DeGette introduces bill aimed at bringing down cost of insulin

Apr 1, 2019
Press Release
Legislation seeks to make permanent a new FDA fast-track approval process for generic forms of insulin

WASHINGTON, D.C. – A bipartisan group of lawmakers introduced legislation today seeking to bring down the cost of certain biologic drugs, such as insulin, by making it easier for drug makers to get generic versions of those drugs approved by the Food and Drug Administration.

The legislation – led by U.S. Reps. Diana DeGette (D-CO) and Tom Reed (R-NY), who serve as the co-chairs of the Congressional Diabetes Caucus – would make permanent a new FDA policy that was put in place in December to help speed up the time it takes for generic forms of certain drugs, known as biosimilars, to get approved and made available to consumers.

“We know that one of the best ways to reduce the cost of insulin is to increase competition,” DeGette said. “Despite insulin being available for nearly 100 years now, there are still only three companies that manufacture the drug here in the U.S. and only one generic version of the drug available to consumers.”

Insulin belongs to a class of complex drugs known as “biologics,” which are exponentially more difficult for drug makers to manufacturer than “non-biologics,” such as aspirin.

While generic forms of a non-biologic drug, such as aspirin, can be made by simply mixing a precise amount of chemicals together, the process to make a generic version of a biologic drug, known as a “biosimilar,” is much more complicated and relies just as much on the process used to manufacture that drug, as it does on the ingredients involved.

In determining whether to deem a new drug safe for the market, the FDA will typically assume that if a generic version of a non-biologic drug, such as aspirin, has the exact same ingredients as the name-brand version, then it will be equally as safe for consumers to use.

But because generic versions of a biologic drug, such insulin, could have the same ingredients as the name brand version, yet behave entirely different simply because of the way it was manufactured, the FDA has treated these so-called biosimilars the same way it treats any other new drug trying to enter the marketplace – making their approval process much more lengthy and costly for companies to undertake.

The often rigorous and expensive approval process required for a drug maker to bring a generic form of insulin to the market has stifled competition.

To fix this, DeGette and Reed sent a letter in 2017 to the head of the FDA, Scott Gottlieb, urging him to create a new regulatory pathway that would help speed up the approval process for biosimilars by allowing drug makers to piggyback on some of the early clinical trials that the brand-name version of the drug used to get approved.

The lawmakers argued that by allowing drug makers seeking approval for a biosimilar to skip some of the early tests typically required for a new drug, it would make the process less time consuming and less costly – which, in turn, would entice more companies to produce more generic versions of biologic drugs, such as insulin, and eventually lower costs for consumers.

Shortly after DeGette and Reed sent their letter, the FDA issued new guidelines on Dec. 11, 2018, that created a new fast-track approval process for biosimilars, such as insulin, as the two lawmakers had suggested.  

The bill DeGette and Reed introduced today would now set those new FDA guidelines into law to prevent any future administrations from revoking them.