Notice2023-01426
Mark Moffett; Denial of Hearing; Final Debarment Order
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
January 25, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Mark Moffett and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Mr. Moffett 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 Mr. Moffett was convicted of multiple felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Mr. Moffett was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Moffett submitted a request for hearing but failed to file with the Agency information and analysis sufficient to create a basis for a hearing.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 16 (Wednesday, January 25, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 16 (Wednesday, January 25, 2023)]
[Notices]
[Pages 4826-4828]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-01426]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0198]
Mark Moffett; Denial of Hearing; Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 4827]]
SUMMARY: The Food and Drug Administration (FDA or Agency) is denying a
request for a hearing submitted by Mark Moffett and is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently
debarring Mr. Moffett 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 Mr. Moffett was convicted of
multiple felonies under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act. Mr. Moffett was given
notice of the proposed debarment and an opportunity to request a
hearing within the timeframe prescribed by regulation. Mr. Moffett
submitted a request for hearing but failed to file with the Agency
information and analysis sufficient to create a basis for a hearing.
DATES: The order is applicable January 25, 2023.
ADDRESSES: Any application for termination of debarment by Mr. Moffett
under section 306(d) of the FD&C Act (21 U.S.C. 335a(d)) (application)
may be submitted as follows:
Electronic Submissions
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. An application
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 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<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 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: All applications must include the Docket No. FDA-
2022-N-0198. An application will be placed in the docket and, unless
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 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 <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 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: <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, between 9 a.m. and 4 p.m., Monday through Friday, 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,
<a href="/cdn-cgi/l/email-protection#f5a794969d949099dbb99c9b9a829086b5939194db9d9d86db929a83"><span class="__cf_email__" data-cfemail="de8cbfbdb6bfbbb2f092b7b0b1a9bbad9eb8babff0b6b6adf0b9b1a8">[email protected]</span></a>, 240-402-5931.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act mandates permanent debarment
if FDA finds that the individual has been convicted of a felony under
Federal law for conduct relating to the regulation of any drug product
under the FD&C Act.
On January 18, 2022, the U.S. District Court for the District of
Massachusetts entered a judgment against Mr. Moffett, after a jury
verdict, for nine counts of wire fraud in violation of 18 U.S.C. 1343
and five counts of aggravated identify theft in violation of 18 U.S.C.
1028A(a)(1). The court sentenced Mr. Moffett to 54 months in prison,
$1,500 restitution payment, and upon his release from prison, a 36-
month supervised release. The bases for his convictions stem from his
employment with Aegerion Pharmaceuticals, Inc. (Aegerion), a
pharmaceutical company located in Massachusetts, which held an approved
drug application for the drug JUXTAPID (NDA 203858).
According to FDA's Office of Regulatory Affairs' (ORA) proposal to
debar, discussed in more detail below, JUXTAPID was subject to risk
evaluation and mitigation strategies (REMS) requirements due to
JUXTAPID's risk of liver toxicity. JUXTAPID prescribers had to enroll
in the JUXTAPID REMS program and attest that the patients to which they
prescribed JUXTAPID had a diagnosis consistent with homozygous familial
hypercholesterolemia (HoFH). JUXTAPID was only distributed by certain
pharmacies and prior to dispensing, the pharmacy had to verify that the
prescriber was certified in the JUXTAPID REMS program. Additionally,
insurance companies would not pay for JUXTAPID if the patient did not
have a HoFH diagnosis, so to facilitate insurance claims processing for
patients, Aergerion established the patient access program (PAP), and
the PAP personnel would call health insurance companies to obtain
insurance coverage determinations for patients who had been prescribed
JUXTAPID.
