Chronology of Prasugrel Controversy 16

Prasugrel Chronology

January 30

FDA releases briefing documents and committee roster

The FDA incompletely scrubbed redacted text from its briefing document

February 2

The FDA rescrubs the briefing document. The original document is still available on CardioBrief.

Sanjay Kaul removed from FDA advisory panel

The Wall Street Journal Health Blog: Prasugrel Review Proceeds Without Key Safety Experts

February 3

FDA advisory panel recommends approval of prasugrel

Complete coverage of advisory hearing in heartwire

February 4

Victor Serebruany criticizes FDA hearing

February 9

CardioBrief Editorial: the incompetence of the FDA

February 11

Inside Indiana Business writes about the post-meeting discussions between Lilly and FDA

FDA provides “explanation” for Sanjay Kaul’s absence

February 13

Heartwire story provides most detailed account yet of prasugrel hearing

http://cardiobrief.org/2009/02/13/heartwire-story-provides-most-detailed-account-yet-of-prasugrel-hearing/

February 19

FDA offers more detailed explnation for Kaul’s absence on prasugrel committee

http://cardiobrief.org/2009/02/19/the-uninvited-part-2-fda-offers-more-detailed-explanation-for-kauls-absence-on-prasugrel-committee/

February 20

Heartwire: “Mistakes” made: FDA acknowledges Lilly phoned to question Sanjay Kaul’s inclusion on prasugrel panel


February 23

Wall Street Journal: Prasugrel gains European approval

CardioBrief: Prasugrel gains European approval



February 24-25 Lilly contact to FDA widely reported in the mainstream press and the blogosphere:

http://online.wsj.com/article/SB123544421394356087.html

http://www.gooznews.com/archives/001337.html

http://www.bloomberg.com/apps/news?pid=20601103&sid=aip8p9P.dMzg&refer=us

http://industry.bnet.com/pharma/10001124/fdas-prasugrel-machinations-seem-bound-to-attract-doubt/

http://blogs.nature.com/news/thegreatbeyond/2009/02/fda_flawed_drug_approvals.html

http://www.google.com/hostednews/ap/article/ALeqM5iwzSX1pVX04JRgRFPvBTyT2jGPbQD96I3PJO6

CardioBrief Transcript of FDA February 23 News Conference on prasugrel advisory panel

February 26

Reuters article by Susan Heavey reports 2 congressional inquiries

February 28 – March 3

Indianapolis Star reports prasugrel may be delayed due to congressional inquiry

Cowen & Co analysts downgrade Lilly on a clouded view for prasugrel

New York Times summarizes the prasugrel situation

CardioBrief comments on the possible prasugrel delay

March 10

FDA posts transcript and minutes of prasugrel advisory committee meeting

April 8

Prasugrel makes worldwide debut in United Kingdom

May 5

Prasugrel not affected by common CYP genetic variations

June 3

Serebruany and Wolfe ask FDA to halt review of prasugrel

June 9

UK’s NICE favors restricted approval for prasugrel

June 12

What do FDA insiders really think of prasugrel?

Lilly responds to Serebruany attack on TRITON-TIMI 38

June 19

FDA official defends integrity of prasugrel review

July 10

Congressman: FDA admits Kaul should not have been dismissed from prasugrel panel

FDA approves prasugrel!

July 14, 2009

Prasugrel approval aftermath: now the real battle begins

July 15, 2009

Deepak Bhatt editorial in NEJM:Prasugrel in Clinical Practice.

NEJM: Bhatt editorial evaluates prasugrel in clinical practice (CardioBrief story)

Lilly To Price Effient 18% Higher Than Plavix In US (Dow Jones newswire story by Peter Loftus)

Prasugrel priced 18% more than clopidogrel in US by Lilly/Daiichi Sankyo (CardioBrief)

July 31, 2009

The In Vivo Blog: The Effient Launch: Cracking the Door to Primary-Care Marketing

August 5, 2009

Prasugrel finally hits the street

August 10, 2009

30 days after prasugrel approval FDA releases some briefing documents. (You can access all the FDA documents by clicking on this link and searching for “prasugrel.” Or you can click on this link, which links to most of the same documents but does not include links to the Medication Guide or the REMS (Risk Evaluation and Mitigation Strategy) document.

“This has not been a well managed review process” –FDA official on prasugrel approval (CardioBrief, August 11)

September 2, 2009

FDA official reviews his own prasugrel review in NEJM

September 11, 2009

Reuters story by Brendan Borrell on prasugrel ghostwriter

CardioBrief: Editor insists prasugrel ghostwriter go public

Scott Hensley’s article in the NPR Health blog.

September 21, 2009

Wall Street analyst calls prasugrel launch “muted”

October 5, 2009

FDA posts full drug approval package for prasugrel

October 20, 2009

Medco launches 14,000 patient head-to-head comparison of clopidogrel and prasugrel

October 28, 2009

UK’s NICE allows limited use of prasugrel

Click here to read a PharmaTimes story by Selina McKee.

Click here for the NICE page with links to the guidance documents.

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16 comments

  1. Pingback: Flap over prasugrel advisory committee leads to 2 congressional inquiries « CardioBrief

  2. Pingback: Comment: If prasugrel is delayed, who is to blame? « CardioBrief

  3. Pingback: FDA posts transcript and minutes of controversial prasugrel hearing « CardioBrief

  4. Pingback: Prasugrel makes worldwide debut in United Kingdom « CardioBrief

  5. Pingback: Two radically different approaches to financial incentives « CardioBrief

  6. Pingback: Serebruany and Wolfe ask FDA to halt review of prasugrel « CardioBrief

  7. Pingback: UK’s NICE favors restricted approval for prasugrel « CardioBrief

  8. Pingback: What do FDA insiders really think of prasugrel? « CardioBrief

  9. Pingback: FDA official defends integrity of prasugrel review « CardioBrief

  10. Pingback: FDA approves prasugrel! « CardioBrief

  11. Pingback: FDA official on prasugrel approval: “This has not been a well managed review process.” « CardioBrief

  12. Pingback: FDA official reviews his own prasugrel review in NEJM « CardioBrief

  13. Pingback: Editor insists prasugrel ghostwriter go public « CardioBrief

  14. Pingback: FDA posts full drug approval package for prasugrel « CardioBrief

  15. Pingback: Medco launches 14,000 patient head-to-head observational comparison of clopidogrel and prasugrel « CardioBrief

  16. Pingback: Lilly reports modest sales figures for Effient (prasugrel) « CardioBrief

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