[Federal Register Volume 78, Number 220 (Thursday, November 14, 2013)]
[Notices]
[Pages 68455-68459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-27186]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2000-N-0110]
Bruce I. Diamond; 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 Dr. Bruce I.
Diamond's request for a hearing and is issuing an order under the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Dr.
Diamond for 10 years from providing services in any capacity to a
person who has an approved or pending drug product application. FDA
bases this order on findings that Dr. Diamond was convicted of felonies
under State 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, was convicted of felonies involving fraud,
and was a material participant in acts forming the basis of a
conviction that subjects another person to debarment. In determining
the appropriateness and length of Dr. Diamond's debarment period, FDA
has evaluated the relevant considerations listed in the FD&C Act. Dr.
Diamond has failed to file with the Agency information and analysis
sufficient to create a basis for a hearing concerning this action.
DATES: This order is effective November 14, 2013.
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: G. Matthew Warren, Office of
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301-796-4613.
SUPPLEMENTARY INFORMATION:
I. Background
On December 16, 1997, Dr. Diamond pled guilty to 53 State criminal
offenses, including felonies, in the Superior Court for the County of
Richmond, Georgia, and the court subsequently entered judgment against
him. The offenses in the Official Code of Georgia to which
[[Page 68456]]
Dr. Diamond pled guilty included 16 counts of theft by taking (section
16-8-2), 10 counts of theft of services (section 16-8-5), 2 counts of
written false statements (section 16-10-20), 8 counts of acquiring a
controlled substance by misrepresentation (section 16-13-43), 8 counts
of prescribing or ordering dangerous drugs (section 16-13-78.1), 7
counts of prescription of controlled substances (section 16-13-41(f)),
1 count of practicing medicine without a license (section 43-34-26),
and 1 count of bribery (section 16-10-2). On February 10, 1999, in a
separate proceeding, Dr. Diamond consented to disqualification from
receiving investigational new drugs under Sec. 312.70(b) (21 CFR
312.70(b)).
Dr. Diamond, who holds a doctorate in pharmacology but not a
medical degree, was a professor on the faculty of the Medical College
of Georgia (MCG), a unit of the Board of Regents of the University
System of Georgia. Dr. Diamond collaborated with a colleague there,
Richard Borison, M.D., Ph.D., to manage clinical trials for various
drug companies. Without the knowledge or consent of MCG, Drs. Diamond
and Borison used MCG and other government-owned facilities and State
employees to conduct the clinical trials but diverted the funds paid by
the study sponsors for their own gain, without compensating the
university system. Although Dr. Diamond is not a physician, he managed
medical aspects of the clinical trials. In that capacity, he signed Dr.
Borison's name on prescriptions for controlled substances and other
drugs the State defined as dangerous. During the course of one clinical
trial, Drs. Borison and Diamond bribed an employee not to report to MCG
an attempted suicide by one of the study subjects.
By notice dated November 26, 2002, FDA proposed to debar Dr.
Diamond for 10 years from providing services in any capacity to a
person having an approved or pending drug product application. The
notice explained that the proposal was based on three separate grounds:
(1) Dr. Diamond was convicted of felonies under State law for conduct
relating to the development or approval, including the process for
development or approval, of any drug product or otherwise relating to
the regulation of drug products under the FD&C Act, and the type of
conduct serving as the basis of his convictions undermines the process
for the regulation of drugs (section 306(b)(2)(B)(i)(I) of the FD&C Act
(21 U.S.C. 335a(b)(2)(B)(i)(I))); (2) Dr. Diamond was convicted of
felonies involving bribery, fraud, and false statement, and, on the
basis of the convictions and other information, demonstrated a pattern
of conduct sufficient to find that there is reason to believe that he
may violate requirements under the FD&C Act relating to drug products
(section 306(b)(2)(B)(ii)(I); and (3) Dr. Diamond materially
participated in acts that were the basis of Dr. Borison's conviction of
offenses subjecting Dr. Borison to debarment under section
306(b)(2)(B)(ii) and Dr. Diamond's participation, and other
information, demonstrate a pattern of conduct sufficient to find that
there is reason to believe that he may violate requirements under the
FD&C Act relating to drug products (section 306(b)(2)(B)(iii)). The
notice to Dr. Diamond also outlined findings with respect to four
factors that were considered in determining the appropriateness and
period of debarment, as provided in section 306(c)(3) of the FD&C Act:
(1) The nature and seriousness of the offense, (2) the nature and
extent of management participation in the offense, (3) the nature and
extent of voluntary steps to mitigate the impact on the public, and (4)
prior convictions under the FD&C Act or other acts involving matters
within the jurisdiction of FDA.
