W

hen David Mitchell learned he had an incurable blood cancer seven years ago, the out-of-pocket cost for a month’s supply for one of his medicines was $42. By 2016, it had jumped to $250.

A lower-cost generic wasn’t an option because Celgene, the drug’s manufacturer, refused to provide samples to generics makers for the product testing they need to do to win marketing approval. Why? The company cited constraints imposed by a regulatory program meant to ensure drug safety.

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  • I don’t get it. Why do they need free samples? Why can’t they just buy the drug at fair market value? A generic drug company is still a company. They have an R&D budget to buy things. Maybe I’m missing something or the author failed to explain why the samples are such a big issue. Alternatively, the FDA could just require a volume of samples and distribute them, and create policies like good Samaritan to protect frivolous lawsuits. I hate big pharma as much as most Americans, but this doesn’t seem like a hard issue to solve as it is being characterized here unless it isn’t fully being characterized

  • As I read your story, it gives the impression that the brand name drug companies have used their extensive powers to dominate the U.S. drug market. However, it is the generic industry that has increased its share of domestic drugs sales during my professional life from 50% to 60% to 70% to over 80% with the most recent numbers I have seen on the web. Perhaps the question your article should address is “What is a fair percentage for generic drug sales in the U.S.?” 90%, 95%, 99%? Remember, today’s brand name drug is the generic drug of the future. I believe that unless there is Hatch-Waxman reform (more Hatch, less Waxman), there may be an inadequate number of brand name drugs to copy for the generic industry to thrive in the future.

  • Decades ago, a little organization called Environmental Action launched the Dirty Dozen, a list of the 12 worst members of Congress based on their votes on environmental issues. Most were defeated in the next election. Perhaps it is time for a new organization to launch the Greedy Pharma. Is the market equivalent of voting people out of office a consumer boycott (when there are other alternatives to products in that company’s portfolio)?

  • I agree with the argument that generic version of drugs definitely help lower the healthcare costs. My question is when a patient takes a generic version of a drug and get serious side effect, whom the patient/lawyer can sue for his/her damage. There are several cases where the original manufacture got sued because the side effects are in the label and the generic company manufactures the exact copy of the drug that FDA allowed it to be equivalent. Another case would be when a default on the generic company is recognized in the quality of the drug, would the generic company and FDA be challenged?

  • My comment on this appears to have been moderated out- another kind of shame again! perhaps I will be allowed to say- people dying of hep C because of the price, do have a solution available, and it appears this news agency can’t tell you about it, so can I ask people to look up my FB page and you will see- there is hope, I am alive, it is not natural medicine, it is affordable access to DAA’s.

  • Brand companies have and will do everything to thwart competition. FDA has supported such actions under the threat of drug safety. It has been a mutual appreciation relationship. May be it will end.

    I have been told that Indian generic could not get samples and their executives will travel to the United States to buy suitcase full of brand drugs for testing.

    Till rubber meets the road all will stay talk. On one like to let go of their recipe. Pharma, legislators and regulators have a mutual appreciation society and bond. It is difficult to change old habits. Cheers.

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