[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Notices]
[Pages 49095-49097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21210]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0333]


Richard M. Fleming; Denial of Hearing; Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
denying a request for a hearing submitted by Richard M. Fleming 
(Fleming) and is issuing an order under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) debarring Fleming for 10 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 
Fleming was convicted of two felonies under Federal law that involved 
fraud. Additionally, Fleming has 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. In 
determining the appropriateness and period of Fleming's debarment, FDA 
considered the relevant factors listed in the FD&C Act. Fleming failed 
to file with the Agency information and analyses sufficient to create a 
basis for a hearing concerning this action.

DATES: The order is applicable September 28, 2018.

ADDRESSES: Any application for termination of debarment by Fleming 
under section 306(d) of the FD&C Act (application) may be submitted as 
follows:

Electronic Submissions

     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. An application 
submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because 
your application will be made public, you are solely responsible for 
ensuring that your application does not include any confidential 
information that you or a third party may not wish to be posted, such 
as medical information, your or anyone else's Social Security number, 
or confidential business information, such as a manufacturing process. 
Please note that if you include your name, contact information, or 
other information that identifies you in the body of your application, 
that information will be posted on https://www.regulations.gov.
     If you want to submit an application with confidential 
information that you do not wish to be made available to the public, 
submit the application as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ''Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For a written/paper application submitted to the Dockets 
Management Staff, FDA will post your application, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: Your application must include the Docket No. FDA-
2013-N-

[[Page 49096]]

0333. An application will be placed in the docket and, unless submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit an application with 
confidential information that you do not wish to be made publicly 
available, submit your application only as a written/paper submission. 
You should submit two copies total. One copy will include the 
information you claim to be confidential with a heading or cover note 
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The 
Agency will review this copy, including the claimed confidential 
information, in its consideration of your application. The second copy, 
which will have the claimed confidential information redacted/blacked 
out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management 
Staff. If you do not wish your name and contact information to be made 
publicly available, you can provide this information on the cover sheet 
and not in the body of your application and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket, go to https://www.regulations.gov 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852 between 9 a.m. and 4 p.m., Monday through Friday. Publicly 
available submissions may be seen in the docket.

