Notice2023-04003
Richard M. Fleming; Denial of Hearing on Application for Termination of Debarment
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 28, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 39 (Tuesday, February 28, 2023)</title>
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[Federal Register Volume 88, Number 39 (Tuesday, February 28, 2023)]
[Notices]
[Pages 12686-12688]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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]]
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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
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</html>Indexed from Federal Register on February 28, 2023.
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