[Federal Register Volume 77, Number 66 (Thursday, April 5, 2012)]
[Notices]
[Pages 20638-20639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8233]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0330]


Ashish Macwan: 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 
Ashish Macwan 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 a finding that Mr. Macwan 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. Macwan was given notice of the proposed debarment and an 
opportunity to request a hearing within the time frame prescribed by 
regulation. Mr. Macwan 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 (HFC-230), 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

[[Page 20639]]

served as the basis for the conviction undermines the process for the 
regulation of drugs.
    On November 30, 2010, judgment was entered against Mr. Macwan in 
the United 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. Macwan was employed at Able Laboratories, Inc. (Able) 
as a chemist in Able's Quality Control Department from in or around 
mid-1999 through May 2003. In or around January 2005, Mr. Macwan was 
promoted to Assistant Manager in the Quality Control Department and was 
responsible for supervising numerous chemists, monitoring the chemists' 
compliance with current Good Manufacturing Practices, as required by 
the FD&C Act and FDA regulations. Able developed, manufactured, and 
sold several generic drug products, including products for cardiac and 
psychiatric conditions and prescription pain relievers.
    From in or around 1999 through on or about May 19, 2005, Mr. Macwan 
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, 21 U.S.C. 
331(a), and 333(a)(2).
    Mr. Macwan and his coconspirators 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 September 2003, Mr. 
Macwan falsified and manipulated testing data relating to the finished 
product testing for acetaminophen with codeine phosphate, a 
prescription pain relieving drug product. In addition, in or around 
September 2003, Mr. Macwan and his coconspirators falsified and 
manipulated testing data relating to the finished product testing for 
phentermine hydrochloride, a prescription drug developed to treat 
obesity.
    As a result of his conviction, on December 20, 2011, FDA sent Mr. 
Macwan 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. 
Macwan 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. Macwan 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. Macwan failed to request a 
hearing within the timeframe prescribed by regulation and, therefore, 
has 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 Ashish Macwan 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. Macwan 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 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. Macwan, in any capacity during Mr. 
Macwan'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. Macwan 
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. Macwan 
during his period of debarment (section 306(c)(1)(B) of the FD&C Act).
    Any application by Mr. Macwan for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2009-N-0330 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. 2012-8233 Filed 4-4-12; 8:45 am]
BILLING CODE 4160-01-P