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Updated: 2008-12-29

DISQUALIFIED/TOTALLY RESTRICTED LIST FOR CLINICAL INVESTIGATORS

FDA regulates scientific studies that are designed to develop evidence to support the safety and effectiveness of investigational drugs (human and animal), biological products, and medical devices. Physicians and other qualified experts ("clinical investigators") who conduct these studies are required to comply with applicable statutes and regulations intended to ensure the integrity of clinical data on which product approvals are based and, for research involving human subjects, to help protect the rights, safety, and welfare of those subjects.

The following list contains the names of all clinical investigators who have been disqualified or "totally restricted." FDA may disqualify a clinical investigator if the clinical investigator has repeatedly or deliberately failed to comply with applicable regulatory requirements or the clinical investigator has repeatedly or deliberately submitted false information to the sponsor or, if applicable, to FDA. A disqualified clinical investigator is not eligible to receive investigational drugs, biologics, or devices. In the past, the phrase "totally restricted" was also used to refer to clinical investigators who had been disqualified. Where an investigator has been reinstated, it is so noted.

It is important to underscore the difference between "totally restricted" clinical investigators and "restricted" clinical investigators. "Totally restricted" investigators are ineligible to receive investigational products (absent reinstatement). "Restricted" investigators, on the other hand, are still eligible to receive investigational products, provided they conduct regulated studies in accordance with the restrictions specified in their agreement with FDA and all applicable regulatory requirements.

FDA maintains separate lists for all clinical investigators who have agreed to certain restrictions with respect to their conduct of FDA regulated studies; clinical investigators who were previously subject to restrictions which have been removed; and clinical investigators who, under regulations in effect until 1987, provided adequate assurances with respect to their future compliance with requirements applicable to the use of investigational drugs and biologics (http://www.fda.gov/ora/compliance_ref/bimo/dis_res_assur.htm). These lists are updated regularly. For further information about these lists, contact the program coordinator.

FDA also makes available a separate list of firms or persons debarred pursuant to the debarment provisions of the Federal Food, Drug, and Cosmetic Act (http://www.fda.gov/ora/compliance_ref/debar/default.htm)

In addition, the DHHS, Public Health Service, Office of Research Integrity, Administrative Actions Listing is located at: http://ori.hhs.gov/misconduct/AdminBulletinBoard.shtml

List dated: 06/02/2000 (Edited 04/02/2002)
List revised: 10/16/2002 (Added E. Caro Acevedo)
List revised: 04/10/2003 (Added Roy C. Page)
List revised: 05/23/2003 (Added Joseph L. Williams)
List revised: 10/17/2003 (Added C. P. Mathew; A. M. Norman)
List revised: 02/23/2004 (Added: DeAbate, Carl Andrew)
List revised: 10/13/2004 (Added: Marcus, Eugenia)
List revised: 01/14/2005 (Added: Anderson, Roger D.)
List revised: 10/31/2005 (Added: Jeffrey L. McLeod)
List revised: 11/17/2005 (Added: Harry F. Farber )
List revised: 12/15/2005 (Corrected Initial to: Harry F. Farber )
List revised: 10/11/2006 (Added: Christopher Phillips)
List revised: 10/23/2006 (Added: Peter K. Law, Ph.D.)
List revised: 08/30/2007 (Added: Daniel Bigg)
List revised: 01/31/2008 (Added: Jamie Kapner, M.D.)
List revised: 02/15/2008 (Added: Bertrand Agus, M.D.)
List revised: 02/25/2008 (Added: Stephen D. Rossner, M.D.)
List revised: 03/05/2008 (Added: William H. Ziering, M.D.)
List revised: 03/05/2008 (Added: Mary Sawaya)
List revised: 03/21/2008 (Added: Patrick J. Daley)
List revised: 04/28/2008 (Added: Manjeet Kaur Achreja, M.D.)
List revised: 05/06/2008 (Added: David N. Lofgren, M.D.)
List revised: 05/15/2008 (Added: James C. Vestal, M.D.)
List revised: 06/02/2008 (Added: Maria Anne Kirkman Campbell, M.D.)
List revised: 07/03/2008 (Updated: CBER Action dates for Lieberman, Roberts, Slazinski, & Tewari).
List revised: 8/6/2008 (Added: Gentry).
List revised: 8/27/2008 (Added: Guy).
List revised: 9/02/2008 (Added: Holland).
List revised: 10/24/2008 (Added: Peggy Ann Garjian, M.D.).
List revised: 12/29/2008 (Updated: CDER Action Dates for Khooblall & McLeod ).
Disqualified/Totally Restricted List

