Appropriate assessment of both benefits and risks critical in US regulatory process, says Lilly CEO

To sustain medical innovation, the US Food and Drug Administration must accelerate the adoption of a Benefit-Risk framework to inform decision-making in the regulatory process, said John Lechleiter, chairman, president and chief executive of US drug major Eli Lilly (NYSE: LLY).

In an address at the FDA News Fourth Annual Risk Management and Drug Safety Summit, Dr 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. The only way to make inroads against [chronic and other] diseases is to sustain the pace of medical progress," he warned.