Implications of the Arcoxia rejection

A sign that the FDA may be changing philosophy:

The goal was once to continuously expand the pharmacopeia of available drugs, as long as each drug was safe. But, apparently, not anymore. In voting 20-1 to reject Arcoxia, FDA’s advisers said that for certain ailments, we have enough medicines. This will ultimately deny patients needed choices and it reflects a dangerous way of looking at drug development, safety, and, more importantly, the practice of medicine. Science is leading us toward matching specific drugs to specific patients, a therapeutic process that requires more drug variety, not less. The FDA may now be moving in the opposite direction.

Prev
Next