FOR FURTHER INFORMATION CONTACT: Rachael Vieder Linowes, Office of 
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 306(b)(2)(B)(ii)(I) of the FD&C Act (21 U.S.C. 
335a(b)(2)(B)(ii)(I)) permits FDA to debar an individual if it finds 
that the individual: (1) Has been convicted of a felony that involves 
bribery, payment of illegal gratuities, fraud, perjury, false 
statement, racketeering, blackmail, extortion, falsification or 
destruction of records, or interference with, obstruction of an 
investigation into, or prosecution of, any criminal offense and (2) 
based on the conviction and other information, the individual has 
demonstrated a pattern of conduct sufficient to find that there is 
reason to believe that the person may violate requirements under the 
FD&C Act relating to drug products.
    On April 24, 2009, Fleming, the president of, and sole physician 
at, Fleming Heart and Health Institute, P.C. (FHHI), pled guilty to one 
felony count of healthcare fraud, in violation of 18 U.S.C. 1347 and 2, 
and one felony count of mail fraud, in violation of 18 U.S.C. 1341 and 
2. On August 20, 2009, the U.S. District Court for the District of 
Nebraska entered a judgment of conviction against Fleming on these 
counts and sentenced Fleming to 5 years of probation.
    Fleming's convictions stemmed from two separate actions. Fleming, 
through his practice at FHHI, performed various imaging studies and 
submitted reimbursement claims to Medicare and Medicaid. Fleming pled 
guilty to one count of felony healthcare fraud in violation of 18 
U.S.C. 1347 and 2 for conduct related to the submission of a 
reimbursement claim. Fleming admitted to knowingly executing and 
attempting to execute a scheme to defraud Medicare and Medicaid 
healthcare benefit programs in connection with the delivery of and 
payment for healthcare benefits, items, and services, namely by 
submitting payment claims for tomographic myocardial perfusion imaging 
studies that he did not actually perform. Fleming also pled guilty to 
one count of felony mail fraud in violation of 18 U.S.C. 1341 and 2 for 
conduct relating to money paid him to conduct a clinical study of a soy 
chip food product for the purpose of evaluating health benefits. As 
Fleming admitted during his guilty plea, he received approximately 
$35,000 for conducting a clinical trial, but he fabricated data for 
certain subjects.
    By letter dated November 18, 2013, FDA's Office of Regulatory 
Affairs (ORA) notified Fleming of its proposal to debar him for 10 
years from providing services in any capacity to a person having an 
approved or pending drug product application. The proposal explained 
that the proposed debarment period was based on both felony fraud 
convictions. ORA stated that these convictions establish Fleming's 
disregard for his professional obligations and the law and provide 
reason to believe that, if he were to provide services to a person that 
has an approved or pending drug application, he may violate 
requirements under the FD&C Act relating to drug products. Therefore, 
ORA found that Fleming was subject to debarment under section 
306(b)(2)(B)(ii)(I) of the FD&C Act.
    The proposal noted that the maximum debarment period for each 
offense is 5 years and that FDA may determine whether debarment periods 
for multiple offenses should run concurrently or consecutively. The 
proposal outlined findings concerning the four relevant factors that 
ORA 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 any offense, (2) the nature and extent of 
management participation in any 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 
FDA's jurisdiction. ORA found that the first three were unfavorable 
factors and that the last was a favorable factor for Fleming. The 
notice concluded that ``the unfavorable factors cumulatively far 
outweigh the sole favorable factor.'' Accordingly, FDA determines that 
debarment is appropriate, and that the 5-year period of debarment for 
each of the two offenses should be served consecutively, resulting in a 
total debarment period of 10 years.
    Fleming timely responded to the proposal to debar and requested a 
hearing. Fleming's response included multiple documents in which he 
raises variations of two central arguments, namely that: (1) His guilty 
plea ``does not state a crime'' and (2) he is ``actually innocent.'' 
Fleming contends that his guilty plea was a ``holographic plea'' to 
protect his children.
    Under the authority delegated to him by the Commissioner of Food 
and Drugs, the Director of the Office of Scientific Integrity (OSI) has 
considered Fleming's request 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)).
    OSI has considered Fleming's arguments and concludes that they are 
unpersuasive and fail to raise a genuine and substantial issue of fact 
requiring a hearing.

[[Page 49097]]

