So, a few points (I didn't downvote you).

1) First, FDA fast-tracks many bad things. Hundreds of millions of people were irradiated by scanners that FDA waved on through because a fellow .gov agency (TSA) sponsored them. So: even the risk-averse can't trust a single centralized regulator to be "risk-averse" rather than "pro-government". We need multiple regulators (see my posts elsewhere in the thread), where you can use things approved by the slower/expensive/safest one while I can use items approved by the faster/cheaper/riskier ones.

http://arstechnica.com/science/2010/11/fda-sidesteps-safety-...

Dr. Holdren passed the letter on to the Food and Drug
Administration for review. But, in the FDA's response, the
agency gave the issues little more than a data-driven brush
off. They cite five studies in response to the professors'
request for independent verification of the safety of these
X-rays; however, three are more than a decade old, and none
of them deal specifically with the low-energy X-rays the
professors are concerned about. The letter also doesn't
mention the FDA's own classification of X-rays as
carcinogens in 2005.

2) Second, the formal IND fast-track program you mention is very political to get into (on the device side there's something similar called Pathway to Innovation). Moreover, FDA doesn't count days like you and I count days. It's like an NFL game which is 60 minutes but actually takes three hours; every time they email you back, it stops their clock. And they can email you back to ask for data that takes months to gather. This is from a device consultant but the principle is the same for drugs:

http://www.myraqa.com/blog/how_long_is_90_days

By law, FDA must respond to your 510(k) within 90 days, and
typically they do. The thing you have to understand is that
FDA measures 90 days about the same way the NFL measures
the 60 minutes in a football game. It's not unusual for the
clock to spend more time stopped than running.

3) Third, regarding thalidomide, as you probably know there were three major catastrophes that increased FDA power (1906 publication of the Jungle which birthed proto-FDA, 1938 elixir of sulfalinamide, and 1962 thalidomide) and another major catastrophe in the early 90s that reduced FDA power (FDA delays on AZT and slowdown of AIDS drugs).

Thalidomide in particular is to the FDA what 9/11 is to the TSA, it's the justification for everything they do. If you get into the history books you'll see that Frances Kelsey never actually suspected teratogenic effects; she suspected neurological issues. Moreover, thalidomide was actually a very efficacious drug for morning sickness, it was just unsafe. Yet the 1962 revision to the FD&C act added efficacy testing on top of safety testing.

That's weird. The thing is, toxicological/safety testing, even aggressive safety testing is "only" in the tens of millions, not billions. It's efficacy testing (and then comparative effectiveness) that really piles on the dollars. If the lesson of thalidomide was that we should do aggressive safety testing, then no one got the message, because Kefauver & Harris' 1962 amendments to FD&C meant we ended up spending several hundred billion dollars on efficacy instead.

Perhaps then the lesson from thalidomide might be that pregnant mothers should be much more risk-averse in what drugs they take. It's not really a lesson that says "we need to delay all drugs more", because due to pharmacogenomics some side effects are only going to be apparent when you introduce them into humans on a large scale anyway.

Moreover, risk can't be eliminated, and different people will have different risk profiles. What if a 70 year old man with terminal cancer wants to take an experimental, non-FDA approved drug? Do you sue like the FDA did in Cowan vs. US to prevent him from doing so?

For that matter, what if a 25 year old pregnant woman wants to take a new drug? Do we prevent her from doing so? Maybe we should, but we currently don't stop pregnant women from drinking alcohol or smoking cigarettes.

One has to think very carefully about whether every tragedy means one must ban or mandate something with a federal law.