Inspections, Compliance, Enforcement, and Criminal Investigations

FR DATE:11/13/2002

[Federal Register: November 13, 2002 (Volume 67, Number 219)]

[Notices]
[Page 68877]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no02-98]


DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00N-1529]

Elaine Yee-Ling Lai; 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 act) debarring Ms. Elaine Yee-Ling Lai 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 Ms. Lai was convicted of a felony under Federal law for aiding and abetting the making of a false document containing a materially fictitious statement in a matter within the jurisdiction of a government agency, and that Ms. Lai's conduct undermined the process for the regulation of drugs. Ms. Lai failed to request a hearing and, therefore, has waived her opportunity for a hearing concerning this action.

DATES: This order is effective November 13, 2002.

ADDRESSES: Submit applications for termination of debarment to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mary Catchings, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:

  1. Background
    On June 9, 1998, the U.S. District Court for the Central District of California accepted Ms. Lai's plea of guilty to one count of aiding and abetting the making of a false document containing a materially fictitious statement in a matter within the jurisdiction of a government agency, the FDA, in violation of 18 U.S.C. 1001(a)(3) and 2. The basis of this conviction was Ms. Lai's act in assisting the principal investigator of a clinical study in creating a fraudulent document for use by FDA to determine whether a new drug should be approved.
    As a result of this conviction, FDA served Ms. Lai by certified mail on May 13, 2002, a notice proposing to debar her for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. The proposal also offered Ms. Lai an opportunity for a hearing on the proposal. The debarment proposal was based on a finding, under section 306(b)(2)(B)(i)(II) and (a)(2) of the act (21 U.S.C. 335a(b)(2)(B)(i)(II) and (a)(2)) that Ms. Lai was convicted of a felony under Federal law for aiding and abetting the making of a false document containing a materially fictitious statement in a matter within the jurisdiction of a government agency and that Ms. Lai's conduct undermined the process for the regulation of drugs. Ms. Lai was provided 30 days to file objections and to request a hearing. Ms. Lai did not request a hearing. Her failure to request a hearing constitutes a waiver of her opportunity for a hearing and a waiver of any contentions concerning her debarment.
  2. Findings and Order
    Therefore, the Director of the Center for Drug Evaluation and Research, under section 306(b)(2) of the act, and under authority delegated to her (21 CFR 5.99), finds that Ms. Elaine Yee-Ling Lai has been convicted of a felony under Federal law for aiding and abetting the making of a false document containing a materially fictitious statement in a matter within the jurisdiction of a government agency and that Ms. Lai's conduct undermined the process for the regulation of drugs.
    As a result of the foregoing finding, Ms. Elaine Yee-Ling Lai is debarred for 5 years from providing services in any capacity to a person that has 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) (see sections 306(c)(1)(B) and (c)(2)(A)(iii) and 201(dd) of the act (21 U.S.C. 321(dd))). Any person with an approved or pending drug product application who knowingly uses the services of Ms. Lai, in any capacity during her period of debarment, will be subject to civil money penalties. If Ms. Lai, during her period of debarment, provides services in any capacity to a person with an approved or pending drug product application, she will be subject to civil money penalties. In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Ms. Lai during her period of debarment.
    Any application by Ms. Lai for termination of debarment under section 306(d)(4) of the act should be identified with Docket No. 00N- 1529 and sent to the Dockets Management Branch (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 Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

Dated: October 15, 2002.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 02-28715 Filed 11-12-02; 8:45 am]

BILLING CODE 4160-01-S

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