Issues Relating to the Safety of Accutane

Subcommittee on Oversight and Investigations
December 11, 2002
09:30 AM
2123 Rayburn House Office Building 

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Available Member Statements

There are no prepared Member Statements currently available.

Other Released Hearing Documents

Tab #	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 Graham suggesting that Accutane be withdrawn from the market immediately	May 7, 1990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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