FR DATE:12/02/2002

[Federal Register: December 2, 2002 (Volume 67, Number 231)]

[Notices]               

[Page 71574-71575]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr02de02-98]                         





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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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