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FDA Dangles Golden Ticket to Spur Drugs for Neglected Diseases
- barlescabbage 12y agoNow 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.
- revelation 12y agoWhy 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.
- JumpCrisscross 12y ago> 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? Because: 1. the $10 million would come out of the FDA's budget while the $150 million doesn't; and 2. spending $10 million to clear the queue would do nothing to incentivise drug development for neglected diseases, such as leishmaniasis.
- jonlucc 12y agoThese are both good points, but it is also important to note that it is not very easy to hire people to review drugs at the FDA. They have to be pretty aware of the state-of-the-art in their field in order to be able to effectively provide guidance to the drug companies.
- revelation 12y agoThe tremendous time and money requirement to navigate the FDA process for approval of a drug meanwhile does a lot to disincentivize the drug development for neglected diseases. It's biting its own tail.
- jmckib 12y agoWe'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.
- jonlucc 12y agoTo be fair, those kinds of stories usually play out in the financial news around drug companies, many of which have lobbyists and a team whose job it is to make sure they can get their drugs through.
- throwaway_yy2Di 12y agoLess charitably: the FDA is intentionally slowing drug reviews as a bargaining tool. It seems insane that drug approvals could 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.
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- htns 12y agoThis isn't the only fast track program the FDA has. While they might not be the most flexible organization, at least they are probably thinking in terms of risk/benefit to the public rather than in terms of safe/unsafe.
- powerset 12y agoIn 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.
- exratione 12y agoThe 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. 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. 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.
- djur 12y agoI appreciate people not being crippled or killed by poisonous patent medicines, myself. Or by untested procedures, or harmful implants and cosmetic surgeries, etc. It would be better if the FDA had more power over largely fraudulent markets like homeopathy, naturopathy, herbal medicine, etc. But for the time being those scams are largely unrestricted.
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- olva22 12y agoMaybe 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!
- refurb 12y agoThe GAIN Act was passed last year which provides incentives for new anti-infectives. The DISARM Act is another one being looked at that would make it easier for hospitals to use the latest and greatest antibiotics.
- olva22 12y agoAh! Good to hear they are legislating towards a bit more progress. Do you know if any pharma companies have re-entered antibiotic research since GAIN passed? I believe there's only a small handful of them left. Not to mention creating new drugs without implementing any rational controls over their use in humans and livestock is like pouring more gas on the fire. But I digress about leaving science to legislators....
- refurb 12y agoRoche just in-licensed a new compound to restart their antibiotic franchise. http://www.roche.com/media/media_releases/med-cor-2013-11-04.htm http://www.roche.com/media/media_releases/med-cor-2013-11-04...