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Court Updates and Other Enforcement Activities continued 2001

Chapter 7

Last Update: August 07, 2003

Debarment List

Persons may be debarred from working for the drug industry if they are convicted of committing crimes related to drug products regulated by the Food and Drug Administration. During Fiscal Year 2001, no notices were published in the FEDERAL REGISTER concerning persons debarred pursuant to sections 306(a) and (b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 335(a) and (b)):

No individual was debarred in Fiscal Year 2001.

Permanent ^*
Permanent ^#
FIRM: None (as of the latest Federal Register date on this list).

SYMBOLIC NOTATIONS:
^ Mandatory Debarment (Sec. 306(a))
% Permissive Debarment (Sec. 306(b))
* Hearing requested and denied.
# Acquiesced to Debarment.
+ Special Termination of Debarment (Sec. 306(d)(4)(C) and (D))

A complete debarment list is available on the Internet at: http://www.fda.gov/ora/compliance_ref/debar/debar.txt

The debarment list is compiled in accordance with 21 U.S.C. § 335a(e) from notices published in the Federal Register (FR). The name of the firm or individual appearing in the FR for the first time is added to the end of the list. Subsequently published FR debarment notices concerning the same firm or person are posted after the listing of the firm or individual.

DISQUALIFIED/TOTALLY RESTRICTED LIST FOR CLINICAL INVESTIGATORS

FDA regulates scientific studies that are designed to develop evidence to support the safety and effectiveness of investigational drugs (human and animal), biological products, and medical devices. Physicians and other qualified experts ("clinical investigators") who conduct these studies are required to comply with applicable statutes and regulations intended to ensure the integrity of clinical data on which product approvals are based and to help protect the rights, safety, and welfare of human subjects.

The following list contains the names of all clinical investigators who have been disqualified or "totally restricted" in Fiscal Year 2001. FDA may disqualify a clinical investigator if the clinical investigator has repeatedly or deliberately failed to comply with applicable regulatory requirements or the clinical investigator has repeatedly or deliberately submitted false information to the sponsor or, if applicable, to FDA. A disqualified clinical investigator is not eligible to receive investigational drugs, biologics, or devices. In the past, the phrase "totally restricted" was also used to refer to clinical investigators who had been disqualified. Where an investigator has been reinstated, it is so noted.

It is important to underscore the difference between "totally restricted" clinical investigators and "restricted" clinical investigators. "Totally restricted" investigators are ineligible to receive investigational products (absent reinstatement). "Restricted" investigators, on the other hand, are still eligible to receive investigational products, provided they conduct regulated studies in accordance with the restrictions specified in their agreement with FDA and all applicable regulatory requirements.

FDA maintains separate lists for all clinical investigators who have agreed to certain restrictions with respect to their conduct of FDA regulated studies; and clinical investigators who have provided adequate assurances with respect to their future (http://www.fda.gov/ora/compliance_ref/bimo/dis_res_assur.htm).

These lists are updated regularly. For further information about these lists, contact: Jim McCormack, Food and Drug Administration, Office of Enforcement, 5600 Fishers Lane, HFC-230, Rockville, MD 20857; phone: 301-827-0425, e-mail jmccorma@ora.fda.gov, fax: 301-827-0482.

FDA also makes available a separate list of firms or persons debarred pursuant to the debarment provisions of the Federal Food, Drug, and Cosmetic Act (http://www.fda.gov/ora/compliance_ref/debar/default.htm).

In addition, the DHHS, Public Health Service, Office of Research Integrity, Administrative Actions Listing is located at: http://silk.nih.gov/public/cbz1bje.@www.orilist.html

Disqualified/Totally Restricted ListD= disqualified or totally restricted clinical investigatorswho are not eligible to receive investigational products.

Name Address
James A. Halikas Minneapolis, MN
Center
CDER
Type
D
Action
January 15, 2001
Comments
Disqualified through hearing process

 

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