Horrified by FDA: He calls them horror stories.
David Anast, publisher of the Biomedical Market Newsletter in Costa Mesa, has decided to take on the U.S. Food and Drug Administration and its longstanding reputation for dragging its regulatory feet by launching a new column about the slowdown in medical device approvals.
Some analysts suggest that the slowdown in the FDA's approval process costs the industry millions of dollars every year and puts at risk some patients awaiting new medical treatments.
Anast said the "FDA Horror Stories" column is a long overdue forum to air frustrations about the time it takes for the FDA to give the nod for new products to be sold on the marketplace.
Because there was no earlier central forum for medical device executives to air their opinions, Anast said that news about the column has spread quickly.
"It has taken off like a rocket," Anast said. "We got calls from all over the world. It has really hit a raw nerve in the (medical device) community."