 
factors for him. In making all of its findings under section 306(c)(3) 
FD&C Act, ORA characterized Dr. Hargrave's conduct based on records 
from his criminal proceedings.
    Under section 306(c)(3)(A) of the FD&C Act, in determining the 
appropriateness and period of debarment, FDA considers ``the nature and 
seriousness of the offense involved.'' In the proposal to debar, ORA 
relied on the criminal information to which Dr. Hargrave pled guilty to 
find that the conduct underlying his convictions:

created a risk of injury to consumers due to the use of an 
unapproved drug, undermined [FDA's] oversight of an approved drug 
product by representing that [he] used the approved drug while 
actually substituting an unapproved drug in its place, and seriously 
undermined the integrity of [FDA's] regulation of drug products.

Under section 306(c)(3)(B) of the FD&C Act, ORA also considered the 
``nature and extent of [Dr. Hargrave's] management participation in the 
offense'' and specifically found that he was a corporate principal who 
``pleaded guilty to misbranding TRI-toxin'' and ``participated in the 
[TPSG's] unlawful conduct of administering [an] unapproved drug on 
multiple occasions to patients.'' ORA concluded, therefore, that the 
nature and seriousness of Dr. Hargrave's offenses and the nature and 
extent of management participation were unfavorable factors with 
respect to him.

    Dr. Hargrave counters ORA's findings with respect to those two 
considerations in section 306(c)(3) of the FD&C Act with the following 
arguments: (1) That he did not admit any criminal intent or intentional 
wrongdoing when he pled guilty to a misdemeanor offense under the FD&C 
Act; (2) that, in fact, another physician at TPSG took unilateral 
action in ordering the TRI-toxin and directing a nurse to substitute it 
for BOTOX; (3) that the TRI-toxin vials that they used for injecting 
patients with TRI-toxin were identical to the vials he used for BOTOX 
before the substitution; and (4) that since the conviction for the 
underlying misdemeanor was of an individual, that there was no 
management participation and that, thus, the nature and extent of 
management participation is inapplicable as a factor in determining 
appropriateness and period of debarment. Dr. Hargrave concedes that he 
pled guilty to the misdemeanor offense because he was, in fact, guilty 
of offering TRI-toxin for sale to their patients as BOTOX. He argues, 
however, that the criminal records do not establish any intent or 
knowledge on his part and that thus the conduct underlying his 
conviction does not warrant debarment in light of the considerations in 
section 306(c)(3) of the FD&C Act.
    As noted previously, ORA relied on the records of Dr. Hargrave's 
criminal proceedings for its findings in the proposal to debar. There 
is nothing definitive in the criminal records before FDA to contradict 
Dr. Hargrave's assertions with respect to the nature of his involvement 
in the misdemeanor offense to which he pled guilty. The criminal 
information to which Dr.

[[Page 11997]]

Hargrave pled guilty alleges that TPSG, as opposed to Dr. Hargrave, 
began ordering TRI-toxin for use in the medical practice, and there are 
no allegations that Dr. Hargrave took part in the ordering process. 
Indeed, the proposal to debar states that, as claimed by Dr. Hargrave, 
another physician in the practice, William F. DeLuca, Jr., was 
responsible for authorizing a nurse to substitute TRI-toxin for BOTOX, 
not Dr. Hargrave. At Dr. Hargrave's sentencing hearing, at which six 
other codefendants, including DeLuca, were also sentenced, the 
presiding judge also made clear that he believed DeLuca was the 
physician responsible for making the ``mistake'' that led to the other 
physician's offenses. In addressing DeLuca, the court 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.

In addressing one of the other three physicians who pled guilty under 
circumstances similar to Dr. Hargrave's, the court further stated: 
``There have been disputes on how in the past over who knew what and at 
what point in time. It is clear from the facts in this case that you 
had no knowledge that the substance was anything other than [BOTOX] 
until your discovery of it in November of 2004.''

