[Federal Register Volume 75, Number 35 (Tuesday, February 23, 2010)]
[Notices]
[Pages 8081-8082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-3552]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0585]


Patrick J. Lais: 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 act) permanently 
debarring Patrick J. Lais from providing services in any capacity to a 
person that has an approved or pending drug product application. We 
base this order on a finding that Mr. Lais was convicted of a felony 
under Federal law for conduct relating to the regulation of a drug 
product under the act. Mr. Lais has notified FDA that he acquiesces to 
debarment, and therefore has waived his opportunity for a hearing 
concerning this action.

DATES: This order is effective February 23, 2010.

ADDRESSES: Submit applications for special 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, 5600 Fishers Lane, 
Rockville, MD 20857, 240-632-6844.

SUPPLEMENTARY INFORMATION:

I. Background

    On April 25, 2005, Mr. Patrick J. Lais, formerly president of York 
Pharmaceutical, pleaded guilty to introducing and delivering, and 
causing to be introduced and delivered into interstate commerce, a drug 
that was adulterated within the meaning of 21 U.S.C. 351(a)(2)(B) of 
the act, a felony under Federal law in violation of 21 U.S.C. 331(a) 
and 333(a)(2). Judgment was entered against him for this felony on 
August 15, 2005. The basis for this conviction was as follows:
    Beginning in 1997 and lasting until September 2001, Mr. Lais was 
the president of York Pharmaceutical (York). Mr. Lais had 
responsibility for and authority over drug manufacturing at York. York 
manufactured generic over-the-counter drugs during the period January 
1999 through July 2001.
    York distributed in interstate commerce human drug products that 
were adulterated within the meaning of 21 U.S.C. 351(a)(2)(B) of the 
act, in that York manufactured and distributed, among other things, 
subpotent burn spray, aspirin that had failed dissolution testing, and 
antacid products contaminated with bacteria.
    Mr. Lais knew that York's manufacturing facility lacked basic 
validation processes and controls and that York's drug products were 
adulterated within the meaning of the act. Mr. Lais also knew that 
York: (1) Did not use procedures that ensured that its drugs had the 
identity, strength, quality, and purity characteristics that they were 
represented to possess; (2) did not test raw materials before using 
them; (3) did not perform appropriate laboratory determinations of 
conformance with final specifications for each of its drug products; 
(4) shipped drug product known not to meet established quality control 
criteria; (5) frequently failed to assess the stability characteristics 
of the drugs it produced; (6) did not maintain the buildings used in 
the manufacture, processing, packing, and holding of its drug products 
in a clean and sanitary condition; and (7) did not clean, maintain, and 
sanitize its manufacturing equipment and utensils in such a way as to 
prevent contamination of final drug products.
    In January 2000, York manufactured and compressed a drug product 
identified as ``Uncoated Aspirin.'' This drug failed its final 
dissolution testing. Neither Mr. Lais nor the employees under his 
authority and control determined the cause of the dissolution failure. 
Rather, York coated the failed aspirin and renumbered the lot. Part of 
this lot then was packaged as ``Coated Aspirin.'' On or about February 
21, 2000, Mr. Lais caused the shipment of 625 cases of adulterated drug 
products, identified as ``Coated Aspirin,'' to customers in Kansas 
City, MO. In May 2000, this ``Coated Aspirin'' failed 3-month stability 
testing. Mr. Lais and the employees under his authority and control did 
not determine the cause of the failure and did not inform York's 
customers that the aspirin was adulterated.

[[Page 8082]]

    Mr. Lais is subject to debarment based on a finding, under section 
306(a)(2)(B) of the act (21 U.S.C. 355a(a)(2)(B)), that he was 
convicted of a felony under Federal law for conduct relating to the 
regulation of a drug product.
    In the plea agreement entered on April 25, 2005, Mr. Lais expressly 
waived his right, if any, to contest any debarment that may be 
initiated by the Secretary of Health and Human Services under 21 
U.S.C.335a. In accordance with section 306(c)(2)(B) of the act, Mr. 
Lais notified FDA of his acquiescence to debarment in a letter signed 
on October 3, 2006. A person subject to debarment is entitled to an 
opportunity for an agency hearing on disputed issues of material fact 
under section 306(i) of the act, but by acquiescing to debarment Mr. 
Lais waived his opportunity for a hearing and to raise any contentions 
concerning his debarment.

II. Findings and Order

    Therefore, the Acting Director, Office of Enforcement, Office of 
Regulatory Affairs, under section 306(a)(2)(B) of the act, under 
authority delegated to the Acting Director (Staff Manual Guide 
1410.35), finds that Patrick J. Lais has been convicted of a felony 
under Federal law for conduct relating to the regulation of a drug 
product under the act.
    As a result of the foregoing finding and based on his notification 
of acquiescence, Mr. Lais is permanently debarred 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 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 October 3, 2006, the date of 
notification of acquiescence (see sections 306(c)(1)(B), (c)(2)(A)(ii), 
and 201(dd) of the act (21 U.S.C. 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 Patrick J. Lais, in any capacity during Mr. Lais's debarment, will 
be subject to civil money penalties (section 307(a)(6) of the act (21 
U.S.C. 335b(a)(6))). If Mr. Lais 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 act). In addition, FDA will not accept or 
review any abbreviated new drug applications submitted by or with the 
assistance of Mr. Lais during his period of debarment (section 
306(c)(1)(B) of the act).
    Any application by Mr. Lais for special termination of debarment 
under section 306(d)(4) of the act should be identified with Docket No. 
FDA-2009-N-0585 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: January 26, 2010.
Brenda Holman,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2010-3552 Filed 2-22-10; 8:45 am]
BILLING CODE 4160-01-S