Could there finally be a light at the end of the tunnel for skyrocketing insulin prices? Maybe, but it's not going to happen overnight...

Our Diabetes Community is abuzz yet again on the issue of high insulin prices and generic versions of this life-sustaining medication after both the FDA Commissioner and powerful presidential hopefuls for 2020 have made aggressive public statements. Meanwhile, a new documentary focusing on the broader drug pricing issue mentions insulin, even as grassroots D-advocates stoke the fire in their state legislatures as we head into the next year.

All in all, 2019 is shaping up to be one of heightened attention and discussion -- even if we don't see any immediate insulin price drops.

Here's the latest on what's happening:

 

FDA Commissioner Clears Path for 'Biosimilars'

In one of the most visible moves to date, FDA Commissioner Scott Gottlieb on Dec. 11 called out the outrageous insulin prices and laid out guidelines on how the federal agency will be dealing with upcoming changes expected to take effect by 2020.

Remember that insulin is different than other drugs because it is considered a "biologic" -- meaning a more complex medication that can't be just simply re-produced as a generic, the way many others are across the world. Though it's a century old, there is no real generic insulin; only in the past few years have we've seen anything comparable to that, known as a "follow-on" biosimilar product, which is pretty much a copycat form of insulin that for scientific reasons does not constitute a generic. As such, it must go through the entire drawn out regulatory pathway -- a longer, more expensive process than what generic drugs usually face.

In the US, the first copycat based on Sanofi's Lantus came in 2015 with Lilly's Basaglar. Since then, Sanofi has also launched its short-acting Admelog insulin based off Humalog. There are more on tap in the coming years, too.

This is where the FDA's new 2020 rules come into play.

Starting that year, insulins like this will no longer be considered "drugs" at all, but rather fall into a separate category of biosimilars, allowing for an easier and more clear review process to get these off-brand insulin products to market. In other words, starting in 2020 manufacturers can use an "abbreviated pathway" for FDA approval.

FDA Commissioner Gottleib believes that will help jumpstart competition for generic drugs, including insulin that he mentioned specifically in his recent remarks.

“Access to affordable insulin is literally a matter of life and death for these Americans," he said in a statement. "… Limited competition in the insulin market has helped keep prices artificially high. Today, according to the Congressional Research Service, three firms control 90% of the global insulin market, and produce all the insulin used in the US. As a result, 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. And they’re not acceptable for a drug that’s nearly a century old.”

He also cited the outrageous insulin list price increases over the years, and mentioned insulin co-discoverer Dr. Frederick Banting by name, noting that in 1923 that Canadian research team received a US. patent and sold that to the University of Toronto for only $3 -- because they didn't create insulin for profit, but for the betterment of humankind.

In his statements, Gottlieb also called out the other players in the insulin pricing machine that play a part in driving up these pricetags: “Drug manufacturers use rebates generated by the gap between their rising list and net prices to pay for preferred status on pharmacy benefits managers (PBM) formularies. Monopoly profits benefit every member of the drug supply chain, except the patients who most need access to affordable products.”

Of course it will take some time to chip away at these issues that have created the huge crisis in drug prices, but huge kudos to FDA for stepping up on this front!

 

Generic Drugs Made by the Federal Government?

Massachusetts Sen. Elizabeth Warren, who many believe will put her name in the hat for the 2020 presidential election, proposed an ambitious piece of legislation on Dec. 18 called the Affordable Drug Manufacturing Act. It would establish an Office of Drug Manufacturing that would basically put the federal government in the role of mass-producing generic drugs. At least 15 different generic drugs -- including insulin -- would be required in the first year, to make up for what the newly created office states is a "failure in the market." Three standards are proposed for determining a “market failure" drug:

  • if no company is producing the generic drug;
  • if just one or two companies are making the drug and there is a shortage or a recent price hike higher than medical inflation; or
  • if the drug is on the World Health Organization’s “essential medicine” list (as insulin is) and the price is deemed too high while being produced by only one or two companies.
  • the bill allows the government to either produce the medication itself or contract the manufacturing to an outside company. A "fair" price would be set to cover the costs of making the drug.

The senator wants production on these generic drugs to start a year after the law's enacted, but that just may not be realistic. Public comments from health policy experts in the days following this announcement pointed to that a government-run manufacturing of generic medications would be a huge, complicated task that could take years to put in place.

This isn't a completely novel idea, as it's been pitched before. Recently, a network of hospitals created a new non-profit called CivicaRx in order to create their own generic drugs. In fact, insulin is likely on the radar for that group as one of the founding members has three brothers with T1D and comes from a family whose father is an endocrinologist.

But would this all be safe? Quite a bit goes into insulin production, and would there be adequate measures in place to ensure the insulin is as good and effective as we have now? That's a big question, especially as the FDA previously i 2016 forced the National Institutes of Health (NIH) to suspend its drug manufacturing facilities over quality concerns.

Whatever the answer, something must be done.

In the news release announcing this legislation, Warren stated: “In market after market, competition is dying as a handful of giant companies spend millions to rig the rules, insulate themselves from accountability, and line their pockets at the expense of American families."

She refers to the pharma industry as one of the largest cartels in US history, and she penned a letter to the Senate calling for an investigation into price-fixing schemes. All of that fits in with what other lawmakers have proposed in trying to reign in big pharma, now also with backing from the FDA.

 

More Public Outcry on Drug Prices Wanted

Recently, an hour-long documentary was released tackling this topic: "Drug $: The Price We Pay." The film mentions many conditions and their related medicines, including diabetes and the #insulin4all movement that has been gaining steam over the past few years on the issue of insulin pricing. Here's a trailer for the film released Dec. 15, and the full film can be viewed online here. The hope is that this film will stir even more grassroots advocacy.

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There is also more lobbying for state and federal level policy changes in the works as we move into 2019, calling specifically for prescription drug pricing transparency and potential price controls. Whether we see any Congressional movement on this, despite all the rhetoric and recent healthcare debates, remains TBD.

Even as these regulatory and policy level moves are being made, public outcry remains the linchpin to effect real change. So we encourage our community to keep up the drumbeat!