Type
D Disqualified or totally restricted clinical investigators
who are not eligible to receive investigational products.
DR Reinstated
R Restricted
 
Name Address Center Type Action Date Comments
WILLIAM A ABRUZZI JR, MD WAPPINGERS FALS, NY CDER D 31-AUG-1966 Through hearing process
EDUARDO CARO ACEVEDO, MD BAYAMON, PR CDER D 30-JUL-2002 Through hearing process
MANJEET KAUR ACHREJA, MD SEAGROVE, NC CDER D 24-APR-2008 By consent agreement
BERTRAND AGUS, MD NEW YORK, NY CDER D 12-FEB-2008 By consent agreement
ALLAN R ALLBRITTON GONZALES, LA CVM D 24-JAN-1997 By consent agreement
WILBERT S ARONOW, MD OMAHA, NE CDER R 8-OCT-1982 Total
BRADY L ALLEN, MD DALLAS, TX CDER D 11-DEC-1990 By consent agreement
ROGER D. ANDERSON, MD PITTSBURGH, PA CDER D 10-JAN-2005 By consent agreement
CHAOVANEE AROONSAKUL,MD CHICAGO, IL CDER D 16-OCT-1991 Through hearing process
HOWARD BALIN, MD PHILADELPHIA, PA CDER D 19-MAR-1975 Through hearing process
VINCENT J BARATTA, MD N LINDENHURST, NY CDER D 13-NOV-1985 Through hearing process
SHELDON R BENDER, MD PHILADELPHIA, PA CDER D 17-FEB-1969 Through hearing process
DANIEL BIGG
CHICAGO, IL 		CBER D 18-MAY-2007 By consent agreement.
CARL E BLUNCK JR, MD PLAQUEMINE, LA CDER D 07-JUL-1979 Through hearing process
RICHARD L BORISON, MD AUGUSTA, GA CDER D 10-NOV-1998 By consent agreement
CHETWYND E BOWLING, MD PHILADELPHIA, PA CDER D 13-NOV-1980 Through hearing process
PAUL W BOYLES, MD CARY, NC CDER D 13-APR-1995 Through hearing process
WALTER C BRUSCHI, MD LEAVENWORTH, KS CDER R 28-JUN-1983 Total
WALTER J BUSHNELL, MD DENVER, CO CDER D 16-SEP-1988 By consent agreement
MARIA ANNE KIRKMAN CAMPBELL, MD ALABAMA CDER D 8-MAY-2008 Total
THOMAS N CARTER, MD BETHESDA, MD CDER D 10-JUN-1980 By consent agreement
CHARLES CARTER, MD ORLANDO, FL CDER DR 31-AUG-1966 (Reinstated 29-JUL-1969) Through hearing process
WALTER A CARUSO, MD MT KISCO, NY CDER R 28- JUL-1988 Total
LEO CASS, MD CAMBRIDGE, MA CDER D 15-DEC-1965 Through hearing process
JOSEPH R CATALDO, MD ALEXANDRIA, VA CDER R 14-APR-1982 Total
ABRAHAM A CHAPLAN, MD ENGLEWOOD, NJ CDER D 28-FEB-1979 Through hearing process
JOHN H CLOSE, MD MIAMI, FL CDER D 19-JUL-1978 Through hearing process
