You can buy generic birth control pills, HIV antivirals, and chemotherapy drugs, but you can’t buy generic insulin; it doesn’t exist. In fact, the history of insulin in the United States is a case study for how the brand-name-then-generic system can fail patients.
Generic insulin would certainly be a big boon to many Americans, five million of whom depend on insulin to manage their Type 1 and Type 2 diabetes, illnesses that are deadly when left untreated. For those without insurance, brand-name insulin costs $120 to $400 for a month’s supply. In 2014, the website Insulin Nation interviewed insulin users about their troubles. One person gave up doctor’s visits and teeth cleanings to buy her medicine. Another stocked up when he found it for a good price, and sent extra to a family member who couldn’t afford it.
Normally, companies start creating generics when big-name drug-makers’ patents expire. The generics sell for less because their makers didn’t bear the cost of discovering and developing the drugs. This should have happened to insulin already—the first patent for it dates to 1923. But a combination of patent-refreshing and generics companies’ reluctance to tackle making the insulin protein, which is hard to copy, has kept insulin patented and pricey, two physician-researchers report in the New England Journal of Medicine today.
“It’s hard to say that contemporary patients who cannot afford their insulin are well served by having as their only option an agent that is marginally more effective than those that could have been generically available 50 or 30 or 10 years ago.”
In recent years, some researchers and journalists have called out drug companies for “evergreening,” or making trivial improvements to drugs whose patents are close to expiring. The tweaks let companies refresh their patents and edge out generic competition. But insulin’s history of improvement isn’t a straightforward story of evergreening. Since 1923, companies have made insulin faster-acting, longer-lasting, and purer—all important changes. “Insulin today is demonstrably safer and more convenient to use,” researchers Jeremy Greene and Kevin Riggs write in the New England Journal of Medicine. But are the latest insulin therapies worth it for everyone? “It’s hard to say that contemporary patients who cannot afford their insulin (let alone the patent-protected glucometers and test strips required to adjust the dose) are well served by having as their only option an agent that is marginally more effective than those that could have been generically available 50 or 30 or 10 years ago,” Greene and Riggs write.
So why haven’t generics companies tackled making those older insulins? If you looked at insulin under a microscope, you’d see it’s much larger and more complex than most drugs, making it difficult for companies to copy. The U.S. Food and Drug Administration also regulates insulin differently from less complex drugs; the approval process is often more expensive. “Generic-drug companies have evidently not considered it worthwhile,” Greene and Riggs write.
That may change soon. At least one U.S. generics company is working on FDA approval for its own insulin. But as the diabetes website dLife argued in 2013, it would be a mistake to wait for the whole drug-approval system to work on its own. After all, over the last 90-plus years, it hasn’t.
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