II. Arguments

    Fleming submitted multiple documents in support of his arguments 
that his guilty plea ``does not state a crime'' and that he is 
``actually innocent.'' However, section 306(l) of the FD&C Act defines 
conviction as when a Federal or State court's judgment of conviction or 
when a Federal or State court's acceptance of a guilty plea. In 
Fleming's ``Petition to Enter a Plea of Guilty,'' he stated that he 
understood the charges against him and that he was voluntarily entering 
his guilty plea. The court entered a judgment of conviction after 
accepting Fleming's guilty plea. Federal court is the proper venue for 
any challenge to Fleming's guilty plea based on a claim of actual 
innocence, not this remedial proceeding. OSI carefully reviewed 
Fleming's submission in its entirety, and Fleming does not dispute that 
the court entered a judgment of conviction or that the court accepted 
his guilty plea; therefore, Fleming's arguments regarding his actual 
innocence fail to raise a genuine and substantial issue of fact 
warranting a hearing.
    Under section 306(b)(2)(B)(ii)(I) of the FD&C Act, FDA has the 
authority to debar an individual convicted of certain Federal felonies, 
involving, among other things, fraud, if FDA finds that the individual 
has demonstrated a pattern of conduct giving reason to believe that he 
may violate requirements under the FD&C Act relating to drug products. 
The relevant factual issues are whether Fleming was, in fact, convicted 
of a felony involving fraud and whether there is reason to believe that 
he may violate requirements under the FD&C Act relating to drug 
products. Fleming does not dispute that he pled guilty to felony 
healthcare fraud and felony mail fraud or that, based on these 
convictions, there is reason to believe that he may violate 
requirements under the FD&C Act relating to drug products. Therefore, 
Fleming has failed to raise a genuine and substantial issue of fact 
warranting a hearing regarding whether he is subject to debarment.
    Fleming's response included one argument that may be construed to 
be a challenge to ORA's proposed findings on the nature and seriousness 
of his offense. Fleming appears to claim that the imaging studies he 
performed on his patients were safer than the imaging studies he billed 
to Medicare and Medicaid. In the proposal to debar, in evaluating the 
nature and seriousness of the offenses, ORA noted that Fleming was 
convicted of two felonies, healthcare fraud and mail fraud. ORA 
considered that he billed Medicare and Medicaid for procedures other 
than those that he had performed, that he falsified clinical trial 
data, and that his actions ``have the potential for causing significant 
loss of public confidence in the healthcare system.'' Fleming's actions 
took place over a period of several months and demonstrated multiple 
instances of fraud. While Fleming contends that he performed safer 
imaging studies than those billed, FDA must weigh this claim against 
the serious nature of the fraud he committed. Construing Fleming's 
argument in a light most favorable to him, whether he performed safer 
imaging studies does not sufficiently counter the very serious nature 
of fraudulent conduct and is not enough to establish that a shorter 
debarment period would be appropriate.
    Based on the factual findings in the proposal to debar and on the 
record, OSI finds that a 5-year debarment period for each felony 
offense is appropriate. The nature and seriousness of Fleming's 
offense, Fleming's managerial participation, and his lack of voluntary 
steps to mitigate the impact on the public weigh in favor of debarment. 
Although Fleming does not appear to have prior criminal convictions 
involving matters within FDA's jurisdiction, a debarment period of 5 
years for each felony conviction is appropriate. As noted in the 
proposal to debar, the conduct underlying the offenses involved 
submitting claims for payment for procedures other than the procedures 
Fleming performed and falsifying clinical trial data, and ``[t]he 
conduct that form[ed] the basis of [his] conviction occurred in the 
course of [his] profession and showed disregard for the obligations of 
[his] profession and the law.'' Based on the pattern of fraudulent 
conduct, FDA has reason to believe that Fleming may violate the 
requirements under the FD&C Act relating to drug products. Furthermore, 
given that Fleming has offered no arguments challenging the proposed 
determination regarding the extent to which his debarment periods 
should run concurrently or consecutively, OSI further determines that 
the 5-year debarment period for each felony conviction should run 
consecutively, resulting in a total debarment of 10 years.

III. Findings and Order

    Therefore, the Director of OSI, under section 306(b)(2)(B)(i)(I) of 
the FD&C Act and authority delegated to him by the Commissioner of Food 
and Drugs, finds that: (1) Fleming has been convicted of a felony which 
involves bribery, payment of illegal gratuities, fraud, perjury, false 
statement, racketeering, blackmail, extortion, falsification or 
destruction of records, or interference with, obstruction of an 
investigation into, or prosecution of, any criminal offense and (2) 
based on the conviction and other information, Fleming has demonstrated 
a pattern of conduct giving reason to believe that he may violate 
requirements under the FD&C Act relating to drug products. FDA 
considered the applicable factors listed in section 306(c)(3) of the 
FD&C Act and determined that a debarment of 10 years is appropriate.
    As a result of the foregoing findings, Fleming is debarred for 10 
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 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 Fleming, in any 
capacity during his period of 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 Fleming, 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 (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 Fleming during his period of debarment (section 
306(c)(1)(B) of the FD&C Act).

    Dated: September 25, 2018.
George M. Warren,
Director, Office of Scientific Integrity.
[FR Doc. 2018-21210 Filed 9-27-18; 8:45 am]
 BILLING CODE 4164-01-P