2020-16046. Euton M. Laing: Final Debarment Order

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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, [e-mail], 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 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.