Scott Gottlieb, MD, Outlines Steps Aimed at Lowering Insulin Costs

Skyrocketing costs are threatening diabetes patients’ prescription adherence and access to insulin, a critical hormone that regulates sugar metabolism, said Scott Gottlieb, MD, commissioner of the US Food and Drug Administration.

“It remains the seventh leading cause of death in the US and accounts for $330 billion in annual health care spending,” said Dr Gottlieb in a statement. “While some patients with Type 2 diabetes can control their diabetes through diet, exercise, and oral medications, more than seven million diabetics require daily insulin injections to maintain glycemic control and reduce the risk of health complications.”

Dr Gottlieb recognized that lowering drug costs is a vigorous process but suggested that one pathway to improvement lies in competition. “This is particularly true following the introductions of generics, especially when there are three or more generic competitors—which has been shown to bring down prices more sharply than with only one or two generic competitors.”

Earlier this month, pharmaceutical company, Eli Lilly announced a plan to sell a 50% cheaper, generic version of its rapid-acting insulin Humalog. While Humalog will remain on the market, the new generic will cost $137.35 per vial or $265.20, according to the company.

The FDA commissioner added, “A robust pathway for generic competition is critical to expanding drug access and promoting public health. The FDA has worked hard to encourage generic entry after patents and other exclusivities have lapsed. Ours is one of the most competitive generic markets in the world.”

A recent analysis conducted by the Health Care Cost Institute shows insulin costs per patient with type 1 diabetes have almost doubled from 2012 to 2016. Patients with type 1 diabetics spent $2864 per person on insulin in 2012, compared with the exponentially increased cost of $5705 per person in 2016.

“Not all parts of the pharmaceutical market have been equally open to competition from more affordable products,” said Dr Gottlieb. “This is especially true for biologic medicines, which are typically complex molecules produced by living cells, and are increasingly the backbone of modern therapy.”

In his statement, Dr Gottlieb pointed out that with the 2010 congress-approved Biologics Price Competition and Innovation Act, the FDA now has “the authority to implement a pathway for approval of biosimilar and interchangeable products, to open biologics to competition, ultimately providing more treatment options, increasing access to lifesaving medications, and potentially lowering health care costs.”

Moving forward, the FDA has plans to advance new policies to promote competition in the biosimilars market, as well as improve efficiency in the workflows for development and approval processes.

"Transitioning biological products currently regulated as drugs to being regulated as biologics will enable—for the first time—products that are biosimilar to, or interchangeable with, these products to come to market...The transition of insulin from the drug to the biologics pathway will open up these products to biosimilar competition," stated Dr Gottlieb. "We’re already seeing robust activity among sponsors seeking to bring forward biosimilar copies of insulin. The framework for demonstrating that these insulin products are interchangeable should also be efficient and achievable."

Dr Gottlieb is set to formally leave his position over the next few days but remains busy wrapping up projects, as well as releasing additional statements on treatments for nicotine-addicted youth, steps to advance regulatory pathways for cannabis, and artificial intelligence-based medical devices.

—Edan Stanley

Reference:

U.S. Food and Drug Administration. Statement From FDA Commissioner Scott Gottlieb, M.D., On The Agency’s Continued Efforts To Bring Competition To The Insulin Market To Lower Prices And Expand Access. 2019. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634999.htm. Accessed April 2, 2019.