[Federal Register Volume 88, Number 16 (Wednesday, January 25, 2023)]
[Notices]
[Pages 4826-4828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01426]


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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.

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[[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

     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: 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 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 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.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, 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, 
[email protected], 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