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Lilly CEO Says Appropriate Assessment of Both Benefits and Risks Critical in Regulatory Process
Date:11/2/2011

WASHINGTON, Nov. 2, 2011 /PRNewswire/ -- To sustain medical innovation, the FDA must accelerate the adoption of a Benefit-Risk framework to inform decision-making in the regulatory process, said John Lechleiter, Ph.D., chairman, president and CEO of Eli Lilly and Company (NYSE: LLY).  

In an address at the FDA News Fourth Annual Risk Management and Drug Safety Summit, Lechleiter called for a regulatory process that focuses both on recognizing and appreciating benefits while identifying and minimizing risks. Such a balanced approach would help increase the flow of needed medicines to patients and reverse a trend of fewer new drugs getting approved, he said.

"The stakes are high," Lechleiter said. "The only way to make inroads against [chronic and other] diseases is to sustain the pace of medical progress."

The upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA) V provides an important platform to address these issues. PDUFA, first enacted in 1992, sets the foundation for how FDA will manage the drug review process for five years, beginning in October 2012.

Lechleiter stressed the importance of a non-partisan course for reauthorization. "As a basis for the drug review process, PDUFA is too important to get bogged down in partisan politics," Lechleiter said. "As Congress considers reauthorization next year, we hope to see a 'clean' bill – one free of extraneous and controversial provisions that would politicize the bill and further complicate matters for all parties."


Even after PDUFA V, Lechleiter said the regulatory system must continue to evolve to meet 21st century needs.  He outlined five characteristics of a "state of the art" regulatory approval system:

  • Timely – "There are far too many conditions for which therapy is inadequate or nonexistent.  We need a system that is not only effective, but efficient as well."

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SOURCE Eli Lilly and Company
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