[Federal Register Volume 77, Number 66 (Thursday, April 5, 2012)]
[Notices]
[Pages 20639-20641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8229]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0659]
Shashikant Shah: Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring
Shashikant Shah for 5 years from
[[Page 20640]]
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. Shah was convicted of one count of conspiracy to commit an
offense against the United States for conduct relating to the
development and approval, including the process for development and
approval, of a drug product and to the regulation of drug products
under the FD&C Act. In addition, the type of conduct underlying the
conviction undermined the process for the regulation of drugs. Mr. Shah
was given notice of the proposed debarment and an opportunity to
request a hearing within the timeframe prescribed by regulation. Mr.
Shah failed to request a hearing, which 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 relating to the regulation of any drug product under
the FD&C Act, and 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 17, 2010, judgment was entered against Mr. Shah in the
U.S. District Court for the District of New Jersey 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.
FDA's finding that debarment is appropriate is based on the felony
conviction referenced herein. The factual basis for the conviction is
as follows: Mr. Shah was employed at Able Laboratories, Inc. (Able) as
vice president of quality assurance/quality control and regulatory
affairs from in or around mid-1999 through in or around December 27,
2004. Able developed, manufactured, and sold several generic drug
products, including products for cardiac and psychiatric conditions and
prescription pain relievers.
As Able's vice president of quality control and regulatory affairs,
Mr. Shah was responsible for supervising as many as 100 employees,
including numerous managers and supervisors, and several laboratory
chemists. Mr. Shah's other responsibilities included supervising the
quality control and testing processes of the drug products manufactured
and sold by Able, ensuring compliance with current Good Manufacturing
Practices, as required by the FD&C Act and FDA regulations.
From in or around 1999 through on or about May 19, 2005, Mr. Shah
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. Shah 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 standards of procedure 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 2002, Mr. Shah
supervised the falsification of testing data for Able's butalbital,
acetaminophen, and caffeine products. In or around 2003, Mr. Shah
supervised the falsification of testing data for Able's methylphenidate
product. Mr. Shah additionally directed and supervised the creation of
false and fraudulent entries in chemist laboratory notebooks, and in
the corresponding process validation binders, relating to Able's
abbreviated new drug application for lithium carbonate extended release
tablets, for which Able received FDA approval on or about April 21,
2003.
As a result of his conviction, on December 20, 2011, FDA sent Mr.
Shah a notice by certified mail proposing to debar him for 5 years 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(b)(2)(B)(i)(II) of the FD&C Act that Mr. Shah was
convicted of a conspiracy under Federal law for conduct relating to the
development and approval, including the process for development and
approval of a drug product, and to the regulation of drug products
under the FD&C Act, and the conduct that served as a basis for the
conviction undermined the process for the regulation of drugs. The
proposal also offered Mr. Shah 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. Shah 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 Shashikant Shah has been convicted of a conspiracy under Federal
law for conduct relating to the development and approval, including the
process for development and approval of a drug product, and to the
regulation of drug products under the FD&C Act, and that the type of
conduct that served as a basis for the conviction undermined the
process for the regulation of drugs.
As a result of the foregoing finding, Mr. Shah 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 sections 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
[[Page 20641]]
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. Shah, in any capacity during Mr. Shah'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. Shah 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. Shah during his
period of debarment (section 306(c)(1)(B) of the FD&C Act).
Any application by Mr. Shah 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-2011-N-0659 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. 2012-8229 Filed 4-4-12; 8:45 am]
BILLING CODE 4160-01-P