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Low-hanging fruit at the FDA

Perhaps the simplest way to lower costs, speed innovation and even improve health would be to give the FDA the funding it needs to evaluate new treatments and drugs more quickly.

Five years ago, the FDA typically approved a new generic drug within 16.3 months of the application’s filing, according to a report from the agency on Tuesday. But by last year, with limited staff to review an increasing number of applications, approvals for new generic drugs were taking 26.7 months, the report said.

There is no doubt that plenty of generic drugs have reached the market, as they now account for more than 70 percent of prescriptions filled in the United States. The generics industry has saved consumers nearly $750 billion over the last decade, Dr. Hamburg said at the conference.

But the number of applications for new generic drugs is far outstripping the agency’s capacity to review them, she said. As a result, the agency now has a backlog of nearly 2,000 pending generic applications — more than double the backlog in 2005.

There are things we could do to improve the health-care system that will be very hard. And then there are things we can do that will be very easy. This is one of those easy things.

By Ezra Klein  |  February 22, 2010; 1:34 PM ET
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I agree 1000%. Stand up to Pharma too while you're at it instead of making deals with them thinking they're not the problem.

Remember this little tidbit from November?

If Tom Toles was around them I'm sure we'd see a picture of Obama shaking hands with Billy Tauzin (with a pinnochio style nose)while Tauzin said "Sure we'll reduce our prices, whatever you say!" all while his other hand was in Obama's pocket.

Posted by: visionbrkr | February 22, 2010 2:03 PM | Report abuse

Ok, but then what funding can be increased to reduce the back-log of other important things. Some of those things might include disability applications, visa applications etc.

Posted by: ideallydc | February 22, 2010 2:04 PM | Report abuse

Allowing America to collectively bargain with Pharma, like every other industrialized country in the world already does, wouldn't cost America a thing. In fact, it would save us huge sums of money.

Politically it will be difficult, though, because Pharma owns so very many of our politicians.

I want to get the same break everybody else in the world gets. Pharma insists it needs to be profitable, I agree. Since Pharma sells all over the world shouldn't its profits be coming from all over the world?

Posted by: nisleib | February 22, 2010 2:10 PM | Report abuse

*Stand up to Pharma too while you're at it instead of making deals with them thinking they're not the problem.*

Getting Pharma on board with Medicare Part D and HCR was like getting doctors on board with Medicare in the 60s. You guarantee them private-market-rate compensation in the beginning to get them on board. As the years go on, they become dependent on the government programs to cover their income (many doctors simply wouldn't have patients were it not for Medicare, because those patients would have died), and then the government will have enough leverage to negotiate prices down.

But shoving generics through the approval pipeline faster is the biggest priority. Off-patent drugs are the right of the public in exchange for having given monopoly power to the drug companies for 17 years. It's money straight out of the pockets of the public if we don't get those generics approved.

Posted by: constans | February 22, 2010 2:22 PM | Report abuse

Well, technically, more money to approve generics is not the same as more money to "evaluate new treatments and drugs more quickly." Generics are just copies of existing drugs. But it's true that quicker generic approvals would probably lower costs.

As the NYT story notes, the FDA reviews new drugs on a set schedule because the drug companies pay for most of the review costs. There's no such fee for generics, though the FDA has been asking for one for years.

Posted by: NobodySpecial3 | February 22, 2010 2:26 PM | Report abuse

--"Perhaps the simplest way to lower costs, speed innovation and even improve health would be to [GET RID OF] the FDA"--

There. I fixed it.

Posted by: msoja | February 22, 2010 2:45 PM | Report abuse

Absolutely. The FDA should be fully funded. As much as they think they need.

But that needs to balance a serious caution against approving drugs too quickly or rushing the approval process. Drugs can help people, but they can also hurt. With a new drug, there may be side-effects that don't show up until after a drug has been used for a long time.

Admittedly, this is less of an issue for generics. I would imagine that underfunding FDA generic approvals is a favor for patent holding drug companies.

Posted by: zosima | February 22, 2010 2:49 PM | Report abuse


you should really stop being a GWB/Republican apologist. It won't get you any points around here (well except from msoja). Everyone knows Part D was an unfunded cost nightmare.

I'm still waiting for the oversight meetings on Pharma. You know like the ones where they took insurers to task all last summer. how about learning how Pharma slightly adjust a drug to gain more years on the patent. How they pay off generics not to make a generic.

Are those doctor funded vacations (er, uh seminars) still going on???

Posted by: visionbrkr | February 22, 2010 3:14 PM | Report abuse

* Everyone knows Part D was an unfunded cost nightmare.*

I didn't defend the unfunded part. I defending the "get Pharma hooked on the part D money" part. If you want to use your market buying leverage to negotiate, the first thing you do is make yourself a big player in the market, and one of the ways to do that was bribe Pharma into letting them, until they get addicted to having the federal government as a customer.

*Are those doctor funded vacations (er, uh seminars) still going on???*

Yes. They're just not allowed to get free pens, anymore, so it's all above-board!

Posted by: constans | February 22, 2010 3:20 PM | Report abuse

and now that we've got them hooked like the junkies that they are any idea in what decade we "reel them in" because it seems that's what Senator Dorgan wanted to do and yet he was rebuffed.

Also do you think the docs won't get their "doc fix" when the time comes and then this whole "defecit neutral" farce will come apart if anyone's paying attention? Come on now you're not that naive.

Posted by: visionbrkr | February 22, 2010 3:34 PM | Report abuse

"But that needs to balance a serious caution against approving drugs too quickly or rushing the approval process." No, no, no. We are way too far over on that issue already. It takes somewhere around 15 to 20 years to approve a new cancer drug, and costs not much less than a billion dollars. The main reason, if I understand right from friends in the field, is the third stage major clinical test that involves so many people and takes so long.
If you cut these back, many more people will die or be harmed by imperfectly tested drugs. But I'm pretty sure that it will be far fewer people than die today because it takes so long for life-saving drugs to get to market. And there would be many more drugs made available, because it would be much cheaper.

Posted by: MikeR4 | February 22, 2010 4:23 PM | Report abuse

MikeR4 - The collectivists aren't really concerned about what's best for individual people, much less what is right under principles of liberty. Instead, it's all about control, and imposing their vapid idiocies onto others, unintended consequences and looming tyranny be damned.

Posted by: msoja | February 22, 2010 6:33 PM | Report abuse

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