7 ms·
This old drug was free. Now it’s $109,500 a year
- perilunar 9y agoThis is the problem right here: "Although Keveyis is actually a decades-old drug, its federal approval for periodic paralysis came with a seven-year period of exclusive marketing rights." A decades-old drug should not have any IP left.
- notlob 9y agoThe exclusivity period is intended to incentivize developing old drugs for new indications. What would you suggest instead of the exclusivity window?
- otterley 9y agoWhat “development” are you referring to, exactly? The alternate indications in many cases are already well known (as they were in the referenced article).
- notlob 9y agoThe clinical studies needed to support receiving approval to market the old drug for a new indication, as well as whatever lifecycle management and post-marketing surveillance activities (Phase IV) that are required. The alternate indications may be well-known but marketing for an off label indication is not permitted (as in, they actually jail CEOs and executives for that).
- toomuchtodo 9y agoGovernment manufacturing of generics by the CDC or NSF. It is the only method by which you can guarantee supply as well as ensure transparency in the process.
- notlob 9y agoI can't say I understand why you selected those two organizations: the CDC doesn't have pharma manufacturing expertise that I am aware of (interested to hear of what you know on that angle); the NSF is non-medical and it's a grant agency, no labs. I should also note that even if they were chartered for this sort of work and were working on it, they would face the same source material supply problems facing commercial groups that result in some supply interruptions, and the basket of problems associated with manufacturing small amounts of drugs. There are many non-profit and academic institutes that are working on the problem of generic drug costs holistically, including figuring out how to produce APIs (in pharma, API is active pharmaceutical ingredient) from plentiful source materials and how to produce the APIs by flow processes so that small quantities of drugs are more economical to produce. They're doing good work but it's a hard problem, experienced execs and leaders are difficult to come by, and getting funding in biotech is far more difficult than getting funding in IT. They do receive support from NIH, FDA, DARPA (making drugs at a CSH in the middle of Afghanistan is useful), big pharma (being able to make drugs cheaper is generally of interest), and philanthropic groups. Many smart and talented people are "on it!", good progress is being made, but it is a hard problem.
- georgiecasey 9y agohttp://archive.is/BOf2k http://archive.is/BOf2k if you get stuck behind the paywall like me
- pnutjam 9y agoI'm not sure how Single payer could ever be less efficient then our current system.
- conanbatt 9y ago"It used to be $109.000 a year. Now its $209.000 a year." Drugs are not expensive because they are private, they are expensive because they are artificially scarce by yours truly, the Single Payer.
- chroem- 9y agoThis kind of insanity makes me wish we would just abolish the legal notion of intellectual property already. It flies in the face of everything that the free market stands for by actively blocking competition. Yes, you can come up with all sorts of contrived allegories for why IP might be beneficial, but all of those fail in practice and are vastly outweighed by IP being used anticompetitively. This article hits especially close to home since I have a very rare eye condition that's destroying my sight, but the drug to adequately treat it costs $67k a year and isn't covered by insurance because of the high cost. So now I'm left making the most of my new life on significantly cheaper but less effective drugs.
- maxerickson 9y agoThese situations with old drugs are more a matter of FDA certification than IP.
- chroem- 9y agoWhile I can't speak as much to the case in article, my problem is due to IP restrictions. Though companies buying the rights to daranide sounds an awful lot like IP too.
- notlob 9y agoHow would you propose recouping the cost of developing a New Chemical Entity into an approved drug without the exclusivity provided by IP?
- calvinbhai 9y agoBasically, this is the pharma - health insurance industry nexus, that jacksup prices of drugs, making it looks like an amazing deal for those getting the drugs through insurance. For a new patient needing this drug, he/she would think "wow, I pay only $1000 a month of insurance, and I'm getting $109,500 a year worth of drugs for $5000 only." Without fixing pharma+healthInsurnace nexus, healthcare in the US feels like a ripoff, whether you are rich or poor.
- RcouF1uZ4gsC 9y ago>Anderson, for example, pays nothing. Buried in this article is the fact that the person they introduced at the beginning of the article is still paying nothing for this drug. Seems like much ado about nothing.
- anigbrowl 9y agoEveryone else in the insurance pool is paying more than they need to as a result.