The president is serious about dismantling the FDA to usher in more medical "miracles." That’s wrong. - From Vox
The FDA is now the fastest drug regulatory agency in the world.
But the more important question is whether expedited FDA pathways increased the number of innovative new therapeutic options for patients — and here the data is far less clear.
For example, several studies have found that since the mid-1990s, about 85 to 90 percent of new drugs that have come onto the market don't offer any clinical advantages for patients compared with existing therapies.
Newer research, led by Kesselheim in the BMJ, looked at a database of all new medicines approved by the FDA between 1987 and 2013 and found that over the past two decades, the proportion of new drugs qualifying for at least one of the FDA's expedited programs has increased by 2.4 percent per year.
And shortly after the vaccine’s introduction, problems with its production resulted in the Cutter Incident: Vaccines with live polio virus (instead of killed virus) were administered to thousands of American children, sickening 40,000, leaving 200 paralyzed, and killing 10.