The New York Times reports, “Government officials, drug companies and medical experts, faced with outbreaks of antibiotic-resistant “superbugs,” are pushing to speed up the approval of new antibiotics, a move that is raising safety concerns among some critics.”
But the only “critics” the Gray Lady was able to unearth were a former mid-level FDA reviewer and old reliable agency critic Steve Nissen.
Critic #1: “There is really no way of knowing how these drugs are going to perform,” said Dr. John H. Powers, a former F.D.A. antibiotics reviewer who is now an associate professor at George Washington University in Washington.
That is clearly not correct. These “special medical use” products aren’t going direct from bench to bedside – they must still undergo rigorous, FDA-approved development programs -- albeit carefully monitored trunicated ones with robust Phase IV follow-up.
Critic #2: “The big problem is controlling the marketing,” said Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic and a frequent critic of the F.D.A. “Companies can get a drug on the market for a narrow indication and before you know it, it is being used in everybody.”
This is a recording.
Now on to the real issue – a huge and global public health crisis.
“We are facing a huge crisis worldwide not having an antibiotics pipeline,” said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the Food and Drug Administration. “It is bad now, and the infectious disease docs are frantic. But what is worse is the thought of where we will be five to 10 years from now.”
The compete New York Times article can be found here.
