[Federal Register Volume 86, Number 40 (Wednesday, March 3, 2021)]
[Notices]
[Pages 12482-12483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04375]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1638]


Lawrence B. Ryan: 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 Lawrence B. Ryan 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. Ryan 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. Ryan 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 October 
18, 2020 (30 days after receipt of the notice), Mr. Ryan had not 
responded. Mr. Ryan'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 March 3, 2021.

ADDRESSES: Submit applications for termination of debarment to the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers

[[Page 12483]]

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 June 18, 2020, Mr. Ryan 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 Eastern 
District of Virginia, Norfolk Division, after his plea of guilty to one 
count of conspiracy to defraud the United States in violation of 18 
U.S.C. 371.
    The factual basis for this conviction is as follows: As contained 
in the Statement of Facts in Mr. Ryan's case, filed on January 8, 2020, 
from October 2007, and continuing through September 2010, Mr. Ryan, a 
physician, authorized drug orders for RX Limited (also known as RX 
Partners), an internet pharmacy organization that facilitated the 
unlawful distribution of prescription drugs to consumers throughout the 
United States. RX Limited had a business model whereby it allowed 
consumers to fill out a brief medical questionnaire, select the type of 
drugs the consumer desired, the desired drug strength, and the desired 
drug quantity and pay by credit card. RX Limited then forwarded the 
order to a participating physician for ``approval.'' The drugs sold by 
RX Limited were dispensed without a valid prescription because there 
was no valid doctor-patient relationship established between the 
authorizing physicians and the customers. Customers had no face-to-face 
contact with the participating physician and were not subject to any 
mental or physical examinations.
    The physicians authorizing the orders for prescription drugs sold 
by RX Limited did not take patient histories or perform any diagnostic 
or laboratory testing, did not check the accuracy of the information 
customers provided (including their identities, ages, and qualifying 
medical conditions), and did not monitor, or provide any means to 
monitor, medication response. After the participating physician 
authorized the prescription, RX Limited sent the order to a fulfillment 
pharmacy, which fulfilled the order and mailed the drugs to the 
customer.
    As a participating physician, Mr. Ryan authorized more than 158,000 
drug orders for well over 10 individual RX Limited customers. 
Prescription drugs distributed pursuant to these orders included, 
FIORICET (and its generic equivalents), Carisoprodol (SOMA), Tramadol 
(ULTRAM), VIAGRA, CIALIS, and XENICAL. RX Limited paid Mr. Ryan $2.00 
per drug order he authorized. From October 2007 through September 2010, 
RX Limited paid Mr. Ryan at least $316,153 for the orders he 
authorized.
    As a result of this conviction, FDA sent Mr. Ryan by certified mail 
on September 11, 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. Ryan was convicted 
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. Ryan 
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. Mr. Ryan received the proposal on September 18, 
2020. Mr. Ryan 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. Ryan, 
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, Mr. Ryan, 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 the services of, Mr. Ryan, 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 Mr. Ryan 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. 
Ryan 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)). 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, or 382) or under section 351 
of the Public Health Service Act (42 U.S.C. 262) (see section 201(dd) 
of the FD&C Act (21 U.S.C. 321(dd))).
    Any application by Mr. Ryan for special termination of debarment 
under section 306(d)(4) of the FD&C Act should be identified with 
Docket No. FDA-2020-N-1638 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: February 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04375 Filed 3-2-21; 8:45 am]
BILLING CODE 4164-01-P