[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