[Federal Register Volume 86, Number 57 (Friday, March 26, 2021)]
[Notices]
[Pages 16222-16223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, 240-402-7500, 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, 240-402-8743, or at 
[email protected].

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

[[Page 16223]]

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, 240-402-7500.

    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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