Comment Re:FDA-as-disease-process (Score 1) 140
DES was approved by the FDA, so clearly the FDA was not helpful in preventing the drug from reaching the market.
Thalidomide was not approved by the FDA primarily due to bureaucratic delay. While the FDA doctors would not approve it as they were waiting for evidence it was safe and effective, they would have approved it eventually were it not for the birth defects that starting showing up in other countries. Drug testing protocols simply did not test pregnant women. I.e., the US was largely spared thalidomide babies because the approval process was slower than in other countries as there was nothing in the testing to date that would have prevented approval.
When you read a headline that FDA approves new drug able to prevent 10,000 deaths annually, rest assure this also means the FDA has been blocking a drug that would have prevented 10,000 annually, most likely for quite a few years.
The drug companies have considerable incentive to market new and expensive (non-generic) drugs. But the expense to bring new drugs to market is also very high, at least in part due to FDA rules. The very high costs tend to kill-off promising developments that would simply not be economical to develop. Real life can be a bit complicated.