According to the proposal to debar, Mr. Moffett was a sales
representative for Aegerion. Aegerion paid its sales representatives a
base salary, plus bonuses for new prescriptions and bonuses for
patients remaining on JUXTAPID over time. ORA found that Mr. Moffett
schemed to enrich himself through the bonus program, and as part
[[Page 4828]]
of that scheme, from on or about January 2014 through at least October
2015, convinced doctors to prescribe JUXTAPID for statin intolerant
patients who had not been diagnosed with HoFH. According to the
proposal to debar, Mr. Moffett, among other actions:
1. Directed and caused JUXTAPID REMS forms, statements of medical
necessity, and insurance forms to be submitted to insurance plans for
JUXTAPID coverage by falsely representing that the prescriptions were
for patients with HoFH;
2. Obtained fraudulent REMS forms from prescribers or obtained
prescriptions from providers who had not treated relevant patients; and
3. Sent falsified prior authorizations or caused the falsified
prior authorizations forms to be sent to PAP personnel, causing them to
communicate the false information to insurance companies.
ORA's proposal to debar stated that Mr. Moffett received tens of
thousands of dollars in bonuses for making purported sales of JUXTAPID.
By letter dated July 5, 2022, ORA notified Mr. Moffett of a
proposal to permanently debar him from providing services in any
capacity to a person having an approved or pending drug product
application, based on the multiple convictions and underlying conduct
outlined above. In addition to outlining the above information, ORA
found that the wire fraud and aggravated identity theft felonies were
for conduct relating to the regulation of drug products. ORA found that
Mr. Moffett's actions undermine the process for the regulation of drugs
because Mr. Moffett schemed to deceive health insurance companies into
covering JUXTAPID for ineligible patients. Additionally, ORA found that
Mr. Moffett's actions circumvented the REMS program, which subverted
safety protocols put into place as part of JUXTAPID's approval.
Therefore, ORA found that permanent debarment was appropriate.
By letter, dated August 4, 2022, Mr. Moffett submitted a document
titled ``request for a hearing.'' This letter did not contain an actual
request for a hearing, but the Director of the Office of Scientific
Integrity (OSI) construed it as one. In addition, OSI granted Mr.
Moffett an extension to submit any information or factual analyses in
support of his request for a hearing until October 31, 2022. Mr.
Moffett submitted another letter on October 11, 2022.
Under the authority delegated to her by the Commissioner of Food
and Drugs, the Chief Scientist has considered Mr. Moffett'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)).
Neither of Mr. Moffett's letters provides any information or
factual analysis in rebutting the proposed findings in ORA's proposal
to debar him. Instead, both letters state that he is currently
appealing the convictions on which the proposed debarment is based.
Specifically, in Mr. Moffett's October 11, 2022, letter, he requests a
delay in the debarment proceeding until the conclusion of his appeal,
and states that, ``if a hearing is scheduled before [he] receive[s] the
results of [his] appellate appeal,'' he would like to know when the
hearing will take place so that he may participate.
As previously explained in OSI's letter to Mr. Moffett granting him
an extension, under section 306(l) of the FD&C Act, ``a person is
considered to have been convicted of a criminal offense . . . (A) when
a judgment of conviction has been entered against the person by a
Federal or State court, regardless of whether there is an appeal
pending.'' A pending appeal is therefore not a ground for postponing
either ruling on a hearing request or conducting a hearing on a
proposed debarment. However, if Mr. Moffett's appeal ultimately results
in the convictions being overturned, he may seek termination of his
debarment (see section 306(d)(B)(ii) of the FD&C Act).
Given that Mr. Moffett did not submit any information or factual
analyses addressing the findings in ORA's proposal to debar him, Mr.
Moffett has not raised a genuine and substantial issue of fact
regarding whether he was convicted of a felony under Federal law for
conduct relating to the regulation of a drug product under the FD&C
Act. Therefore, OSI denies Mr. Moffett's request for a hearing.
II. Findings and Order
The Chief Scientist, under section 306(a)(2) of the FD&C Act and
under the authority delegated to her, finds that Mr. Mark Moffett has
been convicted of felonies under Federal law for conduct relating to
the regulation of a drug product under the FD&C Act.
As a result of the foregoing findings, Mr. Moffett is permanently
debarred 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)(ii) and 21 U.S.C. 321(dd)). Any
person with an approved or pending drug product application who
knowingly uses the services of Mr. Moffett, 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 Mr. Moffett,
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 Mr. Moffett during
his period of debarment.
Dated: January 19, 2023.
Namandje N. Bumpus,
Chief Scientist.
[FR Doc. 2023-01426 Filed 1-24-23; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on January 25, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.