By letter dated January 2, 2003, through counsel, Dr. Diamond
requested a hearing on the proposal to debar. On February 17, 2004,
after FDA granted him extensions, Dr. Diamond submitted a ``final
response'' in support of his request for a hearing on the proposal to
debar. In his response, Dr. Diamond argues: (1) That his consent
agreement for disqualification under Sec. 312.70(b) precludes his
debarment, (2) that he is innocent of the charge of bribery, (3) that
he is innocent of the charges involving drug prescribing, (4) that
assertions that he used unqualified personnel to staff clinical trials
are without justification or support, (5) that research subject safety
was not compromised under his supervision, and (6) that he did not
serve in a managerial role for the criminal conduct because Dr. Borison
exercised control over him at all times.
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 Sec. 12.24(b)
(21 CFR 12.24(b))).
The Chief Scientist has considered Dr. Diamond'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. Diamond presents six issues
that we will presume are intended to call into question whether he is
subject to debarment--and, if so, whether FDA should debar him--on the
basis of any of the three grounds, section 306(b)(2)(B)(i)(I),
(b)(2)(B)(ii)(I), and (b)(2)(B)(iii) of the FD&C Act, upon which FDA
relied. We therefore address each of his arguments as a challenge to
the grounds for debarment or to FDA's conclusions regarding the
considerations in section 306(c)(3) of the FD&C Act, as appropriate.
A. Disqualification Consent Agreement
Dr. Diamond first argues that the consent agreement for his
disqualification from receiving investigational drugs under Sec.
312.70(b) precludes his debarment under section 306 of the FD&C Act. In
support, he contends that the consent agreement ``should have precluded
any further administrative action against [him].''
The consent agreement states that the ``agreement closes FDA's
administrative proceedings in the present matter'' (emphasis added). A
debarment action under section 306 of the FD&C Act is an entirely
separate matter from disqualification proceedings. FDA has the
authority to disqualify a researcher from conducting clinical testing
of new drugs when it determines that the researcher has repeatedly or
deliberately not followed regulations intended to protect study
subjects and ensure data integrity. (See Sec. 312.70(a).) FDA also may
debar from the drug industry individuals involved in certain conduct.
Once an individual has been debarred, he may no longer provide services
in any capacity for anyone with a drug product application that is
approved or pending at FDA. (See section 306(a) and (b) of the FD&C
Act.)
Furthermore, the consent agreement itself does not foreclose other
types of administrative actions, such as debarment under section 306 of
the FD&C Act. Finally, there is no statutory basis for concluding that
the Agency's decision to disqualify Dr. Diamond from receiving
investigational drugs under a separate process precludes his debarment.
Accordingly, we conclude that there is no genuine and substantial issue
of fact for resolution at a hearing and that the consent agreement
regarding Dr. Diamond's disqualification does not prevent his
debarment. (See Sec. 12.24(b)(1).)
[[Page 68457]]
B. Debarment Under Section 306(b)(2)(B)(i)(I) or 306(b)(2)(B)(ii)(I) of
the FD&C Act
Dr. Diamond's next two arguments focus on the conduct underlying
his convictions for bribing an employee not to report an attempted
suicide by a study subject and unlawfully acquiring and prescribing
controlled substances and dangerous drugs. Dr. Diamond does not deny
that he was convicted of those offenses, nor does he dispute that this
type of conduct subjects him to permissive debarment under the FD&C
Act. Rather, he argues that he is innocent of the charges and that
``due to his need to reach a plea agreement with the State of Georgia
to the charges that he misappropriated money from the State, he entered
in to a complex and not wholly supported in fact plea agreement'' and
he ``accepted perhaps too much when he pled guilty.''
