[Federal Register Volume 67, Number 231 (Monday, December 2, 2002)]
[Notices]
[Pages 71574-71575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30482]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1527]


Laverne M. Charpentier; Denial of Hearing; Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is denying Ms. Laverne 
M. Charpentier's request for a hearing and is issuing an order under 
the Federal Food, Drug, and Cosmetic Act (the act) debarring Ms. 
Laverne M. Charpentier 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. Charpentier was 
convicted of a felony under Federal law for conspiring to make false 
statements in matters within the jurisdiction of a Government agency, 
and that Ms. Charpentier's conduct undermined the process for the 
regulation of drugs. Ms. Charpentier has failed to file with the agency 
information and analyses sufficient to create a basis for a hearing 
concerning this action.

DATES: This order is effective December 2, 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:

I. Background

    On October 21, 1997, the U.S. District Court for the Central 
District of California accepted the plea of Ms. Laverne M. Charpentier 
to one count of conspiring to make false statements in matters within 
the jurisdiction of a Government agency under 18 U.S.C. 371 and 1001.
    Ms. Charpentier, a former drug study coordinator, was employed by a 
private company retained by drug manufacturers to conduct clinical 
studies of new pharmaceutical products to be submitted to FDA in 
support of approval of the drug products. In her capacity as a drug 
study coordinator, Ms. Charpentier participated in the conduct of 
clinical studies to test the safety and effectiveness of 
investigational new drugs. Ms. Charpentier admitted that she, among 
other things: (1) Falsely reported that certain subjects participated 
in clinical trials when in fact, they had not; (2) substituted samples 
and data from qualifying subjects for nonqualifying subjects; and (3) 
enrolled nonexistent and nonqualifying subjects in the clinical studies 
and falsified data for those nonexistent and nonqualifying subjects.
    As a result of Ms. Charpentier's conviction, FDA served her by 
certified letter on May 14, 2002, a proposal 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. Charpentier an opportunity for a hearing on the proposal. FDA based 
the debarment proposal on a

[[Page 71575]]

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. Charpentier was 
convicted of a felony under Federal law for conspiring to make false 
statements in matters within the jurisdiction of a Government agency, 
FDA, and that Ms. Charpentier's conduct undermined the process for the 
regulation of drugs.
    The certified letter also informed Ms. Charpentier that her request 
for a hearing could not rest upon mere allegations or denials, but must 
present specific facts showing that there was a genuine and substantial 
issue of fact requiring a hearing. The letter also informed Ms. 
Charpentier that if it conclusively appeared from the face of the 
information and factual analyses in her request for a hearing that 
there was no genuine and substantial issue of fact that precluded the 
order of debarment, FDA would enter summary judgment against her and 
deny her request for a hearing.
    In a letter dated May 28, 2002, Ms. Charpentier requested a hearing 
on the proposal and indicated she would submit further information to 
justify a hearing. Ms. Charpentier filed a letter dated July 1, 2002, 
in which she again requested an opportunity for a hearing. In her 
request for a hearing, Ms. Charpentier discusses her motives for her 
illegal conduct, her embarrassment and her financial problems resulting 
from her conviction. Such matters do not create a basis for a hearing 
because hearings will not be granted on mere allegations, denials, or 
general descriptions of positions and contentions, nor on data and 
information insufficient to justify the factual determination urged 
(see 21 CFR 12.24(b)(2) and (b)(3)).

II. Denial of Hearing

    In her requests for a hearing, Ms. Charpentier does not present any 
arguments or information to show why she should not be debarred. Ms. 
Charpentier acknowledges that the agency is aware of the facts and 
states that she submitted the July 1, 2002, request for a hearing to 
set forth ``some of the circumstances that led up to this unfortunate 
situation.'' Ms. Charpentier's explanation of the facts leading to her 
conviction does not raise a genuine and substantial issue of fact 
requiring a hearing.
    Ms. Charpentier is subject to permissive debarment based on: (1) 
FDA's findings that she was convicted of a Federal felony that 
undermined the regulatory process (section 306(b)(2)(B)(i)(II) and 
(a)(2) of the act)) and (2) FDA's determination that debarment is 
appropriate in this case based on a consideration of applicable factors 
set forth in section 306(c)(3) of the act. After FDA finds that the 
statutory criteria for permissive debarment has been met, the only 
relevant issue is whether Ms. Charpentier was, in fact, convicted as 
alleged in the proposal to debar. Ms. Charpentier does not dispute that 
she pled guilty to one Federal felony count for actions that undermined 
the regulation of drug products. In fact, in her letter of July 1, 
2002, Ms. Charpentier: (1) Acknowledges wrongdoing, stating that she 
made a ``big mistake''; (2) expresses her remorse; and (3) offers an 
apology for her illegal conduct. Section 306(l)(1)(B) of the act 
includes in its definition of a conviction, a guilty plea. The facts 
underlying Ms. Charpentier's conviction have been established by her 
conviction and, therefore, are not at issue. In her July 1, 2002, 
letter, Ms. Charpentier's discusses the motives resulting in her 
conviction, her remorse, her apology, and her statements indicating 
that she will not again participate in illegal activity. This 
information does not justify a hearing. Although such information may 
be considered in determining whether to grant special termination of 
debarment under section 306(d)(4)(C) of the act, this information does 
not raise a factual dispute regarding Ms. Charpentier's conviction, but 
rather supports it. Thus, FDA finds that Ms. Charpentier has failed to 
identify any genuine and substantial issue of fact requiring a hearing. 
Accordingly, FDA denies Ms. Charpentier's request for a hearing.

III. Findings and Order

    Therefore, the Deputy Commissioner, under section 306(b) of the act 
and under authority delegated to him (21 CFR 5.10), finds that Ms. 
Laverne M. Charpentier has been convicted of a felony under Federal law 
for conspiracy to make false statements to a Government agency, and 
that Ms. Charpentier's conduct undermined the process for the 
regulation of drugs.
    As a result of the foregoing findings, Ms. Laverne M. Charpentier 
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 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 December 2, 2002 (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. Charpentier, in any capacity, during her period of 
debarment, will be subject to civil money penalties. If Ms. 
Charpentier, 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. Charpentier during her 
period of debarment.
    Any application by Ms. Charpentier for termination of debarment 
under section 306(d)(4) of the act should be identified with Docket No. 
00N-1527 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: November 19, 2002.
Lester M. Crawford,
Deputy Commissioner.
[FR Doc. 02-30482 Filed 11-29-02; 8:45 am]
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