Your new FDA commissioner wants new metrics. Dr. Margaret "Peggy" Hamburg (photo) wrote in a New England Journal of Medicine editorial that the agency's success shouldn't be measured by the number of drugs approved--or even the number of facilities inspected. It should be measured by its ability to promote public health. And that means the agency should use its regulatory powers more aggressively, she and her deputy commissioner Joshua Sharfstein (photo) maintain in the editorial published Tuesday.
It also means the world should view the agency less as a gatekeeper--or an ornery obstacle to new drugs and devices--and more as an enabler of health. That might cheer drugmakers at first glance, because the new FDA leaders agree that approvals can come too slowly, keeping sick folks from the innovative medications they need. But they also say that approving drugs too fast is just as bad, because it risks safety problems once the drugs hit the market.
"Key considerations are the severity of the illness at issue, the availability of alternative treatments or preventive interventions, and the current state of knowledge about individual responses," they write (as quoted by the Wall Street Journal Health Blog). Another issue, they said: The fact that drugmakers so often drop the ball on post-marketing studies. A company's drugs might get to patients more quickly if that company has been rigorous and prompt with study of products already on the market. Lots of food for thought.
- see the NEJM editorial
- read the story in the Wall Street Journal
- check out the Health Blog post