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Inspections, Compliance, Enforcement, and Criminal Investigations

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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/ICECI/EnforcementActions/DisqualifiedRestricted AssuranceList/ucm2005409.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/ICECI/EnforcementActions/DisqualifiedRestricted AssuranceList/ucm2005408.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 ).
List revised: 01/08/2009 (Added: McGee).
List revised: 05/13/2009 (Added: Ericsson).
List revised: 07/02/2009 (Added: Miguel Zabalgoitia-Reyes).

List revised: 08/11/2009 (Added: Jeffrey N. Davidson, D.V.M. and Maurice Lippmann, M.D.)
List revised: 11/17/2009 (Added: Runels, Jr., Charles E., M.D. ).

 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
ABRUZZI JR, WILLIAM A., MD WAPPINGERS FALS, NY CDER D 31-AUG-1966 Through hearing process
 ACEVEDO, EDUARDO CARO, MD BAYAMON, PR CDER D 30-JUL-2002 Through hearing process
 ACHREJA, MANJEET KAUR, MD SEAGROVE, NC CDER D 24-APR-2008 By consent agreement

 AGUS, BERTRAND, MD

NEW YORK, NY

 CDER D 12-FEB-2008 By consent agreement

ALLBRITTON, ALLAN R.,

GONZALES, LA

 CVM D 24-JAN-1997 By consent agreement

ARONOW, WILBERT S., MD

OMAHA, NE

 CDER R 8-OCT-1982 Total

ALLEN, BRADY L., MD

DALLAS, TX

 CDER D 11-DEC-1990 By consent agreement
 ANDERSON, ROGER D., MD PITTSBURGH, PA CDER D 10-JAN-2005 By consent agreement
AROONSAKUL, CHAOVANEE, MD CHICAGO, IL CDER D 16-OCT-1991 Through hearing process

BALIN, HOWARD, MD

PHILADELPHIA, PA

 CDER D 19-MAR-1975 Through hearing process

BARATTA, VINCENT J., MD

N. LINDENHURST, NY

 CDER D 13-NOV-1985 Through hearing process

BENDER, SHELDON R., MD

PHILADELPHIA, PA

 CDER D 17-FEB-1969 Through hearing process

 BIGG, DANIEL

CHICAGO, IL

 CBER D 18-MAY-2007 By consent agreement.