HERBERT W COPELAN, MD PHILADELPHIA, PA CDER DR 19-JUL-1966 (Reinstated 19-AUG-1966) Through hearing process
DANIEL L CRANE, MD NEW YORK, NY CDER D 27-JUN-1984 By consent agreement
AUBREY P CULLEN, MD HOUSTON, TX CDER R 08-JUN-1987 Total
PATRICK J. DALEY, MD TULSA, OK CBER D 14-MAR-2008 Total
FRED C DALTON, MD MINEOLA, NY CDER D 03-JAN-1979 Through hearing process
PHILLIP L DAY, MD SAN ANTONIO, TX CDER D 28-AUG-1975 Through hearing process
CARL ANDREW DeABATE, MD WASHINGTON, DC CDER D 05-FEB-2004 By consent agreement
BRUCE I DIAMOND, PHD AUGUSTA, GA CDER D 10-FEB-1999 By consent agreement
WILLIAM L DOSS JR, MD DETROIT, MI CDER D 14-JUN-1979 Through hearing process
DAVID M DRESSLER, MD NEW BRITAIN, CT CDER D 14-MAR-1984 By consent agreement
EDWIN DUNLOP, MD ATTLEBORO, MA CDER DR 16-FEB-1970 (Reinstated 24-DEC-1970) Through hearing process
HAROLD F. FARBER, MD NARBERTH, PA AND PHILADELPHIA, PA   D 18-JUL-2005 By plea agreement
SAMUEL I FEURST, MD VICKSBURG, MS CDER D 02-OCT-1984 By consent agreement
ROBERT A FIDDES, MD WHITTIER, CA CDER D 01-JUN-1999 Through hearing process
ROBERT FOGARI, MD JERSEY CITY, NJ CDER R 24-APR-1985 Total
ROBERT A FOX JR, MD BRANFORD, CT CDER D 15-FEB-1989 By consent agreement
WILLIAM C FRANKLIN, MD HOUSTON, TX CDER D 09-NOV-1982 By consent agreement
EDWARD C FRONING, MD SAN MATEO, CA CDER D 10-APR-1976 Through hearing process
RONALD R FULLER NEWARK, OH CVM D 29-JAN-1988 Through hearing process
MIGUEL H GAMARRA, MD CORAL GABLES, FL CDER D 31-MAY-1983 By consent agreement
FLOYD K GARETZ, MD MINNEAPOLIS, MN CDER D 23-NOV-1982 By consent agreement
BARRY D GARFINKEL, MD MINNEAPOLIS, MN CDER R 14-MAY-1994 Total
PEGGY ANN GARJIAN, MD BROOKLYN , NY CDER D 22-SEPT-2008 By consent agreement
ROBERT A GATENBY, MD PHILADELPHIA, PA CDER D 15-NOV-1988 By consent agreement
LAYNE O GENTRY, MD HOUSTON, TX CDER D 18-JUN-2008 Total
LARRIAN GILLESPIE, MD LOS ANGELES, CA CDER D 02-FEB-1989 By consent agreement
JOHN M GOODING, DO PANAMA CITY, FL CDER R 07-NOV-1986 Total
EUGENE O GRECU, MD SACRAMENTO, CA CDER D 25-MAR-1999 Through hearing process
BERNARD K GUERIN, MD RENO, NV CDER D 13-NOV-1984 By consent agreement

