E7-1416. James T. Kimball; Denial of Hearing; Final Debarment Order

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is denying Mr. James T. Kimball's request for a hearing and is issuing a final order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Mr. James T. Kimball 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 Mr. Kimball was convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the act. In addition, Mr. Kimball 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 January 30, 2007.

ADDRESSES:

Submit applications for 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:

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 May 24, 2000, a jury found Mr. Kimball guilty of one count of conspiring to commit offenses against the United States and the Florida Department of Health, a Federal felony offense under 18 U.S.C. 371; six counts of distributing a misbranded drug into interstate commerce, a Federal felony offense under 21 U.S.C. 331(a); and one count of making a false statement in a matter within the jurisdiction of a Federal agency, a Federal felony offense under 18 U.S.C. 1001. On October 19, 2000, the U.S. District Court for the Middle District of Florida entered judgment and sentenced Mr. Kimball for these offenses.

The bases for these convictions were Mr. Kimball's knowing and willful participation, including conspiring, to violate Federal laws in connection with the distribution of a misbranded drug, deprenyl, into interstate commerce, and false statements he made to the U.S. Customs Service about shipments of deprenyl for export. The drug deprenyl was misbranded because it contained selegiline, the active ingredient of a prescription drug Eldepryl, but was dispensed without a prescription issued by a licensed practitioner.

As a result of these convictions, FDA served Mr. Kimball by certified letter on April 25, 2005,^[1] a proposal to permanently debar him from providing services in any capacity to a person that has an approved or pending drug product application. The notice also offered Mr. Kimball an opportunity to request a hearing on the debarment proposal. The debarment proposal was based on a finding, under section 306(a)(2)(B) of the act (21 U.S.C. 335a(a)(2)(B)), that Mr. Kimball was convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the act.

The certified letter also informed Mr. Kimball that his 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 Mr. Kimball that the only material issue of fact was whether he was convicted as alleged in the letter, and that the facts underlying his conviction are not at issue in this proceeding. Finally, the letter informed Mr. Kimball that if it conclusively appeared from the face of the information and factual analyses in his 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 him and deny his request for a hearing.

In a letter dated May 16, 2005, Mr. Kimball responded to the certified letter by requesting a hearing.

II. Denial of Hearing

In his May 16, 2005, request for a hearing, Mr. Kimball does not present any arguments or information to show why he should not be debarred. Mr. Kimball merely states that: (1) He “was not convicted pursuant to the statements set forth in FDA's alleged notice”, (2) the allegations of his convictions are incorrect, and (3) his conviction does not mandate his debarment. Such statements do not create a basis for a hearing because hearings will not be granted on mere allegations, denials, or general descriptions of positions (see 21 CFR 12.24(b)(2)). Although FDA's proposal to debar Mr. Kimball explained that he had the opportunity to file a request for a hearing and then submit factual information within 60 days from receipt of the letter, Mr. Kimball did not submit any factual information. Mr. Kimball has failed to present any arguments or information to show why he should not be debarred. Therefore, FDA finds that Mr. Kimball has failed to identify any genuine and substantial issue of fact requiring a hearing. Accordingly, FDA denies Mr. Kimball's request for a hearing.

III. Findings and Order

Therefore, the Associate Commissioner for Regulatory Affairs, under section 306(a) of the act and under authority delegated to him, finds that Mr. James T. Kimball has been convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the act (section 306(a)(2)(B) of the act).

As a result of the foregoing findings, Mr. James T. Kimball 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 (see DATES) (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 Mr. Kimball in any capacity, during his period of debarment, will be subject to civil money penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6))). If Mr. Kimball, during his period of debarment, provides services in any capacity to a person with an approved or pending drug product application, 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. Kimball during his period of debarment.

Any application by Mr. Kimball for termination of debarment under section 306(d)(4) of the act should be identified with Docket No. 2005N-0105 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 22, 2007.

Margaret O'K. Glavin,

Associate Commissioner for Regulatory Affairs.

Footnotes

1.  The certified letter was mailed to the prison facility where records indicated that Mr. Kimball was incarcerated, and the return receipt was signed on April 25, 2005, by an employee at the facility. In his request for hearing, Mr. Kimball stated that he received the letter on May 5, 2005. The delivery dates do not alter the nature of Mr. Kimball's request for a hearing or our application of summary judgement in this matter.