BLUNCK JR, CARL E., MD

PLAQUEMINE, LA

 CDER D 07-JUL-1979 Through hearing process

BORISON, RICHARD L., MD

AUGUSTA, GA

 CDER D 10-NOV-1998 By consent agreement

BOWLING, CHETWYND E., MD

PHILADELPHIA, PA

 CDER D 13-NOV-1980 Through hearing process

BOYLES, PAUL W., MD

CARY, NC

 CDER D 13-APR-1995 Through hearing process

BRUSCHI, WALTER C., MD

LEAVENWORTH, KS

 CDER R 28-JUN-1983 Total

BUSHNELL, WALTER J., MD

DENVER, CO

 CDER D 16-SEP-1988 By consent agreement

 CAMPBELL, MARIA ANNE

KIRKMAN, MD, ALABAMA

 CDER D 8-MAY-2008 Total

CARTER, THOMAS N., MD

BETHESDA, MD

 CDER D 10-JUN-1980 By consent agreement

CARTER, CHARLES, MD

ORLANDO, FL

 CDER DR 31-AUG-1966 (Reinstated 29-JUL-1969) Through hearing process

CARUSO, WALTER A., MD

MT KISCO, NY

 CDER R 28- JUL-1988 Total

CASS, LEO, MD

CAMBRIDGE, MA

 CDER D 15-DEC-1965 Through hearing process

CATALDO, JOSEPH R., MD

ALEXANDRIA, VA

 CDER R 14-APR-1982 Total

CHAPLAN, ABRAHAM A., MD

ENGLEWOOD, NJ

 CDER D 28-FEB-1979 Through hearing process

CLOSE, JOHN H., MD

MIAMI, FL

 CDER D 19-JUL-1978 Through hearing process

COPELAN, HERBERT W., MD

PHILADELPHIA, PA

 CDER DR 19-JUL-1966 (Reinstated 19-AUG-1966) Through hearing process

CRANE, DANIEL L., MD

NEW YORK, NY

 CDER D 27-JUN-1984 By consent agreement

CULLEN, AUBREY P., MD

HOUSTON, TX

 CDER R 08-JUN-1987 Total

 DALEY, PATRICK J., MD

TULSA, OK

 CBER D 14-MAR-2008 Total

DALTON, FRED C., MD

MINEOLA, NY

 CDER D 03-JAN-1979 Through hearing process

DAVIDSON, JEFFREY N., DVM

TULARE, CA

 CVM D 20-JUL-2009 Through hearing process

DAY, PHILLIP L., MD

SAN ANTONIO, TX

 CDER D 28-AUG-1975 Through hearing process

 DeABATE, CARL ANDREW, MD

WASHINGTON, DC

 CDER D 05-FEB-2004 By consent agreement

DIAMOND, BRUCE I., PHD

AUGUSTA, GA

 CDER D 10-FEB-1999 By consent agreement

DOSS JR, WILLIAM L., MD

DETROIT, MI

 CDER D 14-JUN-1979 Through hearing process

DRESSLER, DAVID M., MD

NEW BRITAIN, CT

 CDER D 14-MAR-1984 By consent agreement

DUNLOP, EDWIN, MD

ATTLEBORO, MA

 CDER DR 16-FEB-1970 (Reinstated 24-DEC-1970) Through hearing process

 ERICSSON, ARTHUR DALE, MD

HOUSTON, TX

 CDER D 13-MAY-2009 By consent agreement
 FARBER, HAROLD F., MD NARBERTH, PA AND PHILADELPHIA, PA   D 18-JUL-2005 By plea agreement

FEURST, SAMUEL I., MD

VICKSBURG, MS

 CDER D 02-OCT-1984 By consent agreement

FIDDES, ROBERT A., MD

WHITTIER, CA

 CDER D 01-JUN-1999 Through hearing process

FOGARI, ROBERT, MD

JERSEY CITY, NJ

 CDER R 24-APR-1985 Total

FOX JR, ROBERT A., MD

BRANFORD, CT

 CDER D 15-FEB-1989 By consent agreement

FRANKLIN, WILLIAM C., MD

HOUSTON, TX

 CDER D 09-NOV-1982 By consent agreement

FRONING, EDWARD C., MD

SAN MATEO, CA

 CDER D 10-APR-1976 Through hearing process

FULLER, RONALD R.

NEWARK, OH

 CVM D 29-JAN-1988 Through hearing process

GAMARRA, MIGUEL H., MD 

CORAL GABLES, FL

 CDER D 31-MAY-1983 By consent agreement

GARETZ, FLOYD K., MD

MINNEAPOLIS, MN

 CDER D 23-NOV-1982 By consent agreement

GARFINKEL, BARRY D., MD

MINNEAPOLIS, MN

 CDER R 14-MAY-1994 Total

 GARJIAN, PEGGY ANN, MD

BROOKLYN , NY

 CDER D 22-SEPT-2008 By consent agreement

GATENBY, ROBERT A., MD

PHILADELPHIA, PA

 CDER D 15-NOV-1988 By consent agreement

 GENTRY, LAYNE O., MD

HOUSTON, TX

 CDER D 18-JUN-2008 Total

GILLESPIE, LARRIAN, MD

LOS ANGELES, CA

 CDER D 02-FEB-1989 By consent agreement

GOODING, JOHN M., DO

PANAMA CITY, FL

 CDER R 07-NOV-1986 Total

GRECU, EUGENE O., MD

SACRAMENTO, CA

 CDER D 25-MAR-1999 Through hearing process

GUERIN, BERNARD K., MD

RENO, NV

 CDER D 13-NOV-1984 By consent agreement

 GUY, MATTHEW J., MD,

ROCKAWAY PARK, NY

 CDER D 25-JUL-2008 By consent agreement

HALIKAS, JAMES A. 

MINNEAPOLIS, MN

 CDER D 15-JAN-2001 Through hearing process

 HOLLAND, JAMES A., MD

THOMASVILLE, GA

 CDER D 25-AUG-2008 Total
HOTCHKISS JR, DWIGHT J., MD FLEMINGTON, NJ CDER D 25-JUN-1984 Through hearing process

JOHN JR, J.T., MD

NASHVILLE, TN

 CDER D 04-NOV-1983 By consent agreement

 KAPNER, JAMIE, MD

 SCOTTSDALE, AZ

 CDER D 10-SEP-2007 By consent agreement

 KHOOBLALL, KHEM L., MD 

PARMA, OH

 CDER D 17-JUN-1998 By consent agreement

KLEBER, RONALD, MD

 MARIETTA, GA

 CDER D 06-AUG-1981 Through hearing process
KLIGMAN, ALBERT M., MD CONSHOHOCKEN, PA CDER DR 19-JUL-1966 (Reinstated 19-AUG-1966) Through hearing process

KLINE, NATHAN S., MD

 NEW YORK, NY

 CDER D 13-NOV-1980 Through hearing process

KNAPP, RICHARD B., MD

 MORGANTOWN, WV

 CDER D 04-NOV-1982 By consent agreement

KORNBLITH, PAUL., MD

 BRONX, NY

 CBER D 25-NOV-1991 By consent agreement
KOSTAS, CONSTANTINE I., MD LYNNFIELD, MA CDER D 07-OCT-1986 By consent agreement.

