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For a fantastic discussion about the Byzantine process for generic drug approval, I recommend a recent episode of EconTalk[0]. The guest wrote a book called "D
by tacon 9y ago
For a fantastic discussion about the Byzantine process for generic drug approval, I recommend a recent episode of EconTalk[0]. The guest wrote a book called "Drug Wars: How Big Pharma Raises Prices and Keeps Generics off the Market"[1]. When up to half a billion dollars of revenue is at stake, the drug companies have incredible incentives to delay or prevent generics coming to market. Believe or not, they often simply refuse to give a sample of the old drug to the generic company. No sample to compare, no FDA approval. It is illegal to dispense a drug without a prescription, and the sample is not for a patient, so it can take some maneuvers to get a legal sample. Or the drug company can change a tiny feature of the drug, re-patent the new drug, and then destroy/withhold all the old drug. No old drug sample, no FDA approval of an "identical" generic. The drug companies will contract with a generic company that never, actually gets to production (wink, wink). Those contracts are finally being understood by judges, so now they are going to a second level of contract obfuscation that is even harder to notice, but still keeps the generic off the market.
[0]http://www.econtalk.org/archives/2017/06/robin_feldman_o.html http://www.econtalk.org/archives/2017/06/robin_feldman_o.htm...
[1]https://www.amazon.com/Drug-Wars-Pharma-Raises-Generics/dp/1107168481/ https://www.amazon.com/Drug-Wars-Pharma-Raises-Generics/dp/1...
- rtpg 9y agoIs this a worldwide problem? Or is this really an American failing?
- toyg 9y agoSome of these techniques (like tweaking and repatenting a formula) are definitely used worldwide.
- maxerickson 9y agoI think it is worse in the US. India goes as far as waiving patents if a drug is too expensive.
- sseth 9y agoThere are companies which have patented drugs in India, but do not make their drugs available in India. The Indian Patent Law allows for compulsory licensing of such drugs to another manufacturer under certain conditions which meet public interest. This is not a free for all - there are significant legal tests that the manufacturer has to meet to get the CL, and i think only one or two cases have been granted. This provision of indian IPR laws has led to having India being put on an IP watchlist in the USA, though India's laws are compliant with the TRIPS agreement.
- steiger 9y agoI live in Brazil and generics for drugs which patents are expired are widely available, accounting for 30~40% of all drug market. If I'm not mistaken, we even broke patents in some cases (HIV drugs), which is cool.
- roadnottaken 9y agoWhy is that cool? Intellectual property law is necessary for industries like Pharma. No IP, no new drugs.
- yequalsx 9y agoThe people who do the actual discovery are not paid an exorbitant amount of money. They mostly just want to do research and solve problems while living a comfortable life. A pharma company making billions in profit isn’t necessary. It’s just the common way it currently is done. There are other ways to accomplish the same goal. We could try to replicate Jonas Salks’ way Of doing things.
- roadnottaken 9y agoI work in drug discovery. You're right that the bench-scientists don't usually get rich. But it's an extraordinarily risky, expensive, and unpredictable business and for every billion dollar drug there's a graveyard of failed companies and projects that didn't make it. The only business reason to take those risks are for a chance at patent-protected profit. And those bench scientists wouldn't have labs to work in if investors and rich companies weren't willing to pay for it.
- tkahnoski 9y agoI was skeptical of this graveyard because it gets referenced a lot, largely due to how we humans constantly ignore the sunk-cost fallacy all the time. BUT it turns out the FDA is what prevents that from happening, and yes less drugs are getting approved. https://www.reuters.com/article/us-pharmaceuticals-success/success-rates-for-experimental-drugs-falls-study-idUSTRE71D2U920110214 https://www.reuters.com/article/us-pharmaceuticals-success/s...
- Symmetry 9y agoIt's definitely a US only problem. There are, for instance, multiple competing competing brands of EpiPen competitors in Europe. In the US the FDA's mandate concerns safety only and private entities can sue it to force it to do its job if they think it isn't. Which makes it easy for big companies to launch lawsuits alleging that their potential competition can't prove that they can produce drugs as safely as the incumbents.
- jopsen 9y ago> The drug companies will contract with a generic company that never, actually gets to production (wink, wink). Sounds like I should setup shop as "generic drug company" and land me one of those contracts where I promise to never reach market :)
- mmanfrin 9y agoFinally, a career fitted to my sharp ability to never follow through on goals.
- gremlinsinc 9y agoSounds like a good career move for Bighead (Silicon Valley)
- zerostar07 9y agoSorry, i have a patent on that.