Section 306(b)(2)(B)(i)(I) of the FD&C Act provides FDA with
authority to debar an individual who has been convicted of certain
State felonies, if the Agency finds that the type of conduct serving as
the basis for the conviction undermines the process for the regulation
of drugs. The relevant factual issues are whether Dr. Diamond was, in
fact, convicted of a felony under State law for conduct relating to the
development or approval of a drug product or otherwise relating to the
regulation of drug products under the FD&C Act and whether that type of
conduct undermines the process for the regulation of drugs. Dr. Diamond
does not dispute that he pled guilty to bribery and unlawful
prescriptions for controlled substances and dangerous drugs or that
this type of conduct undermines the process for the regulation of
drugs. Dr. Diamond has therefore failed to show that a genuine and
substantial factual dispute exists with respect to FDA's finding that
he is subject to debarment under section 306(b)(2)(B)(i)(I) of the FD&C
Act.
In the alternative, section 306(b)(2)(B)(ii)(I) of the FD&C Act
provides FDA with authority to debar an individual who has been
convicted of a felony involving, among other things, bribery, false
statements, or fraud, if the Agency finds that the individual has
demonstrated a pattern of conduct sufficient to find that there is
reason to believe he may violate requirements under the FD&C Act
relating to drug products. The relevant factual issues are whether Dr.
Diamond was convicted of a felony involving bribery, false statements,
or fraud and whether he has demonstrated a pattern of conduct
sufficient to find that there is reason to believe he may violate
requirements under the FD&C Act relating to drug products. Dr. Diamond
does not dispute that he pled guilty to felonies involving bribery,
false statement, and fraud, namely theft of over $10 million from MCG
by an 8-year pattern of deception, bribing an employee, making written
false statements, acquiring controlled substances by misrepresentation,
prescribing dangerous drugs and controlled substances while not being a
registered practitioner, and practicing medicine without a license. FDA
further determined that the type of conduct underlying Dr. Diamond's
felony convictions, which were based on the 8-year conspiracy to
defraud MCG through a scheme involving clinical studies, demonstrated
``a pattern of conduct sufficient to find that there is reason to
believe [Dr. Diamond] may violate requirements relating to drug
products again.'' This determination was based on the nature of the
conduct underlying the offenses to which Dr. Diamond pled guilty. Dr.
Diamond has therefore failed to show that a genuine and substantial
factual dispute exists with respect to FDA's finding that he is subject
to debarment under section 306(b)(2)(B)(ii)(I) of the FD&C Act.
Section 306(l) of the FD&C Act includes in its definition of a
conviction, a guilty plea. Accordingly, Dr. Diamond's arguments
regarding the factual circumstances underlying his plea fail to raise a
genuine and substantial issue of fact as to whether he was convicted of
a felony under State 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 or whether he was convicted of a felony
involving bribery, false statements, or fraud. Dr. Diamond contends
that his plea agreement was ``not wholly supported in fact.'' In his
Written Plea of Guilty, however, Dr. Diamond states that ``of my own
free will I want to plead guilty today to the offenses [enumerated] . .
. know and understand that I do not have to say, sign, or do anything
that will show or tend to show that I am guilty unless I want to . . .
My decision to plead guilty is freely and voluntarily made . . . I did
in fact commit the offenses of which I am charged. I am in fact guilty
as charged in the indictment and am in fact guilty of the charges I am
pleading guilty to.'' He also stated that he was advised by competent
counsel regarding his constitutional and due process rights. He was
examined by the court during a lengthy plea colloquy. Under these
circumstances, and in light of the court's acceptance of his guilty
plea, Dr. Diamond's allegations that he was actually innocent of the
offenses and that he signed a plea agreement that was not wholly
truthful are insufficient to create a genuine and substantial issue of
fact for resolution at a hearing. (See Sec. 12.24(b)(1) and (b)(2).)
Therefore, Dr. Diamond is subject to debarment.
C. Debarment Under Section 306(b)(2)(B)(iii) of the FD&C Act
Finally, FDA found that Dr. Diamond is subject to debarment under
section 306(b)(2)(B)(iii) of the FD&C Act for his material
participation in the acts that resulted in another's conviction for an
offense described in section 306(b)(2)(B)(ii)(I) and that on that
basis, Dr. Diamond had demonstrated a pattern of conduct sufficient to
support a belief that he would violate requirements under the FD&C Act
relating to drug products. On September 30, 2003, FDA debarred Dr.