MATTHEW J. GUY, MD, ROCKAWAY PARK, NY

 CDER D

25-JUL-2008

By consent agreement
JAMES A. HALIKAS MINNEAPOLIS, MN CDER D 15-JAN-2001 Through hearing process

JAMES A. HOLLAND, MD THOMASVILLE, GA

 CDER D

25-AUG-2008

Total
DWIGHT J HOTCHKISS JR, MD FLEMINGTON, NJ CDER D 25-JUN-1984 Through hearing process
J T JOHN JR, MD NASHVILLE, TN CDER D 04-NOV-1983 By consent agreement
Jamie Kapner, MD SCOTTSDALE, AZ CDER D 10-SEP-2007 By consent agreement
KHEM L KHOOBLALL, MD PARMA, OH CDER D 17-JUN-1998 By consent agreement
RONALD KLEBER, MD MARIETTA, GA CDER D 06-AUG-1981 Through hearing process
ALBERT M KLIGMAN, MD CONSHOHOCKEN, PA CDER DR 19-JUL-1966 (Reinstated 19-AUG-1966) Through hearing process
NATHAN S KLINE, MD NEW YORK, NY CDER D 13-NOV-1980 Through hearing process
RICHARD B KNAPP, MD MORGANTOWN, WV CDER D 04-NOV-1982 By consent agreement
PAUL KORNBLITH, MD BRONX, NY CBER D 25-NOV-1991 By consent agreement
CONSTANTINE I KOSTAS, MD LYNNFIELD, MA CDER D 07-OCT-1986 By consent agreement.
MORTON L KURLAND, MD RANCHO MIRAGE, CA CDER D 06-NOV-1978 Through hearing process
LEON C. LaHAYE, MD
LAFAYETTE, LA		 CDRH D 18-JUN-2002 Through hearing process
TIMOTHY A LAMPHIER, MD PALM SPRINGS, CA CDER D 14-FEB-1979 Through hearing process
ANTHONY LAPOLLA, MD CAMARILLO, CA CDER D 05-MAY-1969 Through hearing process
PETER K. LAW, Ph.D. Memphis, TN CBER D 23-OCT-2006 Through hearing process
HARVEY M LEVIN, MD PHILADELPHIA, PA CDER D 01-FEB-1980 Through hearing process
ROBERT A LEVINSON, MD NEWARK, NJ CDER D 31-MAR-1988 By consent agreement
ELLIN LIEBERMAN, MD SOUTH PASADENA, CA CBER D 12-OCT-1993 By consent agreement
DAVID NILS LOFGREN, MD SANDY, UT CBER D 28-APR-2008 By consent agreement
LEO LOWE, MD NEW YORK, NY CDER D 18-OCT-1966 Through hearing process
EUGENIA MARCUS, MD, NEWTON, MA
 CBER D 03-OCT-2004
 By consent agreement
ELBERT MCCRACKEN, MD STUTTGART, AR CBER D 03-MAY-1977 Through hearing process
JEFFREY L. McLEOD, MD MIDLOTHIAN, VA CDER D 29-SEP-2005 By Consent Agreement
GORDON MCHARDY, MD NEW ORLEANS, LA CDER DR 13-JUN-1968 (Reinstated 27-JAN-1969) Through hearing process
CHAVARAMPLAKIL P. MATHEW, MD, NEW ORLEANS, LA CDER D 24-Sep-2003 Through hearing process
KEITH M MINTON, DO TAMPA, FL CDER D 26-JAN-1993 By consent agreement
GEORGE MOSKOWITZ, MD CHARLESTOWN, SC CDER DR 31-JAN-1983 (Reinstated 31-JAN-1986) By consent agreement, for 3 years
ALLYN M. NORMAN, DO, GETZVILLE, NY CDER D 28-Oct-2002 By consent agreement
FELIPE P NOVO, MD TEWKSBURY, MA CDER D 04-NOV-1980 Through hearing process
JULIO A ORTIZ, MD HUMACAO, PR CDER D 03-DEC-1980 Through hearing process
ROY C. PAGE, MD
MEMPHIS, TN 		CBER D 04-APR-2003 By consent agreement
E A PAULK JR, MD ATLANTA, GA CDER D 08-JAN-1990 Through hearing process
BARRY R PAULL, MD BRYAN, TX CDER R 21-NOV-1991 Total
CHRISTOPHER M. PHILLIPS
North Port, FL 		CDER D 11-OCT-2006 By consent agreement
ROGER C POISSON, MD MONTREAL PQ, NG CDER D 28-MAY-1991 By consent agreement
CAREY L. QUARLES, PHD WELLINGTON, CO CVM D 29-JUL-2002 Through hearing process
LUTHER M REAGAN, PHD HEBRON, MD CVM D 01-NOV-1991 By consent agreement
ARNOLD RITTER, DO PHOENIX, AZ CDER D 28-FEB-1980 Through hearing process
KATHLEEN E ROBERTS, MD SAN FRANCISCO, CA CDER D 24-NOV-1964 Through hearing process
