[Ip-health] FDA Staff Efforts To Issue Warning Letters On Procrit Ads Were Stopped By Counsel

[Joana Ramos]

 From 9 May 2008 issue of The Cancer Letter, full text available by
subscription only.

Joana


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http://www.cancerletter.com/tcl-blog/copy47_of_whats-going-on-with-nih


  FDA Staff Efforts To Issue Warning Letters On Procrit Ads Were Stopped
  By Counsel

 From The Cancer Letter, May 9, 2008:

Internal FDA documents
<http://www.cancerletter.com/publications/special-reports/FDA_ProcritDTC.pd=
f>
show that the agency made a series of unsuccessful attempts to stop a
direct-to-consumer advertising campaign that claimed that Johnson &
Johnson=92s erythropoiesis-stimulating agent Proctit (epoetin alfa)
improved =93fatigue=94 associated with chemotherapy-induced anemia.

The advertising campaign, which is widely credited with making ESAs into
the biggest-selling class of oncology drugs, was allowed to proceed with
relatively minor changes after the FDA Office of Chief Counsel became
involved in the controversy.

The details of the doomed effort by FDA staff to modify the Procrit
campaign emerged in the documents that were placed in the public record
at the May 8 hearing of the Subcommittee on Oversight and Investigation
of the House Committee on Energy and Commerce.

Click on The Cancer Letter Archive at left to download the May 9 issue
(subscription required).

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Joana Ramos, MSW
Cancer Resources & Advocacy
Seattle WA USA
+1-206-229-2420
http://ramoslink.info/
www.bmtbasics.org