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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: 0) by Anonymous Coward on Sunday February 12 2017, @02:22PM
Step 1: allow imports from other reasonable countries.
Step 2: give the FDA the ability to call out sham differences where two drugs are different enough to get different rules but essentially the same
Step 3: perhaps include price versus benefit into the mix of things considered during patent and drug approval proceedings
Step 4: tell Marathon that under the new rules, their 'invention' does not add to the availability of treatments and so no longer qualifies for a monopoly
Step 5: (For extra credit) consider penalties for those gaming the system
If you believe in a fundamental right to medical care, the pharma is not just another industry.
It, and the medical profession in general, have a responsibility to help folks.
This doesn't mean they can't make a good living.
Just not a crazy one with contrived scarcity, non-productive efforts, and a general attitude of anything for a buck.
These special rules are there to support bringing new treatment options where it helps the patient.
They are not there to cause windfall profits.