Brian Mahn's dosing cup, syringe and bottle of the drug Xyrem, produced by Jazz Pharmaceuticals, at his home in Cypress, Texas, on Feb. 23, 2023.
Because of the drug’s serious side effects and its history of being abused for date rape, federal regulators required Jazz to come up with a plan to ensure that the drug was safely distributed to patients without falling into unintended hands. Jazz’s program included having a single pharmacy nationwide send the medication directly to patients.
In other words, for every month that Jazz could delay the arrival of competition, the company and its shareholders stood to benefit financially.But the tactics deprived narcolepsy patients of access to a new drug that was much easier to take. The ruling won’t have a big impact on the availability of Avadel’s product, which was going to come to market in the coming months regardless of the court’s decision. But it is important because it shows there may be limits to how far the drug industry can go in exploiting the patent system to lock out rivals.
The list price of the highest dose of each version is now more than $200,000 annually, according to SSR Health, a data company. Xyrem is now 19 times as expensive as it was in 2007, when SSR began tracking it. Brian Mahn, a 53-year-old consultant in Cypress, Texas, said he had to stop taking Xyrem several years ago because the dosing schedule was too difficult. He would sleep through the multiple alarms he set between 2:30 and 3 a.m., disrupting his family. Mahn would often take the second dose too late, leaving him with such severe brain fog in the morning that he was unable to drive to work.
Jazz’s REMS program consisted of a computerized system for tracking which physicians can prescribe a drug and having a single pharmacy ship the drug to patients nationwide. Jazz has taken this strategy to a new level, with its chief executive even bragging to investors about how its REMS patents would make it hard for a manufacturer of generic drugs to set up its own REMS program.
It’s always a good idea to demonstrate to your coworkers that you are capable of withstanding a tremendous amount of pain.
Our country puts profit above everything. I don’t think the US is the best place to live any longer. It’s better than most but it treats our working poor terribly.