Everyone wants insulin to be more affordable. At least, that’s what everyone says.
And it’s not just talk. Parents have protested deadly insulin prices, biohackers are working feverishly to create a home-brewed, patent-free insulin, and some have resorted to extra-legal methods of obtaining their monthly vials. It’s not a matter of saving a few bucks—it’s a matter of life and death.
Even the FDA is fed up. And they have a plan.
In a December 2018 press release, Commissioner Scott Gottlieb, M.D., writes passionately about the FDA’s obligation to protect patients and promote innovations as well as the agency’s plan to do just that.
Gottlieb talks extensively about the importance of generics in driving both affordability and innovation (companies must discover new drugs once generics come out in order to maintain profits). The FDA broke its record for number of generic approvals in fiscal year 2018.
“The result of this progress is that we openly talk about curing cancers that were recently fatal, or inherited pediatric diseases and blood disorders that often obligated children to lives of suffering and lives cut short,” the commissioner said. Generic drugs, he says, have saved patients about one trillion dollars over the last decade.
Then comes the “But.” Biologic medicines like insulin, which are made from living organisms rather than chemically synthesized, haven’t benefitted from the same robust competition as other drugs, and therefore have fewer generics available. (And all the insulin users said, “No kidding.”)
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Here are 3 things the FDA plans to do to increase competition and the availability of generic insulin drugs in 2019:
1. Create an abbreviated pathway to bring biologics to market
One of the challenges to insulin competition is that biologic drugs are hard to make and hard to approve. These challenges are designed to keep patients safe, but in the case of insulin, the resulting lack of affordable options has become a danger in itself. The regulatory process, including clinical trials, can cost around $30 to $250 million.
In summer of 2018, the FDA released a plan to create even greater efficiency in the approval process for biosimilar drugs (a drug substantially similar, but not exactly the same, as a current biologic drug). This will save companies time and money, increasing motivation to create generic insulins. The plan will also improve patient and provider education.
2. Address branded drug companies’ “gaming” of FDA requirements
Commissioner Gottlieb specifically calls out drug companies that abuse limited distribution systems, sometimes related to “Risk Evaluation and Mitigation Strategy programs” (REMS). These programs were designed to keep consumers safe by adding distribution regulations for potentially dangerous drugs.
But these programs can be abused when drug companies use them as a way to avoid providing reference samples to companies trying to get a biosimilar drug approved—potential competitors can’t see if their product works the same way as a branded product if they can’t get access to it. “…too many branded products are still misusing these programs as rhetorical smokescreens to hide anti-competitive behavior,” the commissioner said. “We’re not going to be partners to these deceptions.”
The FDA will start issuing letters to reference product companies directing them to allow the biosimilar applicant to access a sample. This will mean that branded companies can’t claim they’re not sharing in an effort to comply with REMS.
The FDA will also take actions to make it easier for biosimilar manufacturers to use reference products from other countries where they can more easily get reference products for a lower price.
3. Change the way insulin is regulated
Certain biological products, like insulin, which have traditionally been regulated as drugs, will now be regulated as biologics. That means that insulin will be subject to competition from biosimilars and that the anti-evergreening provisions designed to keep companies from retaining exclusive rights for too long will apply to insulin.
And just because current insulin drugs will transition to the biologics pathway, they won’t suddenly gain a new set of exclusivities. “They don’t get to start benefitting from the 12 years of exclusivity that the law grants to newly licensed biologics, just because these drugs—some of which were approved decades ago—are being treated as biologics for the first time,” the commissioner said.
Once an interchangeable biosimilar insulin is available, it can be substituted for a branded product at the pharmacy, hopefully leading to big consumer savings.
“Change won’t happen overnight. But we’ve crafted this policy to meet the needs of patients. It’s an opportunity that can’t come soon enough for the thousands of Americans who struggle to pay for insulin.”
Importance of generics
The price of generic drugs is tied to the number of generic options on the market. This explains why generic insulins aren’t currently much more affordable than name-brands options. But once more generics are available, the FDA hopes that generics will save consumers 80 percent or more on their insulin costs.
But will enough generics enter the market? “Given our long experience regulating insulin products, and high interest among sponsors who are proposing to develop interchangeable insulins, we’re confident that interchangeable insulins… will be attainable after the transition to deemed BLAs [Biologics License Applications] in March 2020.”
The FDA hopes that clearer guidance and easier regulation processes will motivate research and development companies see the profitability of bringing new generic insulin options to market even as the cost of insulin decreases.
It’s a hope we all—quite impatiently—share.Whizzco