When Dr. Kessler was the Commissioner of the Food and Drug Administration from 1990-1997, approval times for new drugs were lengthy and people wanted faster approval times and easier access to new medicines. This was particularly true given the fact that the HIV epidemic had been going on for many years without effective treatments, leaving patients to try almost anything in desperation for some kind of treatment.
The result, as I've often written here, was a public policy change that put into place mechanisms for faster approval times on average, and even for accelerated approval where needed. The prevailing public sentiment did generate policy change.
In the 2000s however, there were a number of high profile drugs that experienced adverse event profiles that caused them to be withdrawn. The premium shifted from a focus on access to a more guarded sentiment that demanded greater safety. That, in turn, also has generated policy changes that have occurred and are still going on. We have become much more risk averse. How does that shift affect the approval of new drugs today, if at all?
I asked Dr. Kessler to comment on the shift in public sentiment and he had some interesting things to say.
