Industry says Vioxx verdict will fuel conservative approach
"There has been a shift back to more conservatism on two fronts," said Fred Hassan, Schering-Plough chairman and chief executive. "Companies have become more conservative about the types of products they are promoting in their pipelines . . . and the FDA is taking a closer look and that's slowing the rate of approval . . . There is much more discussion on each compound in development than there was two years ago."
Chris Viehbacher, president of GlaxoSmithKline's U.S. pharmaceuticals group, told The Journal, his company is already feeling the effects of a "conservative swing" at the FDA and the emphasis on risk avoidance has ripped through the company's research operations.
"You find the goalposts have shifted 10 years after you started developing a drug," Viehbacher told the newspaper.
Arthur Higgins, chairman of Bayer Healthcare said, "Developing drugs for primary care is becoming less attractive to the industry." Bayer has recently shifted its focus away from primary care to specialty areas like oncology.
Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs said in the newspaper report said that an emphasis on safety has always been a goal for the agency.
"Clearly the environment is more focused on drug-safety issues than in recent memory, but these issues were always front and center on the minds of FDA's review staff," Gottlieb said.