" ! COMMITTEE PRINT 

112TH CONGRESS

1st Session 

S. PRT. 

112–20 

STAFF REPORT ON SANOFI’S STRATEGIC USE OF 

THIRD PARTIES TO INFLUENCE THE FDA 

PREPARED BY THE STAFF OF THE

COMMITTEE ON FINANCE 

UNITED STATES SENATE 

MAY 2011 

Printed for the use of the Committee on Finance 


congress.#13
STAFF REPORT ON SANOFI’S STRATEGIC USE OF THIRD PARTIES TO INFLUENCE THE FDA 

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1 

66–351 

" ! COMMITTEE PRINT 

112TH CONGRESS

1st Session 

S. PRT. 

2011

112–20 

STAFF REPORT ON SANOFI’S STRATEGIC USE OF 

THIRD PARTIES TO INFLUENCE THE FDA 

PREPARED BY THE STAFF OF THE

COMMITTEE ON FINANCE 

UNITED STATES SENATE 

MAY 2011 

Printed for the use of the Committee on Finance 


congress.#13
COMMITTEE ON FINANCE 

MAX BAUCUS, Montana, Chairman 

JOHN D. ROCKEFELLER IV, West Virginia 

KENT CONRAD, North Dakota 

JEFF BINGAMAN, New Mexico 

JOHN F. KERRY, Massachusetts 

RON WYDEN, Oregon 

CHARLES E. SCHUMER, New York 

DEBBIE STABENOW, Michigan 

MARIA CANTWELL, Washington 

BILL NELSON, Florida 

ROBERT MENENDEZ, New Jersey 

THOMAS R. CARPER, Delaware 

BENJAMIN L. CARDIN, Maryland 

ORRIN G. HATCH, Utah 

CHUCK GRASSLEY, Iowa 

OLYMPIA J. SNOWE, Maine 

JON KYL, Arizona 

MIKE CRAPO, Idaho 

PAT ROBERTS, Kansas 

MICHAEL B. ENZI, Wyoming 

JOHN CORNYN, Texas 

TOM COBURN, Oklahoma 

JOHN THUNE, South Dakota 

RICHARD BURR, North Carolina 

RUSSELL SULLIVAN, Staff Director 

CHRIS CAMPBELL, Republican Staff Director 

(II) 

C O N T E N T S 

Page 

Staff Report on Sanofi’s Strategic Use of Third Parties To Influence the 

FDA ....................................................................................................................... 1 

Appendix—Select Documents Cited in This Report .............................................. 5 

Exhibits Related to Footnote 1 ........................................................................ 6 

Exhibits Related to Footnote 2 ........................................................................ 10 

Exhibits Related to Footnotes 3, 4, and 8 ...................................................... 18 

Exhibits Related to Footnote 3 ........................................................................ 24 

Exhibits Related to Footnote 4 ........................................................................ 28 

Exhibits Related to Footnote 5 ........................................................................ 77 

Exhibits Related to Footnote 6 ........................................................................ 82 

Exhibits Related to Footnote 7 ........................................................................ 85 

Exhibits Related to Footnote 8 ........................................................................ 89 

Exhibits Related to Footnote 9 ........................................................................ 162 

Exhibits Related to Footnote 10 ...................................................................... 166 

Exhibits Related to Footnote 11 ...................................................................... 176 

(III) 

(1) 

1Letter to Sanofi CEO Greg Irace from Chairman Baucus and Ranking Member Grassley, August 11, 2010. 2 E-mail from Makovsky and Company Executive Vice President Gil Bashe to Sanofi Senior 

Director of U.S. Advocacy James Caro and Sanofi Associate Vice President of Employers and 

Quality Associations for U.S. Managed Markets Eric Racine, January 21, 2009, SA–SFC– 

0000330; Sanofi Power-point, Summary: Lovenox Patient Safety Strategy, January 2009, SA– 

SFC–0000331—SA–SFC–0000336. 3Payments from Sanofi to Dr. Victor Tapson from 2007 to August 11, 2010; e-mail from Sanofi 

