ImClone Crisis Management
Crisis Management
&
Corporate Communications
TABLE OF CONTENTS
EXECUTIVE SUMMARY 3 INTRODUCTION 4
BACKGROUND 5
PURPOSE AND SCOPE 5
ASSUMPTIONS 6
METHODS 6
COMPANY HISTORY 7
CRISIS ANALYSIS 7
RECOMMENDATION 9
a) External Communication 9
b) Internal Communication 10
REFERENCES 11
EXECUTIVE SUMMARY
ImClone Systems is a New York City based firm specializing in research and development of treatments and cures of cancer. The company’s Erbitux (C-255) product was not FDA approved as of the date of this occurrence, though it has been released for “compassionate Use” program under the FDA regulations. This enables the company to provide treatment to patients with terminally ill circumstances, who have not been included in the various clinical trials which are conducted by the company.
The patients request to receive this treatment and there is a general waiting list where applicants can notify the company of their interest to receive this treatment. The FDA does not require companies providing “compassionate use” programs to have or state their criteria for selection of candidates. ImClone, in complying with FDA requirements has procedures and standards for patients admitted to it s clinical trials, but has not established similar policies for its “Compassionate Use” program.
In 2001 the company faced some controversy when a patient who was rejected participation in the “compassionate use” program, was interviewed by CBS Television’s “60 Minutes” news program nationally in prime time. The woman was reported to have been rejected, while another woman who had also been rejected was later accepted, after reaching the company president directly. The implied bias painted a negative and profit oriented picture of ImClone.
Eight years later, our firm, Fortune Consultancy has reviewed the events and made recommendations
&
Corporate Communications
TABLE OF CONTENTS
EXECUTIVE SUMMARY 3 INTRODUCTION 4
BACKGROUND 5
PURPOSE AND SCOPE 5
ASSUMPTIONS 6
METHODS 6
COMPANY HISTORY 7
CRISIS ANALYSIS 7
RECOMMENDATION 9
a) External Communication 9
b) Internal Communication 10
REFERENCES 11
EXECUTIVE SUMMARY
ImClone Systems is a New York City based firm specializing in research and development of treatments and cures of cancer. The company’s Erbitux (C-255) product was not FDA approved as of the date of this occurrence, though it has been released for “compassionate Use” program under the FDA regulations. This enables the company to provide treatment to patients with terminally ill circumstances, who have not been included in the various clinical trials which are conducted by the company.
The patients request to receive this treatment and there is a general waiting list where applicants can notify the company of their interest to receive this treatment. The FDA does not require companies providing “compassionate use” programs to have or state their criteria for selection of candidates. ImClone, in complying with FDA requirements has procedures and standards for patients admitted to it s clinical trials, but has not established similar policies for its “Compassionate Use” program.
In 2001 the company faced some controversy when a patient who was rejected participation in the “compassionate use” program, was interviewed by CBS Television’s “60 Minutes” news program nationally in prime time. The woman was reported to have been rejected, while another woman who had also been rejected was later accepted, after reaching the company president directly. The implied bias painted a negative and profit oriented picture of ImClone.
Eight years later, our firm, Fortune Consultancy has reviewed the events and made recommendations
References: http://www.fda.gov/Fdac/features/2002/402_drug.html http://www.fda.gov/cder/about/history/default.htm http://web.archive.org/web/20050421114531/energycommerce.house.gov/107/hearings/06132002Hearing587/Papineau1014.htm#report http://www.cbsnews.com/stories/2001/05/03/60minutes/main289212.shtml http://www.fda.gov/cder/about/history/default.htm http://www.fda.gov/Fdac/features/2002/402_drug.html http://www.cbsnews.com/stories/2003/10/02/60minutes/main576328.shtml http://web.archive.org/web/20050421114531/energycommerce.house.gov/107/hearings/06132002Hearing587/Papineau1014.htm#report