[Federal Register Volume 77, Number 66 (Thursday, April 5, 2012)]
[Notices]
[Pages 20641-20642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8249]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0331]
Jose Concepcion: Debarment Order
AGENCY: Food and Drug Administration, HHS.
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) debarring
Jose Concepcion for 5 years from providing services in any capacity to
a person that has an approved or pending drug product application. FDA
bases this order on findings that Mr. Concepcion was convicted of
conspiracy to commit an offense against the United States, that the
conduct that served as the basis for the felony conspiracy conviction
relates to the development or approval, including the process for
development or approval, of any drug product and relates to the
regulation of drug products under the FD&C Act, and that the type of
conduct underlying the conviction undermines the process for the
regulation of drugs. Mr. Concepcion was given notice of the proposed
debarment and an opportunity to request a hearing within the timeframe
prescribed by regulation. Mr. Concepcion failed to request a hearing.
Mr. Concepcion's failure to request a hearing constitutes a waiver of
his right to a hearing concerning this action.
DATES: This order is effective April 5, 2012.
ADDRESSES: Submit applications for 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(b)(2)(B)(i)(II) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(II)) permits FDA to debar an individual if it finds
that the individual has been convicted of a conspiracy to commit a
felony under Federal law for conduct relating to the development or
approval, including the process for development or approval, of any
drug product or otherwise relating to the regulation of a drug product
under the FD&C Act, if FDA finds that the type of conduct that served
as the basis for the conviction undermines the process for the
regulation of drugs.
On December 1, 2010, based upon a plea of guilty to one count of
conspiracy to commit an offense against the United States, in violation
of 18 U.S.C. 371, judgment was entered against Mr. Concepcion in the
U.S. District Court for the District of New Jersey.
FDA's finding that debarment is appropriate is based on the
conspiracy conviction referenced herein. The factual basis for the
conviction is as follows: Mr. Concepcion was employed at Able
Laboratories, Inc. (Able) from mid-1998 until January 2005. Able
developed, manufactured, and sold several generic drug products,
including products for cardiac and psychiatric conditions and
prescription pain relievers. Mr. Concepcion was employed as a chemist
in the Quality Control Department performing analytical tests on Able
products to ensure product safety and effectiveness from in or around
mid-1998 to around January 2001. In or around January 2001, Mr.
Concepcion was promoted to group leader and around April 2002, he was
promoted to supervisor in the Quality Control Department.
As group leader and supervisor in the Quality Control Department,
Mr. Concepcion's responsibilities included supervising numerous
chemists and technicians who performed analytical quality control tests
on Able's generic drug products to ensure product safety and
effectiveness; monitoring the chemists' compliance with current Good
Manufacturing Practices, as required by the FD&C Act and FDA
regulations; and ensuring compliance with Able's standard operating
procedures (SOPs).
From in or around 1999 through January, 2005, Mr. Concepcion
conspired to cause the introduction and delivery for introduction into
interstate commerce of a drug that was adulterated and misbranded, with
an intent to defraud and mislead, contrary to 18 U.S.C. 371 and 21
U.S.C. 331(a) and 333(a)(2).
Mr. Concepcion and his co-conspirators impaired, impeded, defeated,
and obstructed FDA's lawful government function to approve the
manufacture and distribution of generic drug products by violating Good
Manufacturing Practices; violating SOPs by failing to properly
investigate, log, and archive questionable, aberrant, and unacceptable
laboratory results so that Able could conceal improprieties and
continue to distribute and sell its drug products; manipulating and
falsifying testing data and information to conceal from FDA failing
laboratory results relating to Able's generic drug products; creating
and maintaining false, fraudulent, and inaccurate test results to make
it appear that drug products had the requisite identity, strength,
quality, and purity characteristics so the drug products could be
distributed and sold to increase Able's sales and profit; and creating
and maintaining false, fraudulent, and inaccurate data and records to
obtain FDA approval to market new product lines.
In furtherance of the conspiracy, in or around December 2001, Mr.
Concepcion and his co-conspirators falsified and manipulated testing
data relating to stability tests for propoxphene napsylate and
acetaminophen.
As a result of his conviction, on January 6, 2012, FDA sent Mr.
Concepcion a notice by certified mail proposing to debar him for 5
years from providing services in any capacity to a
[[Page 20642]]
person that has an approved or pending drug product application. The
proposal was based on a finding, under section 306(b)(2)(B)(i)(II) of
the FD&C Act, that Mr. Concepcion was convicted of conspiracy to commit
an offense against the United States, that the conduct that served as
the basis for the felony conspiracy conviction relates to the
development or approval, including the process for development or
approval, of any drug product and relates to the regulation of drug
products under the FD&C Act, and that the conduct that served as a
basis for the conviction undermines the process for the regulation of
drugs. The proposal also offered Mr. Concepcion 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. Mr. Concepcion
failed to request a hearing within the timeframe prescribed by
regulation and has, therefore, waived his opportunity for a hearing and
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(b)(2)(B)(i)(II) of the FD&C Act
under authority delegated to him (Staff Manual Guide 1410.35), finds
that Jose Concepcion has been convicted of a felony under Federal law
for conduct relating to the regulation of a drug product under the FD&C
Act, and that the type of conduct that served as a basis for the
conviction undermines the process for the regulation of drugs.
As a result of the foregoing finding, Mr. Concepcion is debarred
for 5 years 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 section 306(c)(1)(B), (c)(2)(A)(iii), and 201(dd) of the
FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(iii), 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. Concepcion, in any capacity during
Mr. Concepcion's 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.
Concepcion 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 submitted by or with the
assistance of Mr. Concepcion during his period of debarment (section
306(c)(1)(B) of the FD&C Act).
Any application by Mr. Concepcion for termination of debarment
under section 306(d)(1) of the FD&C Act (21 U.S.C. 355a(d)(1)) should
be identified with Docket No. FDA-2009-N-0331 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: March 27, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2012-8249 Filed 4-4-12; 8:45 am]
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