The FDA requires that drugs be both safe and effective. It's the "effective" part that bothers some people. Effectiveness has to be established by clinical testing, which is expensive. Many new drugs fail, even after approval. The gold standard for "effective" is "after 10 years, are patients significantly better"?
The "natural"/"herbal"/"homeopathic" drug industry managed to get Congress to exempt them from the "effective" requirement. There was a big right-wing push for this. Rush Limbaugh had a financial stake in Zicam, which sells homeopathic cold remedies, and used to promote it on his radio show.
I'll give the FDA a lot of credit for things like blocking thalidomide from the US in the 1950s and 1960s (looks like Richardson-Merrell was pushing hard for US sales after it had already caused a disaster and been banned in Germany) http://en.wikipedia.org/wiki/Thalidomide . Like all things you have to balance the harm and good.
The FDA has a ton of power and resources. I would be highly surprised if they didn't have a large numbers of victories, but in relation to their power and resources it doesn't take much bias to find them lacking.
Even though they've stopped bad drugs, they've also stopped good ones. If you look at the net benefit of the FDA it's negative. Not that we shouldn't have any any drug approval process, just that the current one is too conservative.
The reason for the conservatism is simple. Everyone sees when bad drugs get through. It gets media attention, there are lawsuits, laws are proposed to retrospectively fix it, etc. But no one cares or even notices when a life saving drug is delayed or prevented from getting to those who need it.
And so there will always be extreme bias towards conservatism and we need to fight it.
Story time: I'm from Germany, co-founder of a company that builds lasers which are marketed toward users in biomedical research. So when selling into the USA we've to deal with the FDA twice: Because the application is medical and because these things are lasers (little known fact: The FDA also oversees laser safety regulations and enforcement).
In February I attended a conference in San Francisco and at the end of the week came down with benign infection; anyway I was headed to a pharmacy looking for some remedy; the first thing that had the label "FDA approved" on it I took. Why? Because I know firsthand how strict the FDA is and that they are a no-bullshit agency, so I knew that this thing surely was safe and be effective.
BTW: Getting a new medical device FDA approved is not a very time consuming process; at least not for diagnostic applications. It can be done in under half a year, if your paperwork is thorough and your testing solid.
The "natural"/"herbal"/"homeopathic" drug industry managed to get Congress to exempt them from the "effective" requirement. There was a big right-wing push for this. Rush Limbaugh had a financial stake in Zicam, which sells homeopathic cold remedies, and used to promote it on his radio show.