[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]


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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.

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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 
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

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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