[Federal Register Volume 86, Number 70 (Wednesday, April 14, 2021)]
[Notices]
[Pages 19625-19626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07638]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1565]


Mark Reinhard: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently 
debarring Mark Reinhard 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 Mr. Reinhard was convicted of a 
felony under Federal law for conduct that relates to the regulation of 
a drug product under the FD&C Act. Mr. Reinhard was given notice of the 
proposed permanent debarment and an opportunity to request a hearing to 
show why he should not be debarred within the timeframe prescribed by 
regulation. Mr. Reinhard has not responded to the notice. Mr. 
Reinhard's failure to respond and request a hearing within the 
prescribed timeframe constitutes a waiver of his right to a hearing 
concerning this action.

DATES: This order is applicable April 14, 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 (ELEM-4029), Division 
of Enforcement, 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(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 March 28, 2019, Mr. Reinhard 
entered a plea of guilty to one count of engaging in unlicensed 
wholesale distribution of prescription drugs in violation of sections 
301(t), 303(b)(1)(D), and 503(e)(1)(A) of the FD&C Act (21 U.S.C. 
331(t), 333(b)(1)(D), and 353(e)(1)(A)) and (18 U.S.C. 2), a felony 
offense under Federal law. On January 16, 2020, judgment of conviction 
was entered against Mr. Reinhard for this felony offense in the U.S. 
District Court for the Western District of Kentucky, Louisville 
Division.
    The factual basis for this conviction is as follows: Mr. Reinhard 
was a pharmacist residing in the State of West Virginia and was 
employed by Meds 2 Go Express Pharmacy, Inc. (Meds 2 Go Express). From 
November 2010 through at least August 2012, he aided and abetted 
others, through Meds 2 Go Express, by engaging in unlicensed wholesale 
distribution of Tramadol from West Virginia to Alabama through 
Kentucky. Specifically, Mr. Reinhard aided and abetted individuals who 
combined, conspired, confederated, and agreed to engage in a scheme to 
sell, distribute, and dispense prescription drugs over the internet and 
to deliver those prescription drugs to customers, without the issuance 
of valid prescriptions. Under this scheme, customers would order 
prescription drugs from websites without ever seeing or speaking to a 
physician or medical practitioner. On the website, customers chose 
which prescription drugs they wished to order, and completed an online 
medical questionnaire with prepopulated answers that did not disqualify 
the customers from receiving the prescription drugs that they ordered. 
The website operator would then send the completed online medical 
questionnaires to doctors or individuals posing as doctors, who issued 
the prescriptions requested by the customers without first conducting 
an in-person medical examination, speaking with the customers, 
reviewing the customers' medical records, or otherwise verifying any of 
the information provided by the customer. These invalid prescriptions 
were issued outside of the usual course of professional practice and 
were not for a legitimate medical purpose. The website operators would 
then send the issued prescription by electronic means to pharmacies, 
including Meds 2 Go Express, to be filled. After filling a 
prescription, Meds 2 Go Express and other pharmacies would send the 
prescription drugs to the customers, who often were not in the same 
State as the pharmacy, via the U.S. Postal Service or other delivery 
methods. It was found that Mr. Reinhard distributed

[[Page 19626]]

the prescription drug Tramadol from West Virginia to a wholesale 
fulfillment pharmacy located in Alabama through Kentucky in violation 
of Federal law. Tramadol, as contained in the drug product ULTRAM and 
generic formulations, is a prescription painkiller that may induce 
psychic and physical dependence.
    Based on this conviction, FDA sent Mr. Reinhard by certified mail 
on October 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 Mr. Reinhard was 
convicted, as set forth in section 306(l)(1) of the FD&C Act, of a 
felony under Federal law for conduct relating to the regulation of a 
drug product under the FD&C Act. The proposal also offered Mr. Reinhard 
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 file a timely request for a hearing would 
constitute an election not to use the opportunity for a hearing and a 
waiver of any contentions concerning this action. Mr. Reinhard received 
the proposal on October 10, 2020. He 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 Mr. 
Reinhard has been convicted of a felony under Federal law for conduct 
relating to the regulation of a drug product under the FD&C Act.
    As a result of the foregoing finding, Mr. Reinhard 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 (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 in any capacity the services of Mr. Reinhard 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 Mr. Reinhard 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 
application from Mr. Reinhard during his period of debarment, other 
than in connection with an audit under section 306 of the FD&C Act 
(section 306(c)(1)(B) of the FD&C Act). Note that, for purposes of 
sections 306 and 307 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, or 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 Mr. Reinhard for special termination of 
debarment under section 306(d)(4) of the FD&C Act should be identified 
with Docket No. FDA-2020-N-1565 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 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: April 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07638 Filed 4-13-21; 8:45 am]
BILLING CODE 4164-01-P