02-28256. Robert A. Fiddes; 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 Dr. Robert A. Fiddes for 20 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 Dr. Fiddes was convicted of a felony under Federal law for conspiring to make false statements to a government agency, and was a material participant in offenses for which three other people are being debarred. Dr. Fiddes has failed to request a hearing and, therefore, has waived his opportunity for a hearing concerning this action.

DATES:

This order is effective November 6, 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 September 30, 1997, the U.S. District Court for the Central District of California accepted Dr. Fiddes' plea and entered judgment against him for one count of conspiring to make false statements to a government agency, the FDA, in violation of 18 U.S.C. 371 and 1001. This conspiracy conviction was based on Dr. Fiddes participating in, directing, and encouraging the submission of false information to sponsors in required reports for clinical studies used by FDA to evaluate the safety and effectiveness of drug products.

As a result of this conviction, FDA served Dr. Fiddes by certified mail on June 6, 2002, a notice proposing to debar him for 20 years from providing services in any capacity to a person that has an approved or pending drug product application. The proposal also offered Dr. Fiddes an opportunity for a hearing on the proposal. The debarment proposal was based on findings: (1) Under section 306(b)(2)(B)(i)(II) of the act (21 U.S.C. 335a(b)(2)(B)(i)(II)) that Dr. Fiddes was convicted of a felony under Federal law for conspiracy to make false statements to a government agency and, (2) under section 306(b)(2)(B)(iii) of the act that Dr. Fiddes was a material participant in offenses leading to the conviction and debarment of three other individuals. Dr. Fiddes was provided 30 days to file objections and to request a hearing. Dr. Fiddes did not request a hearing. His failure to request a hearing constitutes a waiver of his opportunity for a hearing and a waiver of any contentions concerning his debarment.

II. Findings and Order

Therefore, the Director, Center for Drug Evaluation and Research, under section 306(b)(2)(B) of the act, and under authority delegated to her (21 CFR 5.99), finds that Dr. Robert A. Fiddes: (1) Has been convicted of a felony under Federal law for conspiring to make false statements to a government agency, and (2) was a material participant in offenses leading to the conviction and debarment of three other individuals.

As a result of the foregoing findings, Dr. Robert A. Fiddes is debarred for 20 years (4 periods of 5 years, to run consecutively, based on his conviction of a Federal felony and his role as a material participant in the offenses leading to the conviction and debarment of three other individuals) from providing services in any capacity to a person that has an approved or pending drug product application under section 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 Dr. Fiddes, in any capacity, during his period of debarment, will be subject to civil money penalties. If Dr. Fiddes, 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. In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Dr. Fiddes during his period of debarment.

Any application by Dr. Fiddes for termination of debarment under section 306(d)(4) of the act should be identified with Docket No. 00N-1526 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.