Diamond's co-conspirator, Dr. Borison, under section
306(b)(2)(B)(ii)(I) of the FD&C Act, for his conviction of felonies
under State law for racketeering, theft, and false statements and
representations. (See Richard L. Borison; Debarment Order, 68 FR 56298
(September 30, 2003).) Dr. Diamond does not deny his material
participation in the conduct that led to Dr. Borison's conviction. In
particular, he does not deny participating with Dr. Borison in the
theft of over $10 million from MCG via an 8-year pattern of deception
involving clinical trials. Furthermore, he does not dispute that his
behavior demonstrates a pattern of conduct sufficient to support a
finding that he would violate requirements under the FD&C Act relating
to drug products. Dr. Diamond has therefore failed to show that a
genuine and substantial factual dispute exists with respect to FDA's
finding that he is subject to debarment under section 306(b)(2)(B)(iii)
of the FD&C Act.
D. Debarment Considerations
Next, we construe Dr. Diamond's arguments regarding his innocence
of the charges of bribery and unlawful prescriptions to be challenges
to FDA's findings with respect to the debarment considerations of
section 306(c)(3) of the FD&C Act. Dr. Diamond's arguments regarding
the training and qualifications of the staff he oversaw as part of his
criminal scheme and the safety of the subjects who participated in the
clinical studies also seem to be directed at those findings. As noted
previously, he also challenges FDA's finding that he participated as a
manager in the offenses involved because, he claims, Dr. Borison
[[Page 68458]]
controlled him and masterminded the entire criminal operation.
Section 306(c)(3) of the FD&C Act requires that FDA consider,
``where applicable,'' certain factors ``[i]n determining the
appropriateness and the period of debarment'' for any permissive
debarment. The proposal to debar Dr. Diamond set forth 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).
In its proposal to debar, FDA presented factual findings relevant
to each of the considerations. FDA determined, under section
306(c)(3)(A) of the FD&C Act, that the nature and seriousness of Dr.
Diamond's offenses weighed in favor of debarment because of the scope
of his criminal conduct, his prescription of drugs without a
practitioner's license, and his direction of inadequately trained staff
to perform medical procedures, creating a risk of injury. The Agency
found, under section 306(c)(3)(B) of the FD&C Act, that Dr. Diamond's
management participation in the offenses weighed in favor of debarment.
The Agency found that Dr. Diamond was a manager in that he ``plann[ed]
. . ., directed, and initiated the conduct underlying [his]
conviction'' and ``directed other MCG employees to recruit subjects and
participate in the conduct of the clinical studies.'' Under section
306(c)(3)(C) of the FD&C Act, the Agency determined that, although Dr.
Diamond cooperated with the authorities once they discovered his
criminal scheme, he did not ``promptly disclose to authorities all
wrongdoing'' and exhibited a wanton disregard for the public health by
bribing an employee to remain silent about a suicide attempt. This
factor also was found to weigh in favor of disbarment. Finally,
relating to section 306(c)(3)(F) of the FD&C Act, FDA noted that the
Agency is unaware of any prior convictions under the FD&C Act, a
favorable factor.
Dr. Diamond first appears to challenge these findings by arguing
that he is actually innocent of the bribery and unlawful prescriptions
charges. As noted previously, however, his claims of actual innocence
do not create a genuine and substantial issue of fact, as they must to
justify a hearing under Sec. 12.24(b). Dr. Diamond pled guilty to
those offenses in Federal Court, and he is bound by his guilty pleas,
notwithstanding his current arguments that he pled guilty to those
offenses only for strategic reasons.
Dr. Diamond also contests the Agency's characterization of the
conduct underlying his criminal convictions, as well as his material
participation in the offenses committed by Dr. Borison. However, in
pleading guilty to 52 criminal offenses, Dr. Diamond admitted to
certain conduct. The conduct to which he admitted during the plea
colloquy included overseeing a staff of nine employees to assist in
running the clinical trials, bribing an employee not to report an
adverse event, and prescribing controlled substances without a medical
license. The offenses to which Dr. Diamond pled guilty stemmed from an
8-year scheme to deceive a medical college and his concurrent disregard
for the protection of patients afforded by State laws.
