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Janet Woodcock M.D.
Director
Center for Drug Evaluation & Research
U.S. Food & Drug Administration
5600 Fishers Lane
Rockville, MD, 20857 |
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David Shove-Brown
210 11th Street, SE
Washington, DC, 20003 | Michael & Caroline Bencz
Represented by: Michael J. Ryan
Krupnick Campbell Malone Buser Slama Hancock McNelis Liberman & McKee, P.A
700 Southeast Third Ave., Ste. 100
Fort Lauderdale, FL, 33316-1186 | Susan Turney
Represented by: David P. Affinito
Dell'italia, Affinito & Santola
18 Tony Galento Plaza
Orange, NJ, 07050 | Debra Wallace
3207 Buckeye Run
Fort Wayne, IN, 46814-8905 | Nancy S. Green M.D
Medical Director
March of Dimes
1146 19th St. NWS
Suite 600
Washington, DC, 20036 | Lynn Martinez
Manager of Teratology and Birth Defects Program
Organization of Teratology Information Services
Utah Department of Health
P.O. Box 144691
Salt Lake City, UT, 84114-4691 | Diane S. Berson M.D.
Assistant Professor of Dermatology
Joan and Sanford I. Weill Medical College
Cornell University
425 E. 42nd Street
New York, NY, 10021 |
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George B. Abercrombie
President & Chief Executive Officer
Hoffmann-La Roche Inc.
340 Kingsland Street
Nutley, NJ, 07110
Accompanied By:
William Levi Smith, Ph.D.
Director
Medical ScienceHoffman-La Roche Inc
Susan P. Ackerman, Ph.D.
Global Head
Risk Management
DirectorMedical Outcomes Research, Economics, & Epidemiology DepartmentHoffman-La Roche Inc. |
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#
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Description
of Document
|
Date
|
| 1 |
Internal
Roche Research report |
January
13, 1982 |
| 2 |
Lammer’s
memo quoting Roche that they will encourage abortion |
July
29, 1983 |
| 3 |
Letter
from Dr. Oakley recommending Accutane be removed from market |
February
1, 1988 |
| 4 |
Letter
from Dr. Erickson discussing Accutane and Etretinate |
March
17, 1988 |
| 5 |
Memo
from Dr. Graham on design considerations for Accutane post-marketing
studies |
July
1, 1988 |
| 6 |
Dear
Doctor letter from Roche on changes in product information |
September
1988 |
| 7 |
Letter
from James Schlesselman saying Accutane Survey not worth doing unless
changed |
October
14, 1988 |
| 8 |
Memo
by Dr. Graham questioning the wording of Roche’s Dear Doctor letter and
saying it implies 100% teratogenicity |
October
20, 1988 |
| 9 |
Letter
from Dr. Hulka about Accutane Survey |
October
28, 1988 |
| 10 |
Memo
by Dr. Graham on Roche proposed post-marketing studies |
April
6, 1989 |
| 11 |
Article
from Dermatology Nursing on Accutane |
October
1989 |
| 12 |
Memo
by Dr. Graham suggesting that Accutane be withdrawn from the market
immediately |
May
7, 1990 |
| 13 |
Memo
from Bob Nelson stating that Roche product labeling implies 100% birth
defect rate |
February
19, 1991 |
| 14 |
Fax
from Roche to Bob Nelson with attached tables |
April
3, 1991 |
| 15 |
Article
from Columbus Dispatch quoting Dr. Graham’s memo |
July
14, 1996 |
| 16 |
Memo
from Dr. O’Connell to Dr. Wilkin about suggested addition of depression
to box warning |
May
1, 1997 |
| 17 |
Quote
from FDA memo by Dr. O’Connell |
February
1998 |
| 18 |
Memo
from Goetsch and Vega on Fatal Suicide Reports |
February
23, 1998 |
| 19 |
Warning
Letter to Roche on misleading advertising |
March
5, 1998 |
| 20 |
Accutane
Quarterly Report numbers on adverse events |
March
2000 |
| 21 |
Series
of letters from Roche to FDA about Internet sales of Accutane and related
materials |
April
4, 2000-December 10, 2002 |
| 22 |
Email
from Wilkin discussing issues for upcoming Advisory Committee meeting |
June
20, 2000 |
| 23 |
Emails
and letter about difference between FDA adverse event numbers and
Roche’s numbers |
August
29, 2000 |
| 24 |
Woodcock’s
letter reflecting advisory committee recommendations |
October
6, 2000 |
| 25 |
Emails
about Lotronex and Accutane issues |
November
30, 2000 |
| 26 |
Letter
from Roche to Mr. Stupak |
April
4, 2001 |
| 27 |
Editorial
from Teratologists in JAMA |
April
4, 2001 |
| 28 |
Teratology
article about continued occurrence of Accutane-exposed pregnancies |
May
7, 2001 |
| 29 |
Email
from Woodcock on Slone survey |
May
20, 2001 |
| 30 |
Email
from Ann Trontell on Slone survey |
May
24, 2001 |
| 31 |
Email
from Pitts saying Accutane’s teratogenicity is equal to that of
thalidomide |
July
16, 2001 |
| 32 |
Email
from Beitz estimating that the number of congenital anomalies in
Accutane-exposed pregnancies is between 12 and 42% |
July
27, 2001 |
| 33 |
Draft
of O’Connell memo entitled “Accutane and Psychiatric Adverse Events:
The FDA Perspective” |
August
1, 2001 |
| 34 |
O’Connell
and Bull’s responses to email from a dermatologist suggesting FDA has
anti-abortion agenda |
August
3, 2001 |
| 35 |
Email
from Trontell stating that 3% of Accutane prescribers write 20% of
Accutane scripts |
August
31, 2001 |
| 36 |
Roche
email celebrating the fact that have no registry which would have
alienated AAD |
October
30, 2001 |
| 37 |
Letter
from Waugh to FDA with accompanying internal report “General
pharmacological and drug interaction studies...” |
January
30, 2002 |
| 38 |
Journal
of Amer. Acad. Of Derm. article by Wysowski |
April
2002 |
| 39 |
Email
string discussing underreporting of adverse events “1 in 100” |
April
9, 2002 |
| 40 |
Elle
magazine article--Accutane |
October
2002 |
| 41 |
Article
about Roche marketing representative who violated marketing rules |
November
29, 2002 |
| 42 |
Stupak
letter to Woodcock |
December
6, 2002 |
| 43 |
Summary
of Advisory Committee meetings 1988-90 |
No
date |
| 44 |
“The
Dead, the Deaf, and the Dizzy” |
No
date |
| 45 |
Memorandum
of Teleconferences between Roche and FDA |
No
date |
| 46 |
Letter
from FDA to Roche about representative making misleading statements about
Accutane at exhibit booth |
No
date |
| 47 |
Series
of Roche slides |
No
date |
| 48 |
Graham
memo discussing fact that HHS should withdraw Accutane from market |
No
date |
| 49 |
Table
of Accutane Distribution Data |
No
date |
| 50 |
Roche
Dear Doctor letter on changes |
No
date |
| 51 |
Chart
on numbers of exposed pregnancies |
No
date |
| 52 |
Table
on Accutane Survey numbers, post-SMART |
2002 |
| 53 |
Acne
Free Advertisement |
No
date |
| 54 |
Chart
of Top 25 Territories |
No
date |
| 55 |
Roche
2001 Strategic Plan for Accutane |
2000 |
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