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Dr. Derek Lowe, from In the Pipeline, writes:
So since drug pricing and FDA regulations are so much in the news, it would seem like the perfect time for a small company to game the system for big profits, right? That's apparently what Marathon Pharmaceuticals believes. They just got approval for deflazacort, a steroid, as a treatment for Duchenne Muscular Dystrophy.
[...] So what's not to like? Well, this drug has been around since the early 1990s. Marathon most certainly did not invent it. Nor did they think of applying it to DMD patients – the biggest clinical trial of the drug for that indication was done over twenty years ago, by someone else. DMD patients in the US were already taking the (unapproved) drug by importing it from Canada. Marathon just dug through the data again and ran a trial in 29 patients themselves, from what I can see. I should note that this is not any sort of cure, nor does it address the underlying pathology of the disease. The steroid treatment makes muscle strength in DMD patients stronger – barely. But even for that benefit, US patients will now have to get it from Marathon at something like 50 to 100 times the former price.
[...] So while I defend the FDA's function of making it tough on new drugs (making them prove safety and efficacy), I cannot stand how loose they are with old generic compounds. The agency hands out extremely valuable rewards like lollipops in these cases – a priority review voucher can be sold for hundreds of millions of dollars
[...] And they're also allowing the likes of Marathon to make the rest of the drug industry look like greedy sociopaths. Marathon, Catalyst, T*ring and all the rest of the people who are pulling these tricks have the word "Pharmaceuticals" in their name, but they are not drug companies. They discover nothing. They do no research. They take virtually no risks. They exist only to play legal games and watch the money roll in.
[...] As for the FDA, the agency probably can't change this on its own, though, even if it wants to – Congress has to act to give them the authority to deny market exclusivity or priority review vouchers under some conditions. Either that, or we should rethink these incentives entirely, because they are (clearly) too easy to exploit for fast bucks.
https://en.wikipedia.org/wiki/Deflazacort
Also at ArsTechnica.
(Score: 3, Informative) by migz on Sunday February 12 2017, @09:57AM
I cannot understand why companies are always painted as the culprits, when the problem is one that has been created by government. In this case the FDA should not be involved at all in regulating anything except fraud.
If company A invents a drug, then that is great. Some would argue that as a result of those costs, companies should be granted a monopoly to license that drug. I don't think that is a good idea. A large chunk of those costs are invented by the incumbent in conspiracy with the regulators to keep competition out. This is the modern equivalent of a guild system. Anybody should be allowed to produce anything in their basement, and the FDA should only be there to prevent fraud.
If someone sells chalk pills as aspirin, then they can get involved. They can even have a little FDA approved logo to show that they "have been tough". Heck if would probably be a good thing if there were private competitors to the FDA that had their own "safety marks". If I want to buy cut price acetylsalicylic acid from the cafe, nobody should stop me. If Beyer pharmaceutical's want's to put an Asprin(R) on theirs and charge more, then they should be allowed to. Nobody else should be allowed to as long as they control the trademark, since that would be fraud. The FDA should however leave everybody else alone.
(Score: 2, Informative) by Anonymous Coward on Sunday February 12 2017, @04:06PM
In this case the FDA should not be involved at all in regulating anything except fraud.
...
If someone sells chalk pills as aspirin, then they can get involved.
You are hopelessly naive. The FDA wasn't created out of nowhere. It exists because people were being killed. [wikipedia.org]
No amount of after the fact action can undo death or serious injury.
The FDA is imperfect because it is a creation of imperfect humans, but your 'solution' is a recipe for far worse results.
We've already been down that path.
(Score: 2) by migz on Sunday February 12 2017, @05:08PM
> You are hopelessly naive.
Ad hominum
> The FDA wasn't created out of nowhere.
I never claimed that it was.
>It exists because people were being killed.
Yep, that's fraud.
> No amount of after the fact action can undo death or serious injury.
Yep.
>The FDA is imperfect because it is a creation of imperfect humans,
Yep.
>but your 'solution' is a recipe for far worse results.
Nope. You have not refuted a single word, nor have you presented anything in support of your contention.
> We've already been down that path.?
Really? There was a time that the FDA only acted as a vetting agency, and had competition? When was this?
(Score: 0) by Anonymous Coward on Sunday February 12 2017, @05:48PM
> Ad hominum
Nope. For your future reference:
Ad hominem: "You are wrong because you are stupid."
Not ad hominem: "You are stupid because you are wrong."
(Score: 1) by Roger Murdock on Monday February 13 2017, @12:43AM
>>It exists because people were being killed.
>Yep, that's fraud.
It's not fraud if the deaths were from compounds that were accurately listed.
> nor have you presented anything in support of your contention
Neither have you really, just a bunch of opinions and something about an FDA conspiracy. How is any research going to be funded if the final product will just be copied as soon as it hits the market? Or do you think R&D costs are actually so low (if it weren't for the FDA) that being (marginally) first to market would make up for it?
(Score: 2) by sjames on Sunday February 12 2017, @05:46PM
There is justification for regulating novel drugs and inactive ingredients in drugs, but fundamentally, the FDA is just as much after the fact as anyone else. They do not have anything in place that could actually prevent a bad actor from including a toxic substance into a remedy except the knowledge that the after-the-fact consequences would be ruinous.
It's fine that we have the FDA provide a means by which a novel substance can become approved for human consumption. But once it is, the FDA should butt out other than periodic checking that the drug contains what it says it does in the amount it claims (or perhaps the FTC should do that, they seem to manage it without quadrupling the price).
(Score: 0) by Anonymous Coward on Sunday February 12 2017, @04:12PM
Some would argue that as a result of those costs, companies should be granted a monopoly to license that drug. I don't think that is a good idea.
Do you have a better idea?
Doing research, developing drugs, and running clinical trials all cost money. That money has to come from somewhere and many people are not happy with tax money even paying for the first part.
(Score: 2) by migz on Sunday February 12 2017, @05:12PM
> Do you have a better idea?
Sure. Don't grant monopolies.
> Doing research, developing drugs, and running clinical trials all cost money.
Sure. None of those should be required to manufacture and distribute substances.
> That money has to come from somewhere
No it does not. You only need the money if the FDA forces you to do it. Otherwise people can find other ways to fund research, trials, and drugs.
> ... any people are not happy with tax money even paying for the first part.
I'm not happy with tax money paying for ANY part of this WHATSOEVER. The FDA should be self funding.
(Score: 0) by Anonymous Coward on Sunday February 12 2017, @10:43PM
Otherwise people can find other ways to fund research, trials, and drugs.
Like what?
Without patent protection, how would pharmaceutical companies fund the research necessary to develop new drugs? Should they try to rely on trade secrets, enter into exclusive contracts with healthcare providers, or should they just stop making new drugs?
(Score: 2) by sjames on Sunday February 12 2017, @10:09PM
The FDA is a serious enabler but Marathon and their ilk play it for all it's worth. You may leave your backpack on the bench at the park, but I'm still a thief if I take it away, remove your ID, and treat it as my own.