WILLIAM S ROBERTS, MD CHARLOTTE, NC CBER D 18-JUL-1991 By consent agreement
BENNETT ROBIN, MD SILVER SPRING, MD CDER D 19-JUN-1964 Through hearing process
C J ROSENTHAL, MD BROOKLYN, NY CDER D 21-JAN-1998 By consent agreement
STEPHEN D. ROSSNER, MD
WALLINGFORD, CT
 CDER
 D
 21-FEB-2008
 By consent agreement
STANLEY F ROTH MIAMI SHORES, FL CDER D 03-AUG-1982 By consent agreement
JEROME ROTSTEIN, MD BRONX,WHITE PLA, NY CDER D 03-DEC-1975 Through hearing process
NOEL M ROWAN, MD READING, PA CDER D 10-JUN-1985 By consent agreement
WALLACE RUBIN, MD NEW ORLEANS, LA CDER D 13-MAR-1970 Through hearing process
W M SAMS JR, MD BIRMINGHAM, AL CDER D 23-OCT-1997 By consent agreement
MANUEL SANGUILLY, MD TARRYTOWN, NY CDER D 23-NOV-1982 By consent agreement
FRANCOIS SAVERY, MD LONG BEACH, CA CDER D 06-OCT-1978 Through hearing process
MARY SAWAYA, MD OCALA, FL CDER D 08-SEP-2003 Plea agreement
JAMES J SCHEINER, MD FAIRFAX, VA CDER D 31-JUL-1979 Through hearing process
JEROME J SCHNEYER, MD SOUTHFIELD, MI CDER D 16-APR-1978 Through hearing process
DUANE SHERWIN, MD SEATTLE, WA CDER D 09-JUL-1982 By consent agreement
SHERIDAN W SHIRLEY, MD BIRMINGHAM, AL CDER R 30-JAN-1984 Total
PHYLLIS F SHROFF, MD PARADISE VALLEY, AZ CDER R 26-APR-1983 Total
HARRY SHUBIN, MD PHILADELPHIA, PA CDER D 16-MAR-1970 Through hearing process
LEONARD SLAZINSKI, MD SARASOTA, FL CBER D 28-AUG-1991 By consent agreement
LYMAN SMITH, MD ELGIN, IL CDER DR 17-MAR-1975 (Reinstated 08-JUN-1983) Through hearing process
RONALD C SMITH, MD LOS ANGELES, CA CDER D 01-AUG-1979 Through hearing process
JOSEPH H SOBATKA, MD PHOENIX, AZ CDER D 21-SEP-1970 Through hearing process
ALEXANDER S SPIERS, MD TAMPA, FL CDER DR 14-DEC-1987 (Reinstated 14-DEC-1990) By consent agreement, for 3 years
SAMUEL SPLITTER, MD HAMPSTEAD, NY CDER D 29-JUL-1968 Through hearing process
PETER P STEELE, MD DENVER, CO CDER D 02-APR-1986 Through hearing process
MARC J STRAUS, MD VALHALLA, NY CDER D 18-MAY-1982 By consent agreement
RICHARD A STREB, MD GONZALES, LA CDER D 03-JAN-1997 By consent agreement
DAVID O TABER, MD EL PASO, TX CDER R 17-JUN-1982 Total
STEVEN K TEPLICK, MD LITTLE ROCK, AR CDER D 08-MAR-1994 Through hearing process
ANAND TEWARI, MD NEW HAVEN, CT CBER D 18-NOV-1993 By consent agreement
MARIO P VALDEZ, MD TUCSON, AZ CDER R 03-FEB-1994 Total
JAMES C. VESTAL, MD
ARLINGTON, TX		 CDER D 05-MAY-2008 By consent agreement
HUIBERT M VRIESENDORP, MD MARSHFIELD, WI CBER D 31-DEC-2001 Through hearing process
WILLIAM T WALLENS, MD ROSWELL PARK, NY CDER D 22-AUG-1983 By consent agreement
JEROME WEISS, MD NEW YORK, NY CDER D 31-DEC-1984 By consent agreement.
JOSEPH L WILLIAMS LAS VEGAS, NV CDER DR 15-MAY-2003 Reinstated by correspondence
DAVID T WONG, MD WITCHITA, KS CDER R 09-JUL-1982 Total
ROBERT E YOUNG, MD COLUMBUS, OH CDER D 15-OCT-1982 By consent agreement
WILLIAM H. ZIERING, MD FRESNO, CA CDER D 11-JAN-2002 Plea agreement
 

List formatted 11/21/2001(tc)n=94; 1/15/2002(tc)n=108; added 4/2/2002(tc)n=109; added 06/27/2002 (tc)n=110; added 08/07/2002 (tc) n=111; added 10/16/2002 (tc) n=112; added 04/10/2003 (tc) n=113; added 10/17/2003 (tc) n=115; added 02/23/2004 (tc) n=116; added 10/13/2004 (tc) n=117; added 01/14/2005 (tc) n=118; added 11/02 & 14/2005 (tc) n=120; list revised 10/11/2006 (ca)n=121; list revised 10/23/2006 (ca)n=122