E9-18619. Paul H. Kornak: 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 Paul H. Kornak 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 Paul H. Kornak was convicted of three felonies 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, Mr. Kornak failed to request a hearing. Mr. Kornak'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 L. 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 January 18, 2005, the U.S. District Court for the Northern District of New York accepted Mr. Kornak's plea of guilty and entered judgment against Mr. Kornak for one count of making and using a materially false statement, one count of mail fraud, and one count of criminally negligent homicide, federal felony offenses under 18 U.S.C. 1001(a)(3), 1341 and 1346, and 13, respectively. The actions underlying these convictions were committed while Mr. Kornak was employed by the Department of Veterans Affairs as the coordinator of several clinical studies of drug products. Mr. Kornak participated in a scheme to defraud the sponsors of these studies by repeatedly submitting false documentation and enrolling and causing to be enrolled persons as study subjects who did not qualify under particular study protocols. Mr. Kornak admitted to submitting a case report form with regard to a study subject knowing the document contained materially false laboratory entries and altered information from a radiology display report, which were critical factors in determining whether the individual was eligible to participate in the clinical study. He also admitted to knowingly and willfully misrepresenting the results of a blood chemistry analysis related to the participation of a study subject who would not otherwise have met the criteria for that study. The subject was administered chemotherapeutic drugs in connection with the clinical study and died as a result thereof. Mr. Kornak's failure to perceive a substantial and unjustifiable risk that death would occur when he knowingly and willingly made and used such false documents constituted a gross deviation from the standard of care that a reasonable person would observe in the situation. Mr. Kornak further admitted to knowingly and willfully using interstate mail for the purpose of executing the aforesaid scheme and artifice to defraud, deprive, and obtain money and property.

As a result of these convictions, FDA sent Mr. Kornak 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 Mr. Kornak was convicted of felonies under Federal law for conduct relating to the development or approval of a drug product, and for conduct otherwise relating to the regulation of a drug product under the act. The proposal also offered Mr. Kornak 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. Mr. Kornak 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 Mr. Kornak has been convicted of felonies under Federal law for conduct relating to the development of 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, Mr. Kornak 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 Mr. Kornak as a consultant or contractor, or otherwise uses in any capacity the services of Mr. Kornak during Mr. Kornak'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 Mr. Kornak, 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. Kornak during his period of debarment (section 306(c)(1)(B) of the act).

Any application by Mr. Kornak for special termination of debarment under section 306(d)(4) of the act should be identified with Docket No. 2007-N-0501 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 20, 2009.

Alyson L. Saben,

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