[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Notices]
[Pages 71042-71043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-29538]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0377]


Scott S. Reuben: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an

[[Page 71043]]

order under the Federal Food, Drug, and Cosmetic Act permanently 
debarring Scott S. Reuben, M.D. 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. Reuben was convicted of a 
felony under Federal law for conduct relating to the regulation of a 
drug product under the Federal Food, Drug, and Cosmetic Act. Dr. Reuben 
was given notice of the proposed permanent debarment and an opportunity 
to request a hearing within the timeframe prescribed by regulation. Dr. 
Reuben failed to respond. Dr. Reuben's failure to respond constitutes a 
waiver of his right to a hearing concerning this action.

DATES: This order is effective November 16, 2011.

ADDRESSES: Submit applications for special termination of debarment to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Compliance 
Policy (HFC-230), Office of Enforcement, Office of Regulatory Affairs, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
(301) 796-4640.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 335a(a)(2)(B)) requires debarment of an individual 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 Federal Food, Drug, and Cosmetic Act.
    On June 24, 2010, the U.S. District Court for the District of 
Massachusetts entered judgment against Dr. Reuben for health care fraud 
in violation of 18 U.S.C. 1347.
    The FDA's finding that debarment is appropriate is based on the 
felony conviction referenced herein for conduct relating to the 
regulation of a drug product. The factual basis for this conviction is 
as follows: Dr. Reuben was a physician licensed by the State of 
Massachusetts working as an anesthesiologist providing anesthesia 
services to patients in connection with surgeries, and also treating 
patients post-surgery in the District of Massachusetts. Dr. Reuben 
served as the chief of acute pain at a hospital in Western 
Massachusetts and maintained an office at the hospital for the purpose 
of conducting research. Dr. Reuben's interest, from a research 
perspective, was in post-operative multimodal analgesia therapy. Dr. 
Reuben made proposals for research funding to pharmaceutical companies 
that manufactured drugs that he used or proposed to use in multimodal 
analgesia therapy. Dr. Reuben represented to the companies that, as the 
principal investigator, he would be performing clinical studies with 
actual patients to whom he would administer the drug that was the 
subject of the research grant.
    Dr. Reuben entered into contracts to perform research studies 
funded by the companies from at least as early as 1999. Dr. Reuben 
purported to perform the research called for by the contracts, and 
published articles in various medical journals based on the purported 
results of the research, when in fact those studies had not been 
performed, and therefore the research results reported in the medical 
journals were false.
    As a result of his convictions, on August 22, 2011, FDA sent Dr. 
Reuben a notice by certified mail 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 Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 335a(a)(2)(B)), that Dr. Reuben was convicted 
of a felony under Federal law for conduct relating to the regulation of 
a drug product under the Federal Food, Drug, and Cosmetic Act. This 
conclusion was based on the fact that FDA regulates clinical trials 
related to drug products such as those described previously as part of 
the Agency's regulation of drug products. The proposal also offered Dr. 
Reuben 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 a waiver of 
the opportunity for a hearing and of any contentions concerning this 
action. The proposal was received on August 26, 2011. Dr. Reuben failed 
to respond within the timeframe prescribed by regulation and has, 
therefore, waived his opportunity for a hearing and has waived any 
contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement, Office of 
Regulatory Affairs, under section 306(a)(2)(B) of the (21 U.S.C. 
335a(a)(2)(B)) of the Federal Food, Drug, and Cosmetic Act, under 
authority delegated to the Director (Staff Manual Guide 1410.35), finds 
that Scott S. Reuben has been convicted of a felony under Federal law 
for conduct relating to the regulation of a drug product under the 
Federal Food, Drug, and Cosmetic Act.
    As a result of the foregoing finding, Dr. Reuben is permanently 
debarred from providing services in any capacity to a person with an 
approved or pending drug product application under sections 505, 512, 
or 802 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 
360b, or 382), or under section 351 of the Public Health Service (42 
U.S.C. 262), effective (see DATES) (see section 306(c)(1)(B), 
(c)(2)(A)(ii), and 201(dd) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(ii), and 321(dd))). 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 Dr. Reuben, in any capacity during Dr. Reuben's debarment, 
will be subject to civil money penalties (section 307(a)(6) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335b(a)(6))). If Dr. 
Reuben 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 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335b(a)(7)). In 
addition, FDA will not accept or review any abbreviated new drug 
applications submitted by or with the assistance of Dr. Reuben during 
his period of debarment (section 306(c)(1)(A) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 335a(c)(1)(A))).
    Any application by Dr. Reuben for special termination of debarment 
under section 306(d)(4) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 335a(d)(4)) should be identified with Docket No. FDA-2011-N-0377 
and sent to the Division of Dockets Management (see ADDRESSES). All 
such submissions are to be filed in four copies. The public 
availability of information in these submissions is governed by 21 CFR 
10.20(j).
    Publicly available submissions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 7, 2011.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-29538 Filed 11-15-11; 8:45 am]
BILLING CODE 4160-01-P