KURLAND, MORTON L., MD

 RANCHO MIRAGE, CA

 CDER D 06-NOV-1978 Through hearing process
LaHAYE, LEON C., MD
LAFAYETTE, LA		 CDRH D 18-JUN-2002 Through hearing process

LAMPHIER, TIMOTHY A., MD

 PALM SPRINGS, CA

 CDER D 14-FEB-1979 Through hearing process

LAPOLLA, ANTHONY, MD

 CAMARILLO, CA

 CDER D 05-MAY-1969 Through hearing process

 LAW, PETER K., PH.D.

 MEMPHIS, TN

 CBER D 23-OCT-2006 Through hearing process

LEVIN, HARVEY M., MD

 PHILADELPHIA, PA

 CDER D 01-FEB-1980 Through hearing process

LEVINSON, ROBERT A., MD

 NEWARK, NJ

 CDER D 31-MAR-1988 By consent agreement

 LIEBERMAN, ELLIN, MD

 SOUTH PASADENA, CA

 CBER D 12-OCT-1993 By consent agreement

LIPPMANN, MAURICE, MD

TORRANCE, CA

 CDER DR 30-MAY-1983 (Reinstated 05-NOV-1984) Through hearing process

 LOFGREN, DAVID NILS, MD

SANDY, UT

 CBER D 28-APR-2008 By consent agreement

LOWE, LEO, MD

NEW YORK, NY

 CDER D 18-OCT-1966 Through hearing process

 MARCUS, EUGENIA, MD

NEWTON, MA

 CBER D 03-OCT-2004
 By consent agreement

MCCRACKEN, ELBERT, MD

 STUTTGART, AR

 CBER D 03-MAY-1977 Through hearing process

 McGEE, J. MICHAEL, MD

 TULSA, OK

 CBER D 08-JAN-2009 Through hearing process

 McLEOD, JEFFREY L., MD

 MIDLOTHIAN, VA

 CDER D 29-SEP-2005 By Consent Agreement

MCHARDY, GORDON, MD

 NEW ORLEANS, LA

 CDER DR 13-JUN-1968 (Reinstated 27-JAN-1969) Through hearing process
 MATHEW, CHAVARAMPLAKIL P., MD NEW ORLEANS, LA CDER D 24-Sep-2003 Through hearing process

MINTON, KEITH M., DO

 TAMPA, FL

 CDER D 26-JAN-1993 By consent agreement
MOSKOWITZ, GEORGE, MD CHARLESTOWN, SC CDER DR 31-JAN-1983 (Reinstated 31-JAN-1986) By consent agreement, for 3 years

 NORMAN, ALLYN M., DO,

 GETZVILLE, NY

 CDER D 12-DEC-2002 By consent agreement

NOVO, FELIPE P., MD

 TEWKSBURY, MA

 CDER D 04-NOV-1980 Through hearing process

ORTIZ, JULIO A., MD 

HUMACAO, PR

 CDER D 03-DEC-1980 Through hearing process
 PAGE, ROY C., MD
MEMPHIS, TN		 CBER D 04-APR-2003 By consent agreement

PAULK JR, E.A., MD

 ATLANTA, GA

 CDER D 08-JAN-1990 Through hearing process

PAULL, BARRY R., MD 

BRYAN, TX

 CDER R 21-NOV-1991 Total
 PHILLIPS, CHRISTOPHER M.
NORTH PORT, FL		 CDER D 11-OCT-2006 By consent agreement

POISSON, ROGER C., MD

 MONTREAL PQ, NG

 CDER D 28-MAY-1991 By consent agreement

QUARLES, CAREY L., PHD

 WELLINGTON, CO

 CVM D 29-JUL-2002 Through hearing process
RAMIREZ-MELENDEZ, RAMON, MD TAMARAC, FL CDER D 25-NOV-2008 By consent agreement

REAGAN, LUTHER M., PHD

 HEBRON, MD

 CVM D 01-NOV-1991 By consent agreement

RITTER, ARNOLD, DO

 PHOENIX, AZ

 CDER D 28-FEB-1980 Through hearing process

ROBERTS, KATHLEEN E., MD

 SAN FRANCISCO, CA

 CDER D 24-NOV-1964 Through hearing process

 ROBERTS, WILLIAM S., MD

 CHARLOTTE, NC

 CBER D 18-JUL-1991 By consent agreement

ROBIN, BENNETT, MD

 SILVER SPRING, MD

 CDER D 19-JUN-1964 Through hearing process

ROSENTHAL, C.J., MD

 BROOKLYN, NY

 CDER D 21-JAN-1998 By consent agreement
 ROSSNER, STEPHEN D., MD
WALLINGFORD, CT		 CDER
 D
 21-FEB-2008
 By consent agreement