    In short, consistent with the proposal to debar Dr. Hargrave for 4 
years, the records of his criminal proceedings establish that the 
misdemeanor convictions for the physicians in TPSG other than DeLuca 
were not based on any affirmative involvement in ordering the TRI-toxin 
or substituting the TRI-toxin for BOTOX. Furthermore, in proposing to 
debar Dr. Hargrave for 4 years, ORA did not rely on any findings with 
respect to Dr. Hargrave's intent or knowledge. Rather, citing the 
records of Dr. Hargrave's criminal proceedings, the proposal to debar 
simply rests on Dr. Hargrave's position of authority within TPSG and 
his conduct in misbranding TRI-toxin by administering it to patients 
who believed they were receiving BOTOX. As a result, under Sec.  
12.24(b), there is no genuine and substantial issue of fact raised by 
Dr. Hargrave's arguments for resolution at a hearing.
    As set forth in the proposal to debar and summarized previously, 
Dr. Hargrave 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) of the FD&C Act with respect to the nature and seriousness 
of the offense involved is a favorable factor. As reflected in the 
records of the criminal proceedings, Dr. Hargrave's offense did not 
rest on any intent or knowledge of wrongdoing on his part, nor may such 
intent or knowledge be inferred from the circumstances of his offense 
or the findings in the proposal to debar. Although, as a practicing 
physician, Dr. Hargrave should be expected to take the appropriate 
steps to avoid administering an unapproved new drug to patients or 
misrepresenting the drug being administered, his failure to do so over 
a t10-month period does not warrant considering the nature and 
seriousness of his offense as an unfavorable factor, relative to the 
range of conduct that might underlie a Federal misdemeanor conviction.
    On the other hand, because of Dr. Hargrave's position of authority 
within TPSG and, thus, presumed ability to prevent the series of events 
that resulted in the offense underlying his misdemeanor conviction, the 
nature and extent of management participation in the offense is an 
unfavorable factor, for the purposes of the consideration under 
306(c)(3)(B) of the FD&C Act. Dr. Hargrave asserts that there was no 
management participation, and that, thus, this factor is inapplicable 
because the underlying conviction was of an individual. However, the 
criminal information to which Dr. Hargrave pled guilty alleges that 
TPSG began ordering TRI-toxin for use in the medical practice. It is 
undisputed that Dr. Hargrave is a principal in TPSG, and this is the 
basis for considering the nature and extent of management participation 
as a factor in determining the appropriateness and period of debarment. 
FDA has relied on this factor in other debarment cases where the 
underlying conviction was of an individual (see 78 FR 68455 (November 
14, 2013), 77 FR 27236-01 (May 9, 2012)).
    The limited scope of his direct actions in committing the 
underlying misdemeanor offense does not mitigate the extent of his 
management participation, as established during his criminal 
proceedings and as set out in the proposal to debar. It is true that 
nothing in the criminal proceedings or the proposal to debar reflects 
any involvement by him in the decision to order the TRI-toxin and 
substitute it for BOTOX, and the proposal to debar specifically finds 
that another physician authorized a nurse to place that order. However, 
Dr. Hargrave, as a principal of TPSG, was responsible for failing to 
ensure that there were controls and procedures in place to prevent 
other physicians or a nurse from ordering unapproved drugs for 
administration to patients. His own admitted inaction on that front 
warrants treating his management participation as an unfavorable 
factor.\1\
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    \1\ See United States v. Park, 421 U.S. 658, 673-74 (1975) 
(holding that a high-level manager within a business entity bears a 
responsibility to prevent and correct violations of the FD&C Act).
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    Consistent with the proposal to debar, the record establishes that 
the medical practice of which Dr. Hargrave was a part ultimately took 
voluntary steps to mitigate the effect on the public health from its 
unlawful conduct (see section 306(c)(3)(C) of the FD&C Act). 
Furthermore, it is undisputed that Dr. Hargrave had no previous 
criminal convictions related to matters within the jurisdiction of FDA 
(see section 306(c)(3)(F) of the FD&C Act). Therefore, these will be 
treated as favorable factors. In light of the foregoing four 
considerations, one of which weighs against Dr. Hargrave, debarment for 
2 years is appropriate.

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, finds that Dr. 
Hargrave 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 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 2 
years is appropriate.
    As a result of the foregoing findings, Dr. Hargrave is debarred for 
2 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. Hargrave, in any 
capacity during his period of debarment, will be subject to civil money 
penalties. If Dr. Hargrave, during his period of debarment, provides 
services in any capacity to a

[[Page 11998]]

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. Hargrave during his period of debarment.
    Any application by Dr. Hargrave for termination of debarment under 
section 306(d) of the FD&C Act should be identified with Docket No. 
FDA-2010-N-0299 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. 2015-05046 Filed 3-4-15; 8:45 am]
 BILLING CODE 4164-01-P