Director of External Affairs Rachel Couchenour to Sanofi’s James Caro, July 7, 2008, SA–SFC– 

0000442; the Committee learned that Sanofi sponsored the March 2008 ACCP roundtable and 

Continued 

Staff Report on Sanofi’s Strategic Use of 

Third Parties To Influence the FDA 

A June 24, 2010 Wall Street Journal article reported that two 

medical groups and a doctor with financial ties to Sanofi submitted 

letters to the Food and Drug Administration (FDA) supporting 

Sanofi’s citizen petition requesting that the FDA delay approval of 

a generic version of the blood-thinner Lovenox. 

The Finance Committee requested records from Sanofi detailing 

its relationship with the North American Thrombosis Forum 

(NATF), the Society of Hospital Medicine (SHM), and Dr. Victor 

Tapson, based on a concern that there may have been a misuse or 

abuse of the citizen petition process.1

The documents obtained by the Committee suggest that NATF, 

SHM, and Dr. Tapson served as components of a coordinated public 

relations strategy by Sanofi to use FDA’s citizen petition process in 

an attempt to prevent or delay generic alternatives to its blockbuster drug Lovenox from coming on the market. 

A review of the documents provided by Sanofi revealed the following facts: 

• According to a 2009 Sanofi slide presentation on its ‘‘Lovenox 

Patient Safety Strategy,’’ a core issue faced by Sanofi was the 

‘‘imminent threat to [Sanofi’s] Lovenox franchise’’ posed by ‘‘generic alternatives.’’ The slides show that Sanofi sought to encourage ‘‘independent interaction with regulatory authorities.’’ 

Specifically, the ‘‘Progress To Date’’ slide identifies the ‘‘Independent communication with FDA by professional organizations and prominent [key opinion leaders]’’ regarding Lovenox.2

• Duke University medical professor Dr. Victor Tapson, who was 

paid $260,604 by Sanofi for ‘‘Speaker/Consultant Services,’’ 

wrote a May 21, 2008 letter from the American College of 

Chest Physicians to the FDA encouraging the agency ‘‘to learn 

more of the findings and recommendations’’ of a March 28, 

2008 ‘‘scientific interchange roundtable’’ in Huntington Beach, 

CA, which Sanofi paid $190,000 to sponsor.3

2 

a subsequent paid supplement in the ACCP newspaper for $190,000 during a telephone conversation between Committee staff and ACCP staff on February 8, 2011. 4Payments from Sanofi to SHM from 2007 to August 11, 2010; Society of Hospital Medicine, 

IRS Form 990s for fiscal year 2007 and fiscal year 2008. 5 ‘‘U.S. Communications & Public Affairs Major Activities Update for August, 2008’’, SA–SFC– 

0000191; e-mail from Sanofi’s Rachel Couchenour to Sanofi Associate Terri Yannotta, ‘‘Monthly 

Report—Action Item,’’ August 21, 2008, SA–SFC–0000270. 6 E-mail from Sanofi’s Rachel Couchenour to Sanofi’s Eric Racine, ‘‘RE: Timeline,’’ May 29, 

2008, SA–SFC–0000272; e-mail from Sanofi’s Rachel Couchenour to Senior Manager of SanofiAventis Groupe Mary Easterday and President of Pharmaceutical Strategic Initiatives Charles 

Carter, ‘‘SHM Meeting Follow-up,’’ May 16, 2008, SA–SFC–0000273. 7 E-mail from the CEO of the Society of Hospital Medicine Larry Wellikson to Sanofi’s Rachel 

Couchenour, ‘‘FW: LMWH Safety Letter,’’ June 27, 2008, SA–SFC–0000422. 8Payments from Sanofi to NATF from 2007 to August 11, 2010; North American Thrombosis 

Forum, IRS Form 990s for fiscal year 2007, fiscal year 2008 and fiscal year 2009. 9 E-mail from Sanofi’s James Caro to Sanofi’s Eric Racine, ‘‘NATF,’’ April 4, 2009, SA–SFC– 

0000308; e-mail from Sanofi’s James Caro to Sanofi Director of U.S. Policy and Strategic Advocacy John Agos, ‘‘Re: Status of Article From Nov. Roundtable,’’ May 6, 2009, SA–SFC–0000661. 

