Less charitably: the FDA is intentionally slowing drug reviews as a bargaining tool.<p>It seems insane that drug approvals <i>could</i> be safely expedited by four months, at the suggested value to companies of $150-$300 MM, and this isn't done routinely. That revenue could easily pay for the extra eyeballs at FDA -- which are certainly much cheaper than the clinical trials themselves. I think if Congress were to question the FDA's workings, this could be prima facie evidence that the pace of drug reviews isn't set by hard constraints of public safety: it's slower than it could be, and agency leaders know it.
The FDA has probably caused more deaths in the past half century than all of the rest of the American state put together, wars and all, by slowing progress in medicine, making all sorts of avenues for research and development unprofitable, and making medicine that does exist far more expensive.<p>Regulators at the FDA are capricious and malign, and there are countless stories of petty revenge via increased demands for data and enormous imposed costs in time and money. This is the way things always go in the late stages of centralized, powerful bureaucracy with a side order of regulatory capture.<p>The only good thing I can find to say about the bureaucrats at the FDA is that they respond to regional regulatory arbitrage - to medical tourism - by loosening their grip and letting things through. Or at least they do when said treatments are so widely available elsewhere in the world that the risk of looking bad by continuing to block them in the US is worse than the risk of looking bad because one of the outcomes of a normal, low error rate in medicine gets picked up by the press. Look at simple stem cell transplants, now available in the US these last couple of years, for a good example of this in practice.
We'd probably be better off if every drug got a priority review. The FDA's incentives are warped: they get blamed for releasing a drug that causes harm, but receive little blame if a drug that would have prevented harm is delayed or not released.
Why don't we spend $10M to bolster the review team and clear the queue instead of creating $150M worth of perverted incentives that the companies will inevitably recoup from the health care system? Medicaid alone will probably pay more than it would take in salaries for qualified people to process applications.
Now this is the type of thing that's fun to see, I feel like this story's gonna be mentioned in the next freakonomics or Gladwell book. Good for the FDA, they should be congratulated for doing something good. And this is good.
Maybe they can create an incentive to create new antibiotics? I've heard there are few if any in the pipeline since they are not profitable to pharma companies and resistance is increasing alarmingly fast!
In other words, it's a lever that the FDA can (will they?) use to solve an important problem: the discrepancy between drugs that bring the greatest profit and drugs that bring the greatest societal benefit. Potentially a loss of efficiency in the strictest economic sense, but also potentially a very good thing in terms of benefit to society.