[Federal Register Volume 88, Number 39 (Tuesday, February 28, 2023)]
[Notices]
[Pages 12686-12688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04003]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Richard M. Fleming; Denial of Hearing on Application for 
Termination of Debarment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
denying Dr. Richard M. Fleming's (Dr. Fleming's) request for a hearing 
and denying his application for termination of debarment under the 
Federal Food, Drug, and Cosmetic Act (FD&C Act). Dr. Fleming has failed 
to file information and analyses sufficient to create a basis for a 
hearing concerning this action.

DATES: This order is applicable February 28, 2023.

ADDRESSES: You may be submit comments at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:

[[Page 12687]]

     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
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 comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

     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 written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0333 for ``Richard M. Fleming; Denial of Hearing on 
Application for Termination of Debarment.'' Received comments will be 
placed in the docket and, except for those 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, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments 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 comments. 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 comments 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.govinfo.gov/content/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, 240-402-7500. 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

    On April 24, 2009, Dr. 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 Dr. 
Fleming on these counts and sentenced Dr. Fleming to 5 years of 
probation. In pleading guilty to those offenses, Dr. Fleming admitted 
that his convictions stemmed from two separate actions. Dr. Fleming, 
through his practice at FHHI, performed various imaging studies and 
submitted reimbursement claims to Medicare and Medicaid. Dr. Fleming's 
felony healthcare fraud related to the submission of a reimbursement 
claim. Dr. 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. Dr. Fleming's felony mail fraud violation related to 
money paid to him to conduct a clinical study of a soy chip food 
product for the purpose of evaluating health benefits. As Dr. 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, pursuant to section 
306(b)(2)(B)(ii)(I) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(ii)(I)), 
FDA's Office of Regulatory Affairs (ORA) notified Dr. Fleming of its 
proposal to debar him for 10 years based on those convictions. On 
September 28, 2018, FDA debarred Dr. Fleming for 10 years from 
providing services in any capacity to a person with an approved or 
pending drug product application. Following that debarment, Dr. Fleming 
made various submissions from September 2018 to October 2018, which FDA 
construed as a petition for reconsideration and denied on November 28, 
2018.
    On March 15, 2022, Dr. Fleming applied for termination of debarment 
pursuant to section 306(d)(1) of the FD&C Act. Absent a conviction 
reversal, FDA may grant an application to terminate debarment pursuant 
to section 306(b)(2)(B) only when ``termination serves the interests of 
justice and adequately protects the integrity of the drug approval 
process'' (see section 306(d)(3)(B)).
    By letter dated July 12, 2022, ORA offered Dr. Fleming an 
opportunity for a hearing under 21 CFR part 12 on a proposal to deny 
his application for termination of debarment. In the letter, ORA stated 
that, considering all the favorable and unfavorable information in 
light of the remedial public health purposes underlying debarment, 
terminating Dr. Fleming's debarment would not best serve the interests 
of justice and would not adequately protect the integrity of the drug 
approval process.
    Under the authority delegated by the Commissioner of Food and 
Drugs, the Chief Scientist has considered Dr. 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 Sec.  12.24(b) (21 CFR 
12.24(b))).

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    The Chief Scientist has considered Dr. Fleming's arguments, as well 
as the proposal to deny Dr. Fleming's application for termination of 
debarment and concludes that there is no genuine and substantial issue 
of fact requiring a hearing. Further, the Chief Scientist finds that 
Dr. Fleming's application does not satisfy the grounds for terminating 
debarment.