• SHM received $2,675,850 from Sanofi from January 2007 

through August 11, 2010 for conference exhibits, sponsorship, 

and grants. Sanofi’s payments to SHM totaled $1,132,500 between July 1, 2007 and June 30, 2009, accounting for 8 percent 

of SHM’s total revenue during those 2 years.4

• SHM’s August 2008 letter to the FDA stated that an ‘‘untested 

generic substitution for [low-molecular weight heparins] is not 

in our patients’ best interest.’’ Sanofi’s public relations team 

considered this letter to be a ‘‘key accomplishment.’’5

• Internal Sanofi communications indicate that SHM consulted 

with the American College of Chest Physicians and Dr. Tapson 

about sending a letter to the FDA after ‘‘a very positive meeting’’ with Sanofi officials.6

• Before sending the letter to the FDA, the CEO of SHM told 

Sanofi in an e-mail: ‘‘SHM has no history of making similar 

comments to the FDA or any government agency of this kind. 

While the Ec [Executive Committee] might be supportive they 

may feel this is not something that SHM has the expertise or 

knowledge to say much about. . . . That being said when something is important to any of our partners (like Sanofi) that we 

have a long term relationship with we want to give any issue 

that is important to our partner careful consideration.’’7

• NATF received $2,351,750 from Sanofi between January 2007 

and August 2010. From 2007 through 2009, Sanofi’s payments 

of over $2 million accounted for 81 percent of NATF’s total revenue during those 3 years.8

• After Sanofi officials met with NATF officials on ‘‘Lovenox and 

[follow-on-biologic] strategies,’’ Sanofi officials wrote about the 

need to ‘‘keep Vic and especially NATF on task for the FDA 

communication.’’9

• E-mails show Sanofi officials coordinated their media strategy 

with NATF and were sensitive to how Sanofi’s close relationship with NATF was perceived by the FDA and in the press. 

In one case, Sanofi officials decided against quoting a scientist 

affiliated with NATF in Sanofi’s press release on a generic 

version of Lovenox because they were concerned about NATF 

losing credibility with the FDA. In another case, Sanofi officials were concerned about how the press would perceive 

Sanofi’s relationship with NATF after a public relations firm 

3 

10 E-mail from Sanofi’s Noelle Boyd to James Caro and Eric Racine, ‘‘ISTH Quote in the press 

release,’’ January 26, 2010, SA–SFC–0000255; e-mail from Sanofi Associate Vice President for 

Lovenox Marketing Susan Barrett to Sanofi Senior Director of U.S. Communications Noelle 

Boyd, ‘‘ASH PR plan,’’ November 22, 2009, SA–SFC–0000265; Sanofi e-mails, ‘‘WSJ ad on 

Lovenox generic,’’ January 28, 2010, SA–SFC–0000256. 11 E-mail from Sanofi’s Eric Racine to Sanofi’s James Caro, ‘‘Grassroot and Orthopods and 

Canada,’’ July 22, 2009, SA–SFC–0000306. 

hired by Sanofi e-mailed a reporter to promote an NATF Wall 

Street Journal advertisement raising concerns about generic 

Lovenox.10

• According to Sanofi e-mails, Sanofi Senior Vice President and 

U.S. Chief Science Officer/Chief Medical Officer Paul Chew discussed ‘‘doing grassroot [sic] on [follow-on-biologics]’’ with associations. Vice President of Advocacy Eric Racine mentioned 

‘‘that some groups send 100–200 letters on a specific issue.’’11

(5) 

APPENDIX 

SELECT DOCUMENTS CITED IN THIS REPORT 

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Æ 


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