WASHINGTON — FDA Commissioner Scott Gottlieb blasted insulin makers Tuesday for what he called unacceptably high prices for a decades-old drug. And he rolled out a slate of new guidances for the industry he says will spur competition in the insulin market and bring down the drug’s cost when they take effect in 2020.
But in a speech at this week’s FDA/CMS Summit, Gottlieb stopped short of endorsing policies gaining steam on Capitol Hill that would dramatically change how insulin makers do business.
“We’ve heard frequent reports of patients rationing insulin, and in some cases dying because they can’t afford the injections they need to survive,” Gottlieb said Tuesday, according to prepared remarks shared with STAT. “These tragic stories aren’t isolated occurrences. And they’re not acceptable for a drug that’s nearly a century old.”
Insulin is increasingly being held up by policymakers and drug pricing activists as an example of the human toll of high drug prices. Three companies — Eli Lilly, Novo Nordisk (NVO), Sanofi (SNY) Aventis — control 90 percent of the insulin market, and that lack of competition has led to escalating prices in recent years.
But that lack of competition is partially due to the way insulins have historically been regulated.
Insulins are biologic drugs, meaning they’re made from living cells. But they haven’t been regulated the same way. Neither have copycat or generic insulins, known as follow-on insulins, been regulated the same way as most copycat biologic drugs, known as biosimilars.
That’s set to change in 2020, when insulins will be regulated as biologics, and, thus, the copycats will be regulated the same way as biosimilars.
That transition was written into the 2009 Affordable Care Act, and Gottlieb expects it will lead to more competition and lower prices for patients. “This is a watershed moment for insulin products,” Gottlieb said Tuesday, about the 2020 transition.
Two of the new guidances flesh out how the FDA will regulate the copycat insulins after that transition.
The guidances explain, among other things, that insulin products will not be eligible for a lucrative 12-year exclusivity period, despite now being regulated as biologic products, which typically are protected from competition for 12 years.
While Gottlieb said these new policies “should help usher in a new era of competition for these products that’ll lead to lower prices and better access,” they do nothing to affect what patients are paying now. Instead, they mostly address wonky questions being mulled in drug industry board rooms, like what a company should do when it’s submitting an insulin application that the FDA isn’t likely to approve before 2020.
That might not placate activists and lawmakers, who increasingly are calling for drastic action to bring down the cost of insulin.
The Congressional Diabetes Caucus, for example, released a slate of policy ideas in November that included requiring insulin makers to report how they set their prices.