[Federal Register Volume 77, Number 35 (Wednesday, February 22, 2012)]
[Notices]
[Pages 10533-10534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4064]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0585]


Stephen L. Marks: Debarment Order

AGENCY: Food and Drug Administration, HHS.

[[Page 10534]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
permanently debarring Stephen L. Marks from providing services in any 
capacity to a person that has an approved or pending drug product 
application. We base this order on a finding that Mr. Marks was 
convicted of felonies under Federal law for conduct relating to the 
regulation of a drug product under the FD&C Act. Mr. Marks was given 
notice of the proposed permanent debarment and an opportunity to 
request a hearing within the timeframe prescribed by regulation. Mr. 
Marks failed to respond. Mr. Marks' failure to respond constitutes a 
waiver of his right to a hearing concerning this action.

DATES: This order is effective February 22, 2012.

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, Office of Regulatory 
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element 
Bldg., rm. 4144, Rockville, MD 20857, 301-796-4640.

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 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 23, 2011, the U.S. District Court for the Middle District 
of Pennsylvania entered judgment against Mr. Marks for: Conspiracy to 
distribute misbranded controlled substances in violation of 21 U.S.C. 
846; causing the misbranding of a drug product by dispensing a 
prescription drug product without a valid prescription in violation of 
21 U.S.C. 331(k); and aiding and abetting in a monetary transaction in 
criminally derived property of a value greater than $10,000 in 
violation of 18 U.S.C. 1957 and 2.
    FDA's finding that debarment is appropriate is based on the felony 
convictions referenced herein for conduct relating to the regulation of 
a drug product. The factual basis for this conviction is as follows: 
Mr. Marks was a pharmacist licensed to practice as a pharmacist in 
Pennsylvania. Mr. Marks managed and operated Pharmacy Services, Inc. 
(PSI, Inc.), a pharmacy registered with the Drug Enforcement 
Administration. This registration permitted Mr. Marks to fill 
prescriptions for and dispense certain controlled substances. From on 
or about June 2004, through January 2006, Mr. Marks and other employees 
of PSI, Inc. dispensed and distributed controlled substances for 
businesses that used telemarketers and Web sites to market, sell, and 
distribute controlled substances, including pain medications and 
stimulants, to individuals throughout the United States. From on or 
about June 2004, through on or about January 2006, in the Middle 
District of Pennsylvania, with intent to defraud and mislead, Mr. Marks 
did an act that caused drugs to be misbranded after they moved in 
interstate commerce and while they were held for sale, in that he 
dispensed the prescription drugs hydrocodone and Didrex, both of which 
are Schedule III controlled substances, without a valid prescription of 
a practitioner licensed by law to administer such drugs.
    As a result of his convictions, on September 30, 2011, FDA sent Mr. 
Marks 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 FD&C Act, that Mr. Marks 
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 Mr. Marks 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 October 6, 2011. 
Mr. Marks 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 FD&C Act, under 
authority delegated to the Director (Staff Manual Guide 1410.35), finds 
that Stephen L. Marks has been convicted of felonies 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. Marks 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 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), effective (see 
DATES) (see sections 306(c)(1)(B), (c)(2)(A)(ii), and 201(dd) of the 
FD&C 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 Mr. Marks, in any capacity during Mr. 
Marks' 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. Marks 
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 
(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 Mr. Marks during his period of debarment (section 306(c)(1)(A) of 
the FD&C Act (21 U.S.C. 335a(c)(1)(A))).
    Any application by Mr. Marks for special termination of debarment 
under section 306(d)(4) of the FD&C Act (21 U.S.C. 335a(d)(4)) should 
be identified with Docket No. FDA-2011-N-0585 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: February 7, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2012-4064 Filed 2-21-12; 8:45 am]
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