[Federal Register Volume 85, Number 143 (Friday, July 24, 2020)]
[Notices]
[Pages 44898-44899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16046]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5439]
Euton M. Laing: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
permanently debarring Euton M. Laing 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 Dr. Laing was
convicted of a felony under Federal law for conduct that relates to the
regulation of a drug product under the FD&C Act. Dr. Laing was given
notice of the proposed permanent debarment and an opportunity to
request a hearing to show why he should not be debarred. As of March
11, 2020 (30 days after receipt of the notice), Dr. Laing had not
responded. Dr. Laing's failure to respond and request a hearing
constitutes a waiver of his right to a hearing concerning this action.
DATES: This order is applicable July 24, 2020.
ADDRESSES: Submit applications for special termination of debarment to
the Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville,
MD 20857, [email protected], or at 240-402-8743.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
requires debarment of an individual from providing services in any
capacity to a person that has an approved or pending drug product
application 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 August 22, 2019, Dr. Laing was
convicted as defined in section 306(l)(1) of the FD&C Act when judgment
was entered against him in the U.S. District Court for the Western
District of Kentucky, after his plea of guilty, to one count of
conspiracy to distribute, with intent to defraud and mislead,
misbranded drugs dispensed by Meds 2 Go, Inc in violation of sections
301(a) and 503(b)(1) of the FD&C Act (21 U.S.C. 331(a) and 353(b)(1))
and 18 U.S.C. 2 and 371, and a second count of conspiracy to
distribute, with intent to defraud and mislead, misbranded drugs
dispensed by Aracoma Drug Co. in violation of sections 301(a) and
503(b)(1) of the FD&C Act and 18 U.S.C. 2 and 371.
The factual basis for this conviction is as follows: As contained
in the Plea Agreement filed in his case on July 17, 2018, from 2010
through at least 2011, Dr. Laing conspired with others to provide
prescription drugs to Rx Limited internet customers that were
misbranded within the meaning of the FD&C Act, because the drugs were
prescribed without a valid prescription in violation of sections 301(a)
and 503(b)(1) of the FD&C Act. The prescriptions were not valid because
they were issued outside of the scope of professional practice.
Specifically, the prescriptions were issued based on limited medical
questionnaires and without face-to-face encounters. The misbranded
prescription drugs were then dispensed by Aracoma Drug Co. and Meds 2
Go, Inc. The misbranded prescription drugs were sent to customers in
various locations.
As a result of this conviction, FDA sent Dr. Laing by certified
mail on February 5, 2020, a notice proposing to permanently debar him
from providing services in any capacity to a person that
[[Page 44899]]
has an approved or pending drug product application. The proposal was
based on a finding, under section 306(a)(2)(B) of the FD&C Act, that
Dr. Laing was convicted of felonies under Federal law for conduct
relating to the regulation of a drug product under the FD&C Act. The
proposal also offered Dr. Laing 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 an election not to use the opportunity for a hearing and a
waiver of any contentions concerning this action. Dr. Laing received
the proposal on February 10, 2020. Dr. Laing did not request a hearing
within the timeframe prescribed by regulation and has, therefore,
waived his opportunity for a hearing and 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(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Euton M.
Laing has been convicted of a felony under Federal law for conduct
otherwise relating to the regulation of a drug product under the FD&C
Act.
As a result of the foregoing finding, Euton M. Laing, is
permanently debarred from providing services in any capacity to a
person with an approved or pending drug product application, effective
(see DATES) (see sections 306(a)(2)(B) and 306(c)(2)(A)(ii) of the FD&C
Act). Any person with an approved or pending drug product application
who knowingly employs or retains as a consultant or contractor, or
otherwise uses the services of Euton M. Laing, in any capacity during
his 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. Laing
provides services in any capacity to a person with an approved or
pending drug product application during his period of debarment, 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 from Dr. Laing during his period of debarment, other
than in connection with an audit under section 306 of the FD&C Act.
Note that, for purposes of section 306 of the FD&C Act, a ``drug
product'' is defined as a drug subject to regulation under section 505,
512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, 382) or under section
351 of the Public Health Service Act (42 U.S.C. 262) (section 201(dd)
of the FD&C Act (21 U.S.C. 321(dd))).
Any application by Dr. Laing for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2019-N-5439 and sent to the Dockets Management Staff
(see ADDRESSES). The public availability of information in these
submissions is governed by 21 CFR 10.20.
Publicly available submissions may be seen in the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: July 17, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16046 Filed 7-23-20; 8:45 am]
BILLING CODE 4164-01-P