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As drug prices climb and the Trump administration works over ways to lower them, FDA commissioner Scott Gottlieb, M.D., has homed in on insulin prices as his agency’s next target. For a product that’s nearly 100 years old, the commissioner said prices are too high, forcing diabetes patients to ration their drugs and sacrifice their health for financial reasons.

So, Gottlieb’s agency is ready to do what it can to help, though that help won’t come until 2020 or later. At a CMS summit Tuesday, he outlined the FDA’s plan to reclassify insulin products as biologics in March 2020, moving away from their current classification as drugs.

The new classification will allow biosimilar drugmakers to develop their own versions of insulins that can be substituted at the pharmacy, creating competition and lowering costs, Gottlieb said. But new competition won’t come immediately, and biosims have been slow to take off in the U.S. due to patent and contracting issues.

Still, Gottlieb touted the change as a “watershed moment for insulin products, which millions of American take each day to maintain stable blood glucose.”

“There are currently no approved insulin products that can be substituted at the pharmacy level,” he said, according to prepared remarks. “One reason is that it was hard to bring a substitutable generic insulin to the market under the conventional drug pathway. The biosimilar pathway should make this kind of competition more accessible.”

As Gottlieb pointed out, three drugmakers control all of the U.S. insulin supply, and prices in the category have grown dramatically in recent years. He cited a study that concluded that list prices for four insulin categories grew 15% to 17% per year from 2012 to 2016. Another study found that list prices for one type of insulin grew 600% over 14 years. The FDA commissioner called the changes to bolster competition “long overdue.”

Due to high costs, Gottlieb said, “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.”

“These tragic stories aren’t isolated occurrences,” he added. “And they’re not acceptable for a drug that’s nearly a century old.”

Sanofi, Eli Lilly and Novo Nordisk produce the bulk of the world’s insulin. The companies have faced years of scrutiny over their pricing as the spread between list prices and net prices has grown, forcing patients to pay more out of pocket. Meanwhile, the drugmakers themselves have been paying out higher rebates to secure favorable formulary coverage, hurting their financial performance. Recently, Minnesota’s attorney general Lori Swanson sued the companies for “deceptive” pricing.

Before Swanson’s lawsuit, the companies faced years of heat from lawmakers and others over escalating insulin prices.

Gottlieb said at the summit that the “new pathway we’re laying out today should help usher in a new era of competition for these products that’ll lead to lower prices and better access.”

The commissioner’s announcement comes as the Trump administration works to lower pharmaceutical costs following years of outcry over drug pricing. So far during Gottlieb’s time at the FDA, the agency has boosted generic drug approvals and worked to combat regulatory “gaming” that stifles competition, among other initiatives.

By Eric Sagonowsky

Source: Fierce Pharma