ROTH, STANLEY F., 

 MIAMI SHORES, FL

 CDER D 03-AUG-1982 By consent agreement

ROTSTEIN, JEROME, MD

 BRONX,WHITE PLA, NY

 CDER D 03-DEC-1975 Through hearing process

ROWAN, NOEL M., MD

 READING, PA

 CDER D 10-JUN-1985 By consent agreement

RUBIN, WALLACE, MD

 NEW ORLEANS, LA

 CDER D 13-MAR-1970 Through hearing process

 RUNELS, JR., CHARLES E., MD

MOBILE, AL

 CBER D 06-AUG-2009 Through hearing process

SAMS JR, W.M., MD

 BIRMINGHAM, AL

 CDER D 23-OCT-1997 By consent agreement

SANGUILLY, MANUEL, MD

 TARRYTOWN, NY

 CDER D 23-NOV-1982 By consent agreement

SAVERY, FRANCOIS, MD

 LONG BEACH, CA

 CDER D 06-OCT-1978 Through hearing process

 SAWAYA, MARY E., MD, PHD

 OCALA, FL

 CDER D 19-MAY-2004 By consent agreement

SCHEINER, JAMES J., MD

 FAIRFAX, VA

 CDER D 31-JUL-1979 Through hearing process

SCHNEYER, JEROME J., MD

 SOUTHFIELD, MI

 CDER D 16-APR-1978 Through hearing process

SHERWIN, DUANE, MD

 SEATTLE, WA

 CDER D 09-JUL-1982 By consent agreement
SHIRLEY, SHERIDAN W., MD BIRMINGHAM, AL CDER R 30-JAN-1984 Total

SHROFF, PHYLLIS F., MD

 PARADISE VALLEY, AZ

 CDER R 26-APR-1983 Total

SHUBIN, HARRY, MD

 PHILADELPHIA, PA

 CDER D 16-MAR-1970 Through hearing process

 SLAZINSKI, LEONARD, MD 

SARASOTA, FL

 CBER D 28-AUG-1991 By consent agreement

SMITH, LYMAN, MD

 ELGIN, IL

 CDER DR 17-MAR-1975 (Reinstated 08-JUN-1983) Through hearing process

SMITH, RONALD C., MD 

LOS ANGELES, CA

 CDER D 01-AUG-1979 Through hearing process

SOBATKA, JOSEPH H., MD

 PHOENIX, AZ

 CDER D 21-SEP-1970 Through hearing process

SPIERS, ALEXANDER S., MD

 TAMPA, FL

 CDER DR 14-DEC-1987 (Reinstated 14-DEC-1990) By consent agreement, for 3 years

SPLITTER, SAMUEL, MD

 HAMPSTEAD, NY

 CDER D 29-JUL-1968 Through hearing process

STEELE, PETER P., MD

 DENVER, CO

 CDER D 02-APR-1986 Through hearing process

STRAUS, MARC J., MD

 VALHALLA, NY

 CDER D 18-MAY-1982 By consent agreement

STREB, RICHARD A., MD

 GONZALES, LA

 CDER D 03-JAN-1997 By consent agreement

TABER, DAVID O., MD

 EL PASO, TX

 CDER R 17-JUN-1982 Total

TEPLICK, STEVEN K., MD

 LITTLE ROCK, AR

 CDER D 08-MAR-1994 Through hearing process

 TEWARI, ANAND, MD

 NEW HAVEN, CT

 CBER D 18-NOV-1993 By consent agreement

VALDEZ, MARIO P., MD

 TUCSON, AZ

 CDER R 03-FEB-1994 Total
 VESTAL, JAMES C., MD
ARLINGTON, TX		 CDER D 05-MAY-2008 By consent agreement
VRIESENDORP, HUIBERT M., MD MARSHFIELD, WI CBER D 31-DEC-2001 Through hearing process

WALLENS, WILLIAM T., MD

 ROSWELL PARK, NY

 CDER D 22-AUG-1983 By consent agreement

WEISS, JEROME, MD 

NEW YORK, NY

 CDER D 31-DEC-1984 By consent agreement.

WONG, DAVID T., MD

 WITCHITA, KS

 CDER R 09-JUL-1982 Total

YOUNG, ROBERT E., MD 

COLUMBUS, OH

 CDER D 15-OCT-1982 By consent agreement
 ZABALGOITIA-REYES, MIGUEL, MD SAN ANTONIO, TX CDER D 02-JUL-2009 By consent agreement

 ZIERING, WILLIAM H., MD

 FRESNO, CA

 CDER D 20-MAY-2008 Through hearing process
 

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
    
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