“Mr. Chairman, thank you and let me commend you and the staff on both sides of the aisle once again for the path-breaking work in this ImClone investigation.  There is so much more to this than people just following the news stories over the summer may realize. 

“Ultimately, this investigation comes down to doing what’s right for cancer patients. By exposing the problems that occurred with ImClone’s Erbitux and the FDA, you are helping to point the way for us to improve the drug-approval system – to make it work better for these and other patients desperately hoping for breakthrough treatments. 

“So with all the attention on insider trading and corporate governance – subjects we will take on today as they relate to the problems here -- the public should not forget that potential flaws in FDA’s drug approval process have been at the center of this investigation all along.  

“These flaws allowed a study of questionable quality to become the basis for fast-track application. They allowed irresponsible hyping of a promising drug as FDA silently stood by – thus raising and dashing hopes of thousands of cancer patients. 

“I am encouraged that since the June ImClone hearing, the FDA has reorganized pharmaceutical product reviews to enhance consistency and performance. This is a good first step and we are very interested to learn how FDA envisions this reorganization will improve the drug-approval system, especially for cancer drugs. I welcome Dr. Lester Crawford, FDA’s Deputy Commissioner, who can discuss this for us. 

“There’s clearly room for improvement. We know this from FDA’s own work. Consider Eloxatin. This colon-cancer drug was approved on an accelerated basis by FDA’s Center for Drugs on August 12, 2002, within 46 days of submission -- a new FDA record.  And it was approved based on an interim analysis of a Phase III randomized trial – a trial that measures actual patient survival -- instead of less reliable Phase II study-data on surrogate endpoints, which had been the basis for past accelerated-approvals and were the basis for ImClone’s application.

“Eloxatin shows a company can get accelerated approval just as fast as ImClone had hoped its drug would be approved, and with better data. Perhaps the Eloxatin case can be a useful model for the future. It clearly suggests that ImClone’s experience might have been different, if there had been better communication between FDA and ImClone. 

“I understand that FDA is working on a communications policy that is aimed at improving interactions between the agency and the companies it regulates.  This is encouraging and I am hopeful that FDA is moving in a constructive direction.  

“I look forward to hearing about FDA’s views on pre-market promotion or pre-market statements – a topic that also gets to ImClone’s actions and governance.  This aspect of the ImClone story is essential to our inquiry.  

“We now understand that ImClone directors and officers reaped millions from the sale of ImClone stock before FDA’s refusal-to-file letter. Cancer patients, of course, got their hopes dashed. And what did many ImClone shareholders get from the rejection of Erbitux? An 88% reduction in share price, delay in the development of Erbitux, a CEO – Sam Waksal -- who resigned and then was arrested and indicted. 

“ImClone Systems has now sued Sam Waksal because it believes he did not cooperate with the federal investigations while he affirmed to the company that he was cooperating.  

“Yet we have now learned that for years ImClone did not trust Sam Waksal with the company’s corporate credit card. It actually installed special procedures to ensure he did not charge the company for his personal expenses.  

“Why would ImClone management have trusted Dr. Waksal?  

“The media have already reported his financial problems, and his past firings for allegedly misleading and even falsified scientific work.  Fortune reports that, over the past 20 years, dozens of lawsuits and tax liens have been filed against Waksal by the IRS, New York State, American Express, banks and brokers, art galleries, contractors, and individuals.  

“Are we to believe that ImClone management was totally unaware of these issues?  Did the Board and management act properly in light of these red flags? We will be interested to hear from the ImClone witnesses on these questions and others surrounding the rejection of Erbitux. 

“Mr. Chairman, it is my hope that, from this investigation, we will see an improved drug-approval system -- where the public has confidence in the companies, the FDA and the companies are clearly communicating with each other, and drug-studies are conducted properly to provide information that will optimize the chances for approval, so patients can be helped.  

“Thank you, Mr. Chairman.”