By contending that the employees he oversaw did, in fact, have
adequate training in drawing blood and that his conduct did not
compromise the safety of any patients, Dr. Diamond is challenging FDA's
proposed findings regarding the nature and seriousness of any offenses
involved under section 306(c)(3)(A) of the FD&C Act and the nature and
extent of voluntary steps taken to mitigate the effect on the public
under section 306(c)(3)(C). Even assuming, as Dr. Diamond now argues,
that the nine employees he oversaw had received adequate training in
drawing blood and that no patient was actually harmed by Dr. Diamond's
conduct, the 8-year scheme in which he participated still evinces both
a clear disregard for the laws designed to protect patients and the
public at large and a willingness to commit fraud in furtherance of his
own financial gain. Dr. Diamond had 8 years to voluntarily mitigate the
effects of his wrongdoing but failed even to modify his behavior to
protect the public. Furthermore, Dr. Diamond's arguments that he did
not compromise the safety of his patients are belied by his convictions
for violating numerous State criminal statutes clearly aimed at
protecting patients, such as practicing medicine without a license and
unlawfully acquiring and prescribing controlled or dangerous drugs. In
short, given the scope of Dr. Diamond's conduct, his current claims
regarding the training of his employees and the safety of his patients
are inadequate to create a genuine and substantial issue of fact with
respect to the considerations in sections 306(c)(3)(A) and (c)(3)(C)
or, more generally, the appropriateness or period of his proposed
debarment.
Finally, Dr. Diamond challenges the Agency's findings under section
306(c)(3)(B) of the FD&C Act that he participated as a manager in his
offenses by arguing that Dr. Borison exercised control over him and
masterminded the criminal scheme. As noted previously and as outlined
in the indictment to which he pled guilty, however, Dr. Diamond served
a managerial role in the offenses. Even assuming, as Dr. Diamond now
alleges, that he was at all times second in command to Dr. Borison, Dr.
Diamond admitted during his criminal proceedings that he oversaw a
staff of a least nine employees in implementing the criminal scheme of
which he was convicted. Furthermore, he does not dispute the findings
in the proposal to debar that he, along with Dr. Borison, was involved
in planning and initiating the criminal scheme. Dr. Diamond's claim
that he was ``at all times subservient to Dr. Borison'' fails to
present a genuine and substantial issue of fact with respect to the
consideration in section 306(c)(3)(B) of the FD&C Act or, more
generally, the appropriateness or period of his proposed debarment.
Consistent with the findings in the proposal to debar, the Chief
Scientist finds, based on the undisputed record before the Agency, that
debarment of Dr. Diamond for two consecutive terms of 5 years is
appropriate. The considerations in section 306(c)(3)(A), (c)(3)(B), and
(c)(3)(C) of the FD&C Act weigh in favor of debarring Dr. Diamond for
at least 10 years. Although Dr. Diamond appears to have no previous
criminal convictions related to matters within the jurisdiction of FDA
(see section 306(c)(3)(F) of the FD&C Act), that consideration does not
counter to a sufficient degree the remaining considerations to warrant
decreasing the periods of debarment. Of particular note are the nature
and seriousness of Dr. Diamond's offenses. As detailed previously, Dr.
Diamond pled guilty to an 8-year criminal scheme reflecting not only,
as found in the proposal to debar, ``a wanton disregard for the public
health,'' but also a willingness to defraud a government body over a
sustained period of time. Reducing the period of debarment from 10
years to some lesser amount of time based on Dr. Diamond's lack of
prior criminal convictions would be inconsistent with protecting the
public health and thus the remedial purpose of the Agency's debarment
authority under section 306 of the FD&C Act.
II. Findings and Order
Therefore, the Chief Scientist, under section 306(b)(2)(B)(i)(I) of
the FD&C
[[Page 68459]]
Act, or in the alternative section 306(b)(2)(B)(ii)(I) and
(b)(2)(B)(iii) and under authority delegated to him, finds that Dr.
Diamond is subject to debarment. The Chief Scientist has considered the
relevant factors listed in section 306(c)(3) of the FD&C Act and
determined that debarment for 10 years is appropriate.
As a result of the foregoing findings, Dr. Diamond is debarred for
10 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)
(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. Diamond, in any capacity during his
period of debarment, will be subject to civil money penalties. If Dr.
Diamond, 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. Diamond during his period of
debarment.
Any application by Dr. Diamond for termination of debarment under
section 306(d) of the FD&C Act should be identified with Docket No.
FDA-2000-N-0110 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: November 4, 2013.
Jesse L. Goodman,
Chief Scientist.
[FR Doc. 2013-27186 Filed 11-13-13; 8:45 am]
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