[Federal Register Volume 85, Number 230 (Monday, November 30, 2020)]
[Notices]
[Pages 76582-76583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26255]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4248]


Barry J. Cadden: 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 Barry J. Cadden 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. Cadden 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. Cadden 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 July 9, 
2020 (30 days after receipt of the notice), Mr. Cadden had not 
responded. Mr. Cadden'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 November 30, 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, 240-402-7500, or at 
https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of 
Enforcement, Office of Strategic Planning and Operational Policy, 
Office of Regulatory Affairs, Food and Drug Administration, 12420 
Parklawn Dr., Rockville, MD 20857, [email protected], or at 240-
402-8743.

SUPPLEMENTARY INFORMATION:

[[Page 76583]]

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 27, 2017, Mr. Cadden 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 District of 
Massachusetts, after a jury verdict, for one count of racketeering in 
violation of 18 U.S.C. 1962(c), one count of racketeering conspiracy in 
violation of 18 U.S.C. 1962(d), 52 counts of mail fraud in violation of 
18 U.S.C. 1341, and three counts of introduction of misbranded drugs 
into interstate commerce with the intent to defraud and mislead-no 
prescriptions in violation of 21 U.S.C. 353(b)(1), 331(a), and 
333(a)(2).
    As contained in counts 1-2, 4-39, 41-56, 95, and 99-100 of the 
indictment, filed on December 16, 2014, Mr. Cadden was an owner and 
director of the New England Compounding Center (NECC), which held 
itself out as a compounding-only pharmacy, and he served as NECC's 
president, head pharmacist, and Manager of Record. In addition, Mr. 
Cadden was an owner and director of Medical Sales Management, Inc. 
(MSM), and served as MSM's Treasurer. MSM provided sales and 
administrative services to NECC for which MSM was paid a service fee. 
MSM's sales representatives sold drugs on behalf of NECC to customers 
throughout the country. In those capacities, Mr. Cadden instructed the 
MSM sales force to falsely represent to customers that NECC was 
providing the highest quality compounded medications, when in fact Mr. 
Cadden, among other things, failed to properly sterilize drug products 
consistent with applicable U.S. Pharmacopeia standards, failed to test 
purportedly sterile drugs, authorized the shipping of drugs before test 
results confirming their sterility were returned, never notified 
customers of nonsterile results, and compounded drugs with expired 
ingredients. Additionally, Mr. Cadden directed and authorized the 
shipping and mailing, in interstate commerce, of contaminated 
methylprednisolone acetate to NECC customers nationwide. Mr. Cadden 
also caused drugs to be introduced and delivered into interstate 
commerce without the valid prescription of a practitioner licensed by 
law to administer drugs, which act resulted in the drugs being 
misbranded. Further, Mr. Cadden defrauded the United States by 
interfering with and obstructing the lawful governmental functions of 
FDA by claiming to be a pharmacy dispensing drugs pursuant to valid, 
patient-specific prescriptions. In fact, NECC routinely dispensed drugs 
in bulk without valid, patient-specific prescriptions.
    As a result of this conviction, FDA sent Mr. Cadden, by certified 
mail on June 2, 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. Cadden 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. Cadden 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. Cadden received the 
proposal on June 9, 2020. Mr. Cadden 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 Barry J. 
Cadden, 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, Barry J. Cadden, 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 Barry J. Cadden, 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. Cadden 
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 Mr. Cadden 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 
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 Mr. Cadden for special termination of debarment 
under section 306(d)(4) of the FD&C Act should be identified with 
Docket No. FDA-2019-N-4248 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 between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.

    Dated: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26255 Filed 11-27-20; 8:45 am]
BILLING CODE 4164-01-P