II. Arguments

    In his response to ORA's proposal to deny his request for 
termination, Dr. Fleming concedes that the convictions underlying his 
debarment pursuant to section 306(b)(2)(B)(ii)(I) of the FD&C Act have 
not been reversed. FDA could therefore only terminate his debarment 
under section 306(d)(3)(B) if the Agency determined that such 
termination would serve the interests of justice and adequately protect 
the integrity of the drug approval process. In the application to 
terminate his debarment, Dr. Fleming presented three reasons for 
terminating his debarment: (1) that he was effectively debarred in the 
period between when he was convicted of the two felony offenses on 
which his debarment was based and when FDA finalized his debarment; (2) 
that he has taken training courses related to billing and ethics; and 
(3) that he has taken steps to prevent future mistakes in billing and 
collecting data.
    In proposing to deny Dr. Fleming's application to terminate his 
debarment, ORA weighed the seriousness and nature of the offenses that 
led to his debarment, including his culpability, against his statements 
regarding other mitigating factors. After accounting for his assertions 
that he had effectively been debarred since his original convictions, 
ORA found that Dr. Fleming had not established that terminating his 
debarment would serve the interests of justice or adequately protect 
the integrity of the drug approval process. In his request for a 
hearing on ORA's proposal, Dr. Fleming repeats some of the arguments 
from his application for termination of debarment and provides some 
additional context related to his own views on drug regulation, the 
criminal justice system, and other ethical considerations. He further 
clarifies some of the corrective actions he has implemented with 
respect to patient billing.
    As a preliminary matter, the Chief Scientist notes Dr. Fleming's 
request in his application for termination of debarment that FDA 
consider the time starting from when he was convicted in 2009 as ``time 
served.'' Dr. Fleming contended that, because he was convicted in 2009, 
``the effective period of debarment has been 12+ years.'' While Dr. 
Fleming does not renew this argument in his request for a hearing on 
ORA's proposal, the timing of when he was convicted, when ORA proposed 
his debarment, and when FDA finalized his debarment is not in dispute. 
Notwithstanding his arguments to the contrary, FDA did not debar Dr. 
Fleming until the Agency issued the final order debarring him in 
September 2018. Neither his convictions nor ORA's proposal to debar him 
started his debarment period pursuant to the Agency's authority under 
section 306(b)(2)(B)(ii)(I) of the FD&C Act. He thus cannot now argue 
that his ultimate debarment in September 2018 had any effect whatsoever 
on him before that time. The Chief Scientist therefore agrees with ORA 
that terminating his debarment on that basis would not serve the 
interests of justice or adequately protect the integrity of the drug 
approval process.
    The Chief Scientist further agrees with ORA that Dr. Fleming has 
not shown that terminating his debarment would serve the interests of 
justice or adequately protect the drug approval process--even in light 
of the additional assertions and arguments proffered in support of his 
hearing request on ORA's proposal. Both offenses underlying his 
debarment are felony fraud convictions related to the regulation of 
drugs. As noted in ORA's proposal to deny Dr. Fleming's application for 
termination, the pattern of fraudulent conduct on which his convictions 
were based calls into question his ability to comply with the FD&C Act 
and indicates that he poses a threat to the drug approval process if he 
were allowed to participate in it. In light of the conduct underlying 
the convictions on which Dr. Fleming's debarment was based, his 
assertions that he has taken some courses and adopted corrective 
measures relative to billing patients and collecting data do not come 
close to showing that terminating his debarment would serve the 
interests of justice and adequately protect the drug approval process 
in the sense contemplated by section 306(d)(3)(B)(ii). Dr. Fleming has 
thus presented no material factual dispute for a hearing on ORA's 
proposal to deny the application to terminate his debarment.

III. Conclusion

    Therefore, the Chief Scientist, under authority delegated to her, 
denies Dr. Fleming's application for termination of debarment under 
section 306(d) of the FD&C Act. A hearing on this request is not 
necessary because there are no genuine and substantial issues of fact 
(see Sec.  12.24(b)).
    Any person with an approved or pending drug product application who 
knowingly uses the services of Dr. 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 Dr. Fleming 
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 Dr. Fleming during his period of debarment 
(section 306(c)(1)(B) of the FD&C Act).

    Dated: February 22, 2023.
Namandj[eacute] N. Bumpus,
Chief Scientist.
[FR Doc. 2023-04003 Filed 2-27-23; 8:45 am]
 BILLING CODE 4164-01-P