[Federal Register Volume 86, Number 57 (Friday, March 26, 2021)]
[Notices]
[Pages 16222-16223]
[FR Doc No: 2021-06219]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2002]

Thomas J. Whalen: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring
Thomas J. Whalen for a period of 10 years from importing or offering
for import any drug into the United States. FDA bases this order on a
finding that Mr. Whalen was convicted of multiple offenses; two of
these are relevant to this debarment: One count of importation contrary
of law-aiding and abetting and one count of healthcare fraud-aiding and
abetting. The factual basis supporting Mr. Whalen's conviction is
conduct relating to the importation into the United States of a drug or
controlled substance. Mr. Whalen was given notice of the proposed
debarment and was given an opportunity to request a hearing to show why
he should not be debarred. As of January 13, 2021 (30 days after
receipt of the notice), Mr. Whalen had not responded. Mr. Whalen's
failure to respond and request a hearing constitutes a waiver of his
right to a hearing concerning this matter.

DATES: This order is applicable March 26, 2021.

ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, or at
https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4029), Office of Strategic Planning and Operational
Policy, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857,<PHONE_NUMBER>, or at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(1)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D))
permits debarment of an individual from importing or offering for
import any drug into the United States if FDA finds, as required by
section 306(b)(3)(C) of the FD&C Act, that the individual has been
convicted of a felony for conduct relating to the importation into the
United States of any drug or controlled substance. On September 15,
2020, Mr. Whalen was convicted, as defined in section 306(l)(1) of the
FD&C Act, in the U.S. District Court for the Eastern District of
Pennsylvania, when the court entered judgment against him for multiple
offenses, two of which are relevant to this debarment: One count of
importation contrary to law-aiding and abetting in violation of 18
U.S.C. 545 and 2, and one count of healthcare fraud-aiding and abetting
in violation of 18 U.S.C. 1347 and 2.
    FDA's finding that debarment is appropriate is based on the felony
convictions referenced herein. The factual basis for this conviction is
as follows: As contained in the information in Mr. Whalen's case, filed
on October 25, 2019, to which he pleaded guilty, he was a doctor of
osteopathy in the Commonwealth of Pennsylvania and the State of
Delaware. From about January 2014 to about March 2018, Mr. Whalen
engaged in a scheme to defraud Medicare, the U.S. Office of Personnel
Management (OPM), and the Independence Blue Cross insurance company
(IBC). Specifically, he purchased, imported into the United States, and
distributed misbranded and non-FDA-approved injectable versions of
REMICADE (infliximab), SYNVISC/SYNVISC ONE (hyaluronan), ORENCIA
(abatacept), PROLIA/XGEVA (denosumab), and BONIVA (ibandronate sodium).
He then injected his patients with these non-FDA-approved versions of
these medications. Mr. Whalen billed Medicare, OPM, and IBC for the
provision of the FDA-approved versions of these products.
    As a result of this conviction, FDA sent Mr. Whalen, by United
Parcel Service, on December 11, 2020, a notice proposing to debar him
for a 10-year period from importing or offering for import any drug
into the United States. The proposal was based on a finding under
section 306(b)(3)(C) of the FD&C Act that Mr. Whalen's felony
conviction for two felony counts under Federal law related to this
debarment, specifically for one count of importation contrary to law-
aiding and abetting and one count of healthcare fraud-aiding and
abetting, was for conduct relating to the importation into the United
States of any drug or controlled substance, because he illegally
imported unapproved and misbranded drugs into the United States and
then distributed those misbranded and unapproved drugs to consumers in
the United States.
    In proposing a debarment period, FDA weighed the considerations set
forth in section 306(c)(3) of the FD&C Act that it considered
applicable to Mr. Whalen's offenses and concluded that each felony
offense warranted the imposition of a 5-year period of debarment, for a
total debarment period of 10 years. The proposal informed Mr. Whalen of
the proposed debarment and offered him an opportunity to request a
hearing, providing him 30 days from the date of receipt of the letter
in which to file the request, and advised him that failure to request a
hearing constituted a waiver of the opportunity for a hearing and of
any contentions concerning this action. Mr. Whalen received the
proposal and notice of opportunity for

a hearing on December 14, 2020. Mr. Whalen failed to request a hearing
within the timeframe prescribed by regulation and has, therefore,
waived his opportunity for a hearing and waived any contentions
concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr.
Whalen has been convicted of felonies under Federal law for conduct
relating to the importation into the United States of any drug or
controlled substance. FDA finds that the offenses should be accorded a
debarment period of 10 years as provided by section 306(c)(2)(A)(iii)
of the FD&C Act.
    As a result of the foregoing finding, Mr. Whalen is debarred for a
period of 10 years from importing or offering for import any drug into
the United States, effective (see DATES). Pursuant to section 301(cc)
of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for
import into the United States of any drug or controlled substance by,
with the assistance of, or at the direction of Mr. Whalen is a
prohibited act.
    Any application by Mr. Whalen for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2020-N-2002 and sent to the Dockets Management Staff (see
ADDRESSES). The public availability of information in these submissions
is governed by 21 CFR 10.20(j).
    Publicly available submissions will be placed in the docket and
will be viewable at https://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday,<PHONE_NUMBER>.

    Dated: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06219 Filed 3-25-21; 8:45 am]
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