E9-18621. Kim C. Hendrick: 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) permanently debarring Kim C. Hendrick, M.D., from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Hendrick was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product, and for conduct otherwise relating to the regulation of a drug product under the act. After being given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, Dr. Hendrick failed to request a hearing. Dr. Hendrick's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.

DATES:

This order is effective August 4, 2009.

ADDRESSES:

Submit applications for special 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:

Robert Hummel, Sr., Division of Compliance Policy (HFC-230), Office of Enforcement, Office of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240-632-6845.

SUPPLEMENTARY INFORMATION:

I. Background

Section 306(a)(2)(A) of the act (21 U.S.C. 335a(a)(2)(A)) requires debarment of an individual if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product. Section 306(a)(2)(B) of the act requires debarment of an individual if FDA finds that the individual has been convicted of a felony under Federal law for conduct otherwise relating to the regulation of any drug product under the act.

On September 11, 2007, the U.S. District Court for the Eastern District of Michigan accepted Dr. Hendrick's guilty plea and entered judgment against him for one count of mail fraud, a federal felony offense under 18 U.S.C. 1341. This offense was committed when Dr. Hendrick was a licensed physician practicing medicine in the State of Michigan. Dr. Hendrick agreed to participate in the clinical research trial for Augmentin XR, including its use in the treatment of adults with Acute Bacterial Sinusitis (ABS). As part of his participation in the clinical study, he agreed to conduct the study in conformity with the protocol established by GlaxoSmithKline and to comply with FDA regulations. He also agreed to take X-rays, before and after treatment, of persons he diagnosed with ABS, and to have an independent radiologist analyze these and issue reports regarding the X-rays.

Dr. Hendrick admitted that instead of having an independent radiologist review the X-rays and issue reports, he allowed certain X-rays to be sent in batch form, which was a direct violation of the protocol. Further, he did not verify the purported signatures of the independent radiologist reports and, instead, failed to disclose to GlaxoSmithKline and/or FDA that the signatures were unverified and possibly forged, with the intent to create a false impression of a state of facts. Dr. Hendrick was paid by GlaxoSmithKline approximately $116,800 in X-ray fees for his participation in the clinical research trial. In so doing he caused a check to be mailed to him through the Postal Service at the direction of GlaxoSmithKline as partial payment for his participation in the clinical trial for the purpose of executing the scheme to defraud.

As a result of this conviction, FDA sent Dr. Hendrick by certified mail on May 4, 2009, a notice proposing to permanently debar him from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding, under section 306(a)(2)(A) and (a)(2)(B) of the act, that Dr. Hendrick was convicted of a felony under Federal law for conduct relating to the development or approval of a drug product, including the process for development or approval of a drug product, and conduct otherwise relating to the regulation of a drug product under the act. The proposal also offered Dr. Hendrick an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Dr. Hendrick did not request a hearing and has, therefore, waived his opportunity for a hearing and any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

Therefore, the Acting Director, Office of Enforcement, Office of Regulatory Affairs, under section 306(a)(2)(A) and (a)(2)(B) of the act, and under authority delegated to the Acting Director (Staff Manual Guide 1410.35), finds that Dr. Hendrick has been convicted of a felony under Federal law for conduct relating to the development or approval of a drug product, including the process for development or approval, of a drug product, and conduct otherwise relating to the regulation of a drug product under the act.

As a result of the foregoing finding, Dr. Hendrick 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) (see sections 306(c)(1)(B) and (c)(2)(A)(ii) and 201(dd) of the act (21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii), and 321(dd)). Any person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses the services of Dr. Hendrick, in any capacity, during Dr. Hendrick's permanent debarment, will be subject to civil money penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6))). If Dr. Hendrick, 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 Dr. Hendrick during his permanent debarment (section 306(c)(1)(B) of the act).

Any application by Dr. Hendrick for special termination of debarment under section 306(d)(4) of the act should be identified with Docket No. FDA-2008-N-0582 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: July 15, 2009.

Alyson L. Saben,

Acting Director, Office of Enforcement